Outcomes

This section provides:

Research on Seeking Safety

This section provides a summary and brief description of each completed study of Seeking Safety (as well as how to obtain the full article).  For descriptions of the Seeking Safety model and articles on implementing it, please go to Articles.

Summary of research on Seeking Safety

      Specific studies are below.  Please see also the 2010 overall summary of research outcomes on Seeking Safety. [Note: some of the studies below are not included in this summary, i.e., Young et al., Hills et al., Gatz et al.]

      Is Seeking Safety an "effective treatment"?  Yes, based on the research studies below, Seeking Safety meets criteria in the field as an effective treatment for PTSD/substance abuse (also known as an evidence-based practice).  See for example, Chambless & Hollon (1998), Defining empirically supported therapies. J Consulting and Clinical Psychology, 66, 7-18.

Specific studies

1. Women outpatients (Najavits et al., 1998)

2. Women in prison (Zlotnick et al., 2003)

3. Low-income urban women (randomized trial) (Hien et al., 2004; 2006)

4. Homeless women veterans (multisite controlled trial) (Desai et al., 2008, with correction letter 2009)

5. Adolescent girls (randomized trial) (Najavits et al., 2006)

6. Women with co-occurring disorder (controlled trial)  (Morrissey et al., 2005)

7. Women in a community mental health center (Holdcraft & Comtois, 2002)

8. Men and women veterans (Cook et al., 2006)

9. Men outpatients (Najavits et al., 2005)

10. Women veterans (Weller, 2005)

11. Women in community treatment (controlled trial) (Gatz et al., 2007)

12. Women in substance abuse treatment (Young et al., 2004)

13. Men veterans (Weaver et al., 2007); and reply [see 2nd page] (Najavits, 2007)

14. Young African-American men (Hamilton, 2006)

15. Dissemination study (Brown et al., 2007)

16. Dissemination study (Hills et al., 2004)

 

17. Women outpatients (master's thesis) (Mcnelis-Domingos, 2004)

 

18. Women in community treatment (using less than half of SS, i.e.,12 modules; randomized multisite trial):

        (a) Initial results (Hien, Wells et al, 2009)

        (b) PTSD improvements in relation to substance use outcomes (Hien , 2009)

        (c) Impact on HIV risk behavior (Hien, Campbell, Killeen et al., 2010)

        (d) Impact on alcohol use (Hien, Campbell, Ruglass et al., 2010)

        (e) Intervention safety (Killeen et al., 2008)

        (f) Alliance (Ruglass et al., in press)

 

19. Women in prison (randomized pilot study) (Zlotnick et al., 2009)

 

20. Veterans from Iraq and Afghanistan (using less than half of SS, i.e., 10 modules, and modified combination of them) (Norman et al., 2010)

 

21. Women in residential treatment (using less than one-fourth of SS, i.e., 6 modules) (Ghee et al., 2009).

 

22. Men soldiers (Lapointe, 2010).

 

23. Women in prison (controlled trial) (Lynch et al., 2011)

 

24. Men veterans (randomized trial) (Boden et al.; in press)

 

25. VA clinicians' ratings of treatments, including Seeking Safety (Najavits et al.2011).

 

26. Clients' treatment preferences, including Seeking Safety (Najavits, 2010)

A summary of each study is provided below; the complete article can be downloaded by clicking on the blue hyperlink or otherwise obtaining as noted.  Note: all below are Adobe Acrobat documents; to download Acrobat (free), click here. 

(1)  Women outpatients

Najavits LM, Weiss RD, Shaw SR, Muenz L. (1998). "Seeking Safety": Outcome of a new cognitive-behavioral psychotherapy for women with posttraumatic stress disorder and substance dependence.  Journal of Traumatic Stress, 11:437-456.

In this study, outcome results were reported for 17 women outpatients who completed group modality Seeking Safety treatment, with 25 sessions over 3 months.  Completion of the treatment was defined as six or more sessions (met by 63% of the 27 who enrolled).  All the women met criteria for current substance dependence and PTSD.  All had five or more lifetime traumas, with an average age of 7 at first trauma.  Sixty-five percent of the sample had one or more co-occurring personality disorders.  Forty-one percent had drug dependence, 41% alcohol dependence, and 18% both.  Assessments were conducted at pre-treatment, post-treatment, and 3-month follow-up. Results showed significant improvements in substance use (both alcohol and drug), trauma-related symptoms, suicide risk, suicidal thoughts, social adjustment, family functioning, problem solving, depression, cognitions about substance use, and didactic knowledge related to the treatment.  The only negative finding was a worsening of somatic symptoms (which may have been a function of substance withdrawal).  Patients� treatment attendance (67% of available sessions), alliance, and satisfaction were also very strong.  Treatment completers were more impaired than dropouts, yet more engaged in the treatment.  Overall, the data suggest that women with PTSD and substance abuse can be helped when provided with a treatment adapted to them.  All results are clearly tentative, however, due to the lack of a control group, external treatments the patients may have engaged in, multiple comparisons, and the lack of assessment on dropouts.

(2)  Women in prison

Zlotnick C, Najavits LM, Rohsenow DJ. (2003) A cognitive-behavioral treatment for incarcerated women with substance use disorder and posttraumatic stress disorder: Findings from a pilot study.  Journal of Substance Abuse Treatment, 25:99-105.  

This was a study of 17 women in a minimum-ecurity correctional setting, using group modality Seeking Safety treatment, with 25 sessions over 3 months (Zlotnick, Najavits & Rohsenow, under review).  All participants met criteria for current PTSD and substance dependence, and all had histories of repeated physical abuse, sexual abuse, or both (with an average age of 8 at first trauma).  The most common drug of choice was cocaine.  All of the women who were offered treatment began treatment. The attendance rate was 83% of sessions, and measures of client satisfaction and alliance were high.  Results showed that, of the 17 women, nine (53%) no longer met criteria for PTSD at the end of the three-month treatment; at a follow-up three months later, 46% still no longer met criteria for PTSD.  PTSD symptoms decreased significantly from pre-treatment to post-treatment, and this was maintained at the 3-month follow-up.  During incarceration, random urinalysis showed none of the women using a substance.  A follow up six weeks after release from prison indicated that 29% were using an illegal substance, and at three months after release the rate was 35%.  A significant decrease in drug and alcohol use, and legal problems was found from pre-treatment to both 6-weeks after release and 3-months after release.  Recidivism rate (return to prison) was 33% at three month followup, a rate typical of this population.  The treatment was rated equally helpful for PTSD and substance abuse, by the participants. 

(3)  Low-income urban women [randomized controlled trial]

Hien DA, Cohen LR, Litt LC, Miele GM, Capstick, C. (2004).  Promising empirically supported treatments for women with comorbid PTSD and substance use disorders. American Journal of Psychiatry, 161:1426-1432.

Objective: The authors' goal was to compare the efficacy of a manualized cognitive behavior therapy that addresses both posttraumatic stress disorder (PTSD) and substance abuse (seeking safety) with a manualized cognitive behavior therapy that addresses only substance abuse (relapse prevention) and with standard community care for the treatment of comorbid posttraumatic stress disorder (PTSD) and substance use disorder. Method: One hundred seven women from an urban, low-income population who had comorbid PTSD and substance use disorder were randomly assigned to receive the two kinds of cognitive behavior therapy or received standard community treatment. Participants were recruited from both community and clinical populations and evaluated with structured clinical instruments. Forty-one women received seeking safety therapy, 34 received relapse prevention therapy, and 32 received standard community care. Results: At the end of 3 months of treatment, participants in both cognitive behavior therapy conditions had significant reductions in substance use, PTSD, and psychiatric symptoms, but community care participants worsened over time. Both groups receiving cognitive behavior therapy sustained greater improvement in substance use and PTSD symptoms at 6-month and 9-month follow-ups than subjects in the community care group. Conclusions: Seeking safety and relapse prevention are efficacious short-term treatments for low-income urban women with PTSD, substance use disorder, and other psychiatric symptoms.

Cohen LR, Hien DA.(2006). Treatment outcomes for women with substance abuse and PTSD who have experienced complex trauma. Psychiatric Services, 57(1):100-106.

OBJECTIVE: This study assessed the effect of cognitive-behavioral therapy on a range of problems associated with complex trauma in a sample of women with comorbid substance use disorders and posttraumatic stress disorder (PTSD). METHODS: A total of 107 women with current or subthreshold PTSD and a current substance use disorder from an urban, low-income area were recruited from both community and clinical populations. Participants were recruited between 1997 and 2000. A quasi-experimental design was used, and participants who received cognitive-behavioral therapy (N=75) were compared with those in a control group who received no active study treatment (N=32). All participants were given the same list of community treatment resources and told that they could pursue services while participating in the study if they wished. RESULTS: At the end of treatment (three months postbaseline), compared with participants in the control group, those in the active treatment group showed significant reductions in symptoms of PTSD and alcohol use disorders, with a trend toward reductions in symptoms of drug use disorders. No significant differences were found between the groups on depression, dissociation, and social and sexual functioning outcomes. CONCLUSIONS: These findings underscore the challenge and necessity of addressing the unique and wide-ranging needs of women with substance use disorder who have been exposed to early and multiple interpersonal traumas.

(4) Homeless women veterans [controlled trial]

Desai RA et al. (2008). Treatment for homeless female veterans with psychiatric and substance abuse disorders: Impact of "Seeking Safety" on one-year clinical outcomes. Psychiatric Services, 59, 996-1003.  Desai, RA et al. (2009). Seeking Safety therapy: Clarification of results. Psychiatric Services, 60, 125.

Background.  Seeking Safety is a manualized cognitive-behavioral therapy designed to treat clients with comorbid substance abuse and trauma histories. In this study it was applied to homeless women veterans with psychiatric and/or substance abuse problems at eleven Homeless Women Veterans Programs.  The intervention consists of 25 sessions that cover topics to help build safety in clients' lives and is present-focused, offering psycho-education and coping skills.  Methods. A cohort of homeless women veterans (phase I, n=359) was recruited before Seeking Safety was implemented.  After clinicians were trained and certified in Seeking Safety a post-implementation cohort (phase II, n=91) was recruited and offered Seeking Safety treatment. All participants were interviewed every three months for one year and received intensive case management and other services during the study.  Mixed models were used to compare one-year clinical outcomes across phases.  Results.  At baseline, there were few differences between groups.  All women entering the program showed significant improvement on most clinical outcome measures.  The Seeking Safety cohort reported significantly better outcomes over one year in employment, social support, general symptoms of psychiatric distress, and symptoms of PTSD, particularly avoidance and arousal clusters. Conclusions.  Seeking Safety appears to have had a moderately beneficial impact on several clinical outcomes. While the non-equivalent comparison groups and low follow-up rates limit the internal validity of these results, availability of Seeking Safety may be of benefit for homeless female veterans. It is noteworthy that it could be delivered and implemented by case managers with little or no prior counseling experience. 

Correction to this article provides end-of-treatment outcomes (at six months) and major loss during followup. "In sum, at the end of treatment, participants in both Seeking Safety and the comparison condition evidenced consistent and positive outcomes on substance use and related areas. On two of 12 outcomes, differences between conditions favored the Seeking Safety intervention. Later time points (nine and 12 months) were a follow-up period for Seeking Safety, and sample attrition was substantial (the majority of the Seeking Safety sample was not assessed)."

(5) Adolescent girls [randomized controlled trial]

Najavits LM, Gallop RJ, Weiss RD. (2006). Seeking Safety therapy for adolescent girls with PTSD and substance abuse: A randomized controlled trial.  Journal of Behavioral Health Services & Research, 33, 453-463.

Objective: To evaluate outcomes of a manualized psychotherapy, Seeking Safety (SS), for posttraumatic stress disorder (PTSD) and substance use disorder (SUD) in adolescent females.  Thus far, no study has evaluated any treatment for this population.  Method: A randomized controlled trial of SS compared to treatment-as-usual (TAU) for 33 outpatients, with assessment at intake, post-treatment, and follow-up three months after treatment.  Measures targeted SUD, trauma-related symptoms, cognitions, functioning, attendance, and satisfaction with treatment.  Results: Participants in SS evidenced significantly better outcomes than TAU in a variety of domains at post-treatment, including substance use and associated problems, trauma-related symptoms, cognitions related to PTSD and SUD, psychiatric functioning, and several additional areas of pathology not targeted in the treatment (e.g., anorexia, somatization, generalized anxiety).  Some gains were sustained at follow-up.  SS patients attended an average of 12 sessions and reported moderate satisfaction and alliance.  Conclusions:  SS appears a promising treatment for this population, but there is a need for further study and perhaps additional clinical modification (e.g., more intensive and/or longer SS treatment). 
 

(6) Women with co-occurring disorders [multi-site controlled trial, with Seeking Safety at 4 of the 9 sites]

Morrissey, JP, Jackson, EW, Ellis, AR, Amaro, H, Brown, VB, Najavits, LM. (2005). Twelve-month outcomes of trauma-informed interventions for women with co-occurring disorders. Psychiatric Services, 56, 1213-1222.

Objective: Women with co-occurring mental health and substance use disorders frequently have a history of interpersonal violence, and past research has suggested that they are not served effectively by the current service system. The goal of the Women, Co-occurring Disorders, and Violence Study was to develop and test the effectiveness of new service approaches specifically designed for these women. Method: A quasi-experimental treatment outcome study was conducted from 2001 to 2003 at nine sites. Although intervention specifics such as treatment length and modality varied across sites, each site used a comprehensive, integrated, trauma-informed, and consumer-involved approach to treatment. Substance use problem severity, mental health symptoms, and trauma symptoms were measured at baseline, and follow-up data were analyzed with prospective meta-analysis and hierarchical linear modeling. Results: A total of 2,026 women had data at the 12-month follow-up: 1,018 in the intervention group and 1,008 in the usual-care group. For substance use outcomes, no effect was found. The meta-analysis demonstrated small but statistically significant overall improvement in women's trauma and mental health symptoms in the intervention relative to the usual-care comparison condition. Analysis of key program elements demonstrated that integrating substance abuse, mental health, and trauma-related issues into counseling yielded greater improvement, whereas the delivery of numerous core services yielded less improvement relative to the comparison group. A few person-level characteristics were associated with increases or decreases in the intervention effect. These neither moderated nor supplanted the effects of integrated counseling. Conclusions: Outcomes for women with co-occurring disorders and a history of violence and trauma may improve with integrated treatment.

Cocozza JJ, Jackson EW, Hennigan K, Morrissey JP, Reed BG, Fallot R, et al. (2995). Outcomes for women with co-occurring disorders and trauma: program-level effects. Journal of Substance Abuse Treatment, 28(2):109-119.

Program-level effects at 6 months are reported from meta-analysis of a nine-site quasi-experimental study of comprehensive, integrated, trauma-informed, and consumer-involved services for women who have mental health problems, substance use disorders, and who have experienced interpersonal violence. The average weighted effect size is significant for the treatment condition for improved post-traumatic symptoms (p < 0.02), drug use problem severity (p < 0.02), and nearly significant for mental health symptoms (p < 0.06). There is significant heterogeneity in effect sizes across sites. Program-level variables were examined in an effort to explain this heterogeneity. The findings indicate that sites which provided significantly more integrated counseling produced more favorable results in mental health symptoms (p < 0.01) and both alcohol (p < 0.001) and drug use problem severity (p < 0.001). The same trend is observable for reductions in post-traumatic stress symptoms, although the difference does not attain statistical significance.

Domino M, Morrissey JP, Nadlicki-Patterson T, Chung S. (2005). Service costs for women with co-occurring disorders and trauma. Journal of Substance Abuse Treatment,28(2):135-43.

Several aspects of costs related to health care and other service use at 6-month follow-up are presented for women with co-occurring mental health and substance abuse disorders with histories of physical and/or sexual abuse receiving comprehensive, integrated, trauma-informed and consumer/survivor/recovering person-involved interventions (n = 1023) or usual care (n = 983) in a nine-site quasi-experimental study. Results show that, controlling for pre-baseline use, there are no significant differences in total costs between participants in the intervention condition and those in the usual care comparison condition, either from a governmental (avg. US dollars 13,500) or Medicaid reimbursement perspectives (avg. just over US dollars 10,000). When combined with clinical outcomes analyzed in other works in this issue by Cocozza et al. (2005) and Morrissey et al. (2005), which favored the intervention sites, these cost findings indicate that the treatment intervention services are cost-effective as compared with the usual care received by women at the comparison sites.

(7)  Women in a community mental health center 

Holdcraft, L.C. & Comtois, K.A. (2002). Description of and preliminary data from a women's dual diagnosis community mental health program. Canadian Journal of Community Mental Health: 21:91-109.

This is a preliminary study of 20 women in an outpatient women�s mental health and dual diagnosis treatment program at a community mental health center. The Harborview Mental Health Services Women�s Dual Diagnosis Program incorporates empirically based treatments such as cognitive behavioral therapy for dual disorders, Dialectical Behavior Therapy and contingency management into a comprehensive, integrated dual diagnosis program. This article gives a clinical description of the program and a comparison of outcome variables at pre-treatment compared to one year into treatment.  As this is a report on a program that underwent clinical development, some individuals with active substance abuse initially received the Substance Abuse Management Model (SAMM; Roberts, Shaner, & Eckman) substance abuse group treatment prior to receiving Seeking Safety.  Due to the concern that the SAMM material did not specifically target several concerns relevant to women who are dually diagnosed including preventing substance use in response to emotional dysregulation, the substance abuse group treatment was changed to Najavits' Seeking Safety. This was much better received by the women in our program.  In addition to providing Seeking Safety treatment, the women�s program also offered Dialectical Behavior Therapy (DBT) skills training groups, didactics on women�s issues, and a community support group. Individual skills coaching or individual therapy was provided to help clients integrate DBT skills with those from the Seeking Safety manual. Results indicated that psychiatric hospitalizations significantly dropped from and average of about two hospitalizations in the year prior to entering treatment to less than one in the first year of treatment. The average length of sobriety (which included those who entered the program with sustained sobriety) significantly increased by six months one year later. When examining only those with less than one year of sobriety before entering the program, results remained significant with approximately a 5-month increase in sobriety. Clinicians' ratings indicated significant improvement in psychiatric condition by more than one point on a seven-point scale. Participants also improved significantly with respect to housing and productivity.  Trends were shown for improved perception of quality of life and clinicians' perception of global functioning.  Preliminary data indicates that this approach has excellent effectiveness in areas such as psychiatric hospitalization, sobriety, productivity, and housing. 

(8) Men and women veterans 

Cook, J.M., Walser, R.D., Kane, V., Ruzek, J. I., Woody, G. (2006).  Dissemination and feasibility of a cognitive-behavioral treatment for substance use disorders and posttraumatic stress disorder in the Veterans Administration. Journal of Psychoactive Drugs, 38, 89-92.

This paper describes a small dissemination effort and provides initial efficacy data of a cognitive-behavioral treatment for co-morbid substance use disorders (SUD) and posttraumatic stress disorder (PTSD), Seeking Safety, in a VA setting. After providing a daylong interactive training in Seeking Safety to front-line clinicians, a co-therapist group practice model was implemented. Following 14 months of clinician training an uncontrolled pilot study of four groups with 18 veterans, initial efficacy data indicate significant symptom reduction for patients and acceptability to clinicians. Findings are encouraging in that Seeking Safety treatment appears to have the potential to be beneficial for veterans with SUD-PTSD and appeal to clinicians. Dissemination of Seeking Safety is feasible in the VA, yet there are likely barriers to sustaining it as a routine treatment. Recommendations for future dissemination are proposed, including ways VA administration can facilitate this process.

(9)  Men outpatients

Najavits, LM, M. Schmitz, S. Gotthardt, S., Weiss, R.D. (2005). Seeking Safety plus Exposure Therapy for Dual Diagnosis Men. Journal of Psychoactive Drugs, 27, 425-435.

This study of 5 outpatient men evaluated a combination of Seeking Safety plus Exposure Therapy-Revised, using individual treatment. They were offered 30 sessions over 5 months, with the option to select how much of each type of treatment they preferred on a session-by-session basis.  All patients met criteria for current PTSD and substance dependence, with childhood trauma the basis of the PTSD.  They had an average of 9.6 different types of trauma (all non-combat), with an average first trauma at 8 years old.  They reported an average of 22 days with drug problems in the prior month, and 6 days of alcohol problems. The Exposure Therapy-Revised component was an adaptation of Foa and Rothbaum's exposure therapy (1998), modified for PTSD and SUD.  The modifications were designed to increase the acceptability and safety of exposure therapy in substance abuse patients, using a variety of "safety parameters". Outcome results showed significant improvements in drug use; family/social functioning; trauma symptoms; anxiety; dissociation; sexuality; hostility; overall functioning; meaningfulness; and feelings and thoughts related to safety.  All five patients attended all 30 sessions, and they chose an average of 21 Seeking Safety sessions and 9 Exposure Therapy-Revised sessions.  Treatment satisfaction and alliance were very high.  The need for further evaluation using more rigorous methodology is discussed.   

(10) Women veterans

Weller LA (2005). Group therapy to treat substance use and traumatic symptoms in female veterans. Federal Practitioner, 27-38. [no abstract in article]

(11) Women in community treatment

Gatz  M, Brown V, Hennigan K, Rechberger E, O'Keefe M, Rose T, Bjelejac P, 2007), Effectiveness of an integrated trauma-informed approach to treating women with co-occurring disorders and histories of trauma. J. Community Psychology, 35, 863-878.

Effectiveness of an integrated trauma-informed approach to treating women with co-occurring disorders and histories of trauma was evaluated. Baseline and 12-month assessments were completed by 136 intervention and 177 comparison group women. The intervention group received Seeking Safety, a trauma-specific group treatment focusing on safety and coping skills, in the context of integrated substance abuse and mental health services. The comparison group received similar services but not trauma-specific group treatment. Intervention women showed significantly better treatment retention over three months and greater improvement on posttraumatic stress symptoms and coping skills. Those who completed treatment improved more than those who discontinued on most outcomes. Improvements on symptoms of distress and drug problem severity were partially mediated by gains in coping skills.

(12) Women in substance abuse treatment

Young, M.S., Hills, H.A., Rugs, D., Peters, R., Moore, K., Woods-Brown, L., & Pape, L. (2004, July). Integrating Seeking Safety into substance abuse treatment programs. Paper presented at the 112th annual meeting of the American Psychological Association, Honolulu, HI.
 
Eight substance abuse programs in the Tampa Bay area implemented Seeking Safety as part of the Tampa Practice Improvement Collaborative.  Data were collected from 220 women who participated in Seeking Safety in community treatment settings. Repeated measures were completed by 99 women, who comprise the sample for this outcome analysis.  Average duration between intake and final assessment was 3.5 months. The sample was primarily minority (46% Caucasian, 38% African American, 9% Hispanic, 3% other). Most (80%) had children, and most (69%) has problem use of multiple substances.   Significant improvements found on the Trauma Symptom Checklist 40 (overall, and 5 subscales); the Brief Symptom Inventory (all 3 global scales and 6 of 9 subscales). Of the 31 women with PTSD at intake, only 8 met criteria for PTSD at end of treatment. Conclusion: Results encourage the use of Seeking Safety in the context of substance abuse treatment.

(13) Men veterans

Weaver CM, Trafton JA, Walser RD, Kimerling RE (2007). Pilot test of Seeking Safety with male veterans.  Psychiatric Services, 58, 1012. [no abstract]. Also, see reply: Najavits, LM (2007). Letter to the editor: Reply to Weaver et al. (2007). Psychiatric Services 2007;58:1376 (scroll halfway down to view it).

 

(14) Young African-American men

 

Hamilton, N. (2006). African-American Center for Excellence (AACE) Program; SAMHSA grant number TI14126; final report. Unpublished report, Operation PAR (Largo, Florida). Click here for a summary.

(15) Dissemination study

(Brown et al., 2007). Implementing an evidence-based practice: Seeking Safety group. Journal of Psychoactive Drugs, 39, 231-240.

This paper presents findings from a multi-site study on adopting and implementing an evidence-based practice, Seeking Safety, for women with co-occurring disorders and experiences of physical and sexual abuse. We focus upon what implementation decisions different sites made to optimize the compatibility of Seeking Safety with the site�s needs and experiences and on issues posed by Rogers (1995) as relevant to successful diffusion of an innovative practice. A total of 157 clients and 32 clinicians reported on satisfaction with various aspects of the model. We also examined cross-site differences. Results show that Seeking Safety appears to be an intervention that clinicians perceive as highly relevant to their practice, and one that adds value. Clients perceive the treatment as uniquely touching on their needs in a way that previous treatments had not.

(16) Dissemination study

Rugs D, Hills HA, Peters R (2004, June). Diffusion of research in practice in substance abuse treatment: A knowledge adoption study of gender-sensitive treatment. Presented at the conference, Complexities of Co-Occurring Conditions: Harnessing Services Research to Improve Care for Mental, Substance Use and Medical/Physical Disorders, Washington DC. This joint conference was sponsored by the National Institute of Mental Health, the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, the Agency for Healthcare Research and Quality, the Health Resources and Services Administration, and the Substance Abuse and Mental Health Services Administration.

This SAMHSA study by Young et al. (2004) compared basic versus enhanced training on Seeking Safety to evaluate adoption patterns for the model. The basic training was offering the book alone. The enhanced training included the book plus in-person training and on-going supervision. Two groups of clinicians were compared: n=55 in the book-alone versus n=49 in the enhanced condition. 405 clients were treated in Seeking Safety groups by the clinicians during the study. The treatment was perceived as �very well received� or �well received� by the vast majority. At the end of the study, 95% of the enhanced condition reported using the manual, with 97% reporting that they would use the manual over the next six months. In the book-alone condition, the rates were 41% and 82% respectively. Also, significantly more of the enhanced-training participants than book-alone participants reported at the study�s end that they would use �all of the manual.�

(17)  Women outpatients (master's thesis)

Mcnelis-Domingos A (2004).Cognitve behavioral skills training for persons with co-occuring posttraumatic stress disorder and substance abuse. Thesis submitted for the degree of Master of Social Work, Southern Connecticut State University, New Haven, Connecticut, May, 2004. For information on this study, email annmcnelis@excite.com

The purpose of this study was to assess the effectiveness of Cognitive Behavioral Skill Therapy techniques with adults that have a diagnosis of co-occurring substance abuse and posttraumatic Stress Disorder (PTSD).  The design was a pre-experimental, static-group comparison design, comparing persons who have completed the Seeking Safety Program to persons who were referred to this intervention, but had not yet received it.   Participants for the comparison group were a convenience sample, five (n=5) women who met the DSM-IV-TR criteria for substance abuse of alcohol, cocaine, or marijuana and who have a diagnosis, or who exhibit symptoms of PTSD.  Participants for the intervention group were a convenience sample, five (n=5) women who had completed the Seeking Safety Program.  The research study sample was drawn from outpatient clients of the APT Foundation.  The intervention was the Seeking Safety Program.  Urine toxicology screens, post-test for symptoms of PTSD, Trauma Symptom Checklist ( TSC-40), and a self-report post-test of coping skills used by clients to manage their substance abuse and PTSD were compared across the intervention and comparison groups.  The potential implications of the findings from this study for clinical social work practice is to suggest that the Seeking Safety Program may reduce substance use, while increasing the use of coping skills to manage substance abuse and perhaps symptoms of PTSD.  

(18) Women in community treatment (using less than half of SS, i.e.,12 modules)

The papers below are from the National Institute on Drug Abuse (NIDA) Clinicial Trials Network study on Seeking Safety.

     (a) Initial results.

Hien DA, Wells EA, Jiang H, Suarez-Morales L, Campbell AN, Cohen LR, et al. (2009). Multisite randomized trial of behavioral interventions for women with co-occurring PTSD and substance use disorders. Journal of Consulting and Clinical Psychology, 77(4):607-19.

The authors compared the effectiveness of the Seeking Safety group, cognitive-behavioral treatment for substance use disorder and posttraumatic stress disorder (PTSD), to an active comparison health education group (Women's Health Education [WHE]) within the National Institute on Drug Abuse's Clinical Trials Network. The authors randomized 353 women to receive 12 sessions of Seeking Safety (M = 6.2 sessions) or WHE (M = 6.0 sessions) with follow-up assessment 1 week and 3, 6, and 12 months posttreatment. Primary outcomes were the Clinician Administered PTSD Scale (CAPS), the PTSD Symptom Scale-Self Report (PSS-SR), and a substance use inventory (self-reported abstinence and percentage of days of use over 7 days). Intention-to-treat analysis showed large, clinically significant reductions in CAPS and PSS-SR symptoms (d = 1.94 and 1.12, respectively) but no reliable difference between conditions. Substance use outcomes were not significantly different over time between the two treatments and at follow-up showed no significant change from baseline. Study results do not favor Seeking Safety over WHE as an adjunct to substance use disorder treatment for women with PTSD and reflect considerable opportunity to improve clinical outcomes in community-based treatments for these co-occurring conditions.

     (b) PTSD improvements in relation to substance use outcomes

Hien DA, Jiang H, Campbell AN, Hu MC, Miele GM, Cohen LR, et al. (2009). Do Treatment Improvements in PTSD Severity Affect Substance Use Outcomes? A Secondary Analysis From a Randomized Clinical Trial in NIDA's Clinical Trials Network. American Journal of Psychiatry, 167: 95-101.

Objective: The purpose of the analysis was to examine the temporal course of improvement in symptoms of posttraumatic stress disorder (PTSD) and substance use disorder among women in outpatient substance abuse treatment. Method: Participants were 353 women randomly assigned to 12 sessions of either trauma-focused [Seeking Safety] or health education group treatment. PTSD and substance use assessments were conducted during treatment and posttreatment at 1 week and after 3, 6, and 12 months. A continuous Markov model was fit on four defined response categories (nonresponse, substance use response, PTSD response, or global response [improvement in both PTSD and substance use]) to investigate the temporal association between improvement in PTSD and substance use symptom severity during the study's treatment phase. A generalized linear model was applied to test this relationship over the follow-up period. Results: Subjects exhibiting nonresponse, substance use response, or global response tended to maintain original classification; subjects exhibiting PTSD response were significantly more likely to transition to global response over time, indicating maintained PTSD improvement was associated with subsequent substance use improvement. Trauma-focused treatment [Seeking Safety] was significantly more effective than health education in achieving substance use improvement, but only among those who were heavy substance users at baseline and had achieved significant PTSD reductions. Conclusions: PTSD severity reductions were more likely to be associated with substance use improvement, with minimal evidence of substance use symptom reduction improving PTSD symptoms. Results support the self-medication model of coping with PTSD symptoms and an empirical basis for integrated interventions for improved substance use outcomes in patients with severe symptoms.

     (c) Impact on HIV risk behavior

Hien DA, Campbell AN, Killeen T, Hu MC, Hansen C, Jiang H, et al. (2010). The impact of trauma-focused group therapy upon HIV sexual risk behaviors in the NIDA Clinical Trials Network "Women and trauma" multi-site study. AIDS Behavior,14(2):421-430.

Women in drug treatment struggle with co-occurring problems, including trauma and post-traumatic stress disorder (PTSD), which can heighten HIV risk. This study examines the impact of two group therapy interventions on reduction of unprotected sexual occasions (USO) among women with substance use disorders (SUD) and PTSD. Participants were 346 women recruited from and receiving treatment at six community-based drug treatment programs participating in NIDA's Clinical Trials Network. Participants were randomized to receive 12-sessions of either Seeking Safety (SS), a cognitive behavioral intervention for women with PTSD and SUD, or women's health education (WHE), an attention control psychoeducational group. Participants receiving SS who were at higher sexual risk (i.e., at least 12 USO per month) significantly reduced the number of USO over 12-month follow up compared to WHE. High risk women with co-occurring PTSD and addiction may benefit from treatment addressing coping skills and trauma to reduce HIV risk.

     (d) Impact on alcohol use

Hien DA, Campbell AN, Ruglass LM, Hu MC, Killeen T. (2010). The role of alcohol misuse in PTSD outcomes for women in community treatment: a secondary analysis of NIDA's Women and Trauma Study. Drug and Alcohol Dependence;111(1-2):114-119.

BACKGROUND: Individuals with comorbid substance use and posttraumatic stress disorder may differentially benefit from integrated trauma-focused interventions based on specific presenting characteristics such as substance use type and PTSD severity. The current study is a secondary analysis of a NIDA Clinical Trials Network study exploring the effectiveness of two interventions for women with comorbid PTSD and substance use disorders. METHOD: Generalized estimating equations were used to examine the association of baseline alcohol misuse with PTSD outcome measures over time for all randomized participants. RESULTS: Women entering treatment with baseline alcohol misuse had higher Post Traumatic Stress Disorder Symptom Scale (PSS-SR) total scores (t=2.43, p<.05), cluster C (avoidance/numbing) scores (t=2.63, p<.01), and cluster D (hyper-arousal) scores (t=2.31, p<.05). For women with alcohol misuse, after treatment week 1, PSS-SR scores were significantly lower in the Seeking Safety intervention during treatment (chi(2)(1)=4.00, p<.05) and follow-up (chi(2)(1)=4.87, p<.05) compared to those in the health education intervention. Alcohol misusers in the Seeking Safety group who had higher baseline hyper-arousal severity improved more quickly than those with lower baseline hyper-arousal severity during treatment (chi(2)(1)=4.06, p<.05). CONCLUSIONS: These findings suggest that the type of substance abuse at treatment entry may inform treatment selection, predict treatment response among those with co-occurring PTSD and substance use disorders, and indicate a more severe clinical picture.

     (e) Intervention safety

Killeen T, Hien D, Campbell A, Brown C, Hansen C, Jiang H, et al. (2008). Adverse events in an integrated trauma-focused intervention for women in community substance abuse treatment. Journal of Substance Abuse Treatment 35(3):304-311.

A substantial number of women who enter substance abuse treatment have a history of trauma and meet criteria for posttraumatic stress disorder (PTSD). Fear regarding the extent to which PTSD treatment can evoke negative consequences remains a research question. This study explored adverse events related to the implementation of an integrated treatment for women with trauma and substance use disorder (Seeking Safety) compared with a nontrauma-focused intervention (Women's Health Education). Three hundred fifty-three women enrolled in community substance abuse treatment were randomized to 1 of the 2 study groups and monitored weekly for adverse events. There were no differences between the two intervention groups in the number of women reporting study-related adverse events (28 [9.6%] for the Seeking Safety group and 21[7.2%] for the Women's Health Education group). Implementing PTSD treatment in substance abuse treatment programs appears to be safe, with minimal impact on intervention-related adverse psychiatric and substance abuse symptoms. More research is needed on the efficacy of such interventions to improve outcomes of PTSD and substance use.

     (f) Alliance

(19) Women in prison

Zlotnick C, Johnson J, Najavits LM. (2009). Randomized controlled pilot study of cognitive-behavioral therapy in a sample of incarcerated women with substance use disorder and PTSD. Behavior Therapy, 40(4):325-36.

This randomized controlled pilot study compared a cognitive-behavioral therapy (Seeking Safety; SS) plus treatment-as-usual (TAU) to TAU-alone in 49 incarcerated women with substance use disorder (SUD) and posttraumatic stress disorder (PTSD; full or subthreshold). Seeking Safety consisted of a voluntary group treatment during incarceration and individual treatment after prison release. TAU was required in the prison and comprised 180 to 240 hours of individual and group treatment over 6 to 8 weeks. Assessments occurred at intake, 12 weeks after intake, and 3 and 6 months after release from prison. There were no significant differences between conditions on all key domains (PTSD, SUD, psychopathology, and legal problems); but both conditions showed significant improvements from intake to later time points on all of these outcomes across time. Secondary analyses at follow-up found trends for SS participants improving on clinician-rated PTSD symptoms and TAU participants worsening on self-reported PTSD symptoms. Also, SS demonstrated continued improvement on psychopathology at 3 and 6 months, whereas TAU did not. However, alcohol use improved more for TAU during follow-up. Satisfaction with SS was high, and a greater number of SS sessions was associated with greater improvement on PTSD and drug use. Six months after release from prison, 53% of the women in both conditions reported a remission in PTSD. Study limitations include lack of assessment of SS outcomes at end of group
treatment; lack of blind assessment; omission of the SS case management component; and possible contamination between the two conditions. The complex needs of this population are discussed.

(20) Veterans from Iraq and Afghanistan (using less than half of SS, i.e., 10 modules, and modified combination of them)

Norman SB, Wilkins KC, Tapert SF, Lang AJ, Najavits LM. A pilot study of seeking safety therapy with OEF/OIF veterans. Journal of Psychoactive Drugs 2010;42:83-87.

PTSD and substance use disorder (SUD) are highly prevalent among Veterans returning from Iraq and Afghanistan (Operation Enduring Freedom/Operation Iraqi Freedom; OEF/OIF). Seeking Safety (SS) is a cognitive-behavioral psychotherapy for co-occurring PTSD/SUD. This pilot study with fourteen male OEF/OIF Veterans suggests that SS may help to reduce alcohol use, PTSD, and depression in some participants at clinically significant levels, even when providing less than half of the full model. We emphasize several SS features as especially helpful: the case  management component to help engage clients in further mental health and SUD care; offering PTSD as an entry point, and emphasis on community resources. Issues particular to Veterans include reintegration to civilian life and supporting Veterans’ connection with other Veterans.

(21) Women in residential treatment (using less than one-fourth of SS, i.e., 6 topics)

Ghee AC, Bolling LC, Johnson CS. (2009). The efficacy of a condensed Seeking Safety intervention for women in residential chemical dependence treatment at 30 days posttreatment. Journal of Child Sexual Abuse,18(5):475-488.

This study examined the efficacy of a condensed version of the Seeking Safety intervention in the reduction of trauma-related symptoms and improved drug abstinence rates among women in residential chemical dependence treatment. One hundred and four women were randomly assigned to treatment including a condensed (six session) Seeking Safety intervention or the standard chemical dependence intervention. The Seeking Safety participants reported lower sexual-abuse-related trauma symptoms at 30 days posttreatment as compared to participants who received only standard treatment. However, the condensed Seeking Safety intervention was not more advantageous in reducing overall trauma symptoms or relapse 30 days after treatment ended.

(22) Men soldiers

Lapointe, R (2010). Group intervention using the Seeking Safety model for military patients with posttraumatic stress disorder and substance abuse

[Abstract only; for further information contact renee_claudelapointe@hotmail.com]

This study evaluated "Seeking Safety" with soldiers suffering from posttraumatic stress disorder (PTSD) and  substance abuse (drugs and / or alcohol), using the French-language translation of the book. The issue of comorbidity between PTSD and substance abuse (drugs and / or alcohol) is very prevalent in the military. Seeking Safety had not previously been studied with French Canadian service members. All participants were military personnel within the Canadian Forces, with diagnosed PTSD related to war and substance abuse (drugs and / or alcohol). They all volunteered to participate in group therapy. It was a group of eight participants at baseline. The attendance rate was high. Two participants had drug problems; the others had alcohol problems. During this program, most participants had improvements in their states of posttraumatic PTSD and substance use (drugs and / or alcohol). Indeed, three soldiers completely stopped drinking alcohol during the program. All would have preferred a longer therapy; indeed, 14 weeks seemed too short a time.

(23) Women in prison compared to waitlist

Lynch, SM, Heath, NM, Matthews, KC, Cepeda, GJ (2011). Seeking Safety: An intervention for trauma exposed incarcerated women?

http://www.tandfonline.com/doi/abs/10.1080/15299732.2011.608780

Recent guidelines for incarcerated women's programming have called for interventions that address offenders' traumatic experiences, PTSD, and substance use in an integrated manner. Seeking Safety (SS) is an empirically supported cognitive behavioral manualized treatment for individuals with PTSD and substance use disorders. This study examined the effectiveness of SS with 59 incarcerated women who completed the intervention and 55 who were waitlisted. Participants in SS demonstrated greater symptom improvement in PTSD and depression as well as improved interpersonal functioning and coping as compared to waitlisted offenders. These findings provide preliminary support for the use of this intervention with incarcerated women.

(24)  Men veterans

Boden MT, Kimerling R, Jacobs-Lentz J, Bowman D, Weaver C, Carney D, Walser R, Trafton JA. (in press). Seeking Safety treatment for male veterans with a substance use disorder and PTSD symptomatology. Addiction.

Aims: To determine whether substituting Seeking Safety (SS), a manualized therapy for comorbid substance use disorders (SUD) and posttraumatic stress disorder (PTSD), for part of treatment as usual (TAU) improves substance use outcomes. Design: Randomized controlled effectiveness trial. Settings: Outpatient Veterans Administration Health Care System SUD clinic. Participants: 98 male military Veterans with a SUD and co-occurring PTSD symptomatology. Measurements: Drug and alcohol use and PTSD severity, measured at the first day of treatment, and three- (i.e., the planned end of SS sessions), and six-months following the baseline assessment. Treatment attendance and patient satisfaction were measured following treatment (3-month follow-up). Active coping was measured at treatment intake and following treatment. Findings: SS compared to TAU was associated with better drug use outcomes, and alcohol use and PTSD severity decreased equally under both treatments. SS versus TAU was associated with increased treatment attendance, client satisfaction and active coping. However, neither these factors nor decreases in PTSD severity mediated the effect of treatment on drug use. Conclusions: The manualised treatment approach for substance use disorder, Seeking Safety, is well received and associated with better drug use outcomes than 'treatment as usual' in male veterans with posttraumatic stress disorder.

(25) VA clinicians' ratings of treatments (including Seeking Safety)

Najavits, LM, Kivlahan, D, Kosten, T (2011). A national survey of clinicians' views of evidence-based therapies. Addiction Research and Theory, 19, 138-147 

We surveyed 205 Veterans Affairs (VA) staff on treatment of posttraumatic stress disorder (PTSD), substance use disorder (SUD), and the combination (PTSD/SUD).
The survey was anonymous and VA-wide. PTSD/SUD was perceived as more difficult to treat than either disorder alone; gratification in the work was stronger than difficulty (for PTSD, SUD, and PTSD/SUD); and difficulty and gratification
appeared separate constructs. Respondents endorsed views that represent expert treatment for the comorbidity; however, there was also endorsement of “myths.” Thus, there is a need for more training, policy clarifications, service integration,
and adaptations for veterans returning from Iraq and Afghanistan. Limitations are described.

(26) Clients treatment preferences (including Seeking Safety)

Najavits, LM. (2010). Treatments for PTSD and pathological gambling: What do patients want? Journal of Gambling Studies, DOI 10.1007/s10899-010-9198-9

This study explored the treatment preferences of 106 people with posttraumatic
stress disorder (PTSD), pathological gambling (PG), or both. It is the first know study of its type for this comorbidity. Sixteen different treatment types were rated, with a broad array of modalities including manualized psychotherapies, medication, self-help, alternative therapies, coaching, and self-guided treatments (use of books and computerized therapy). A consistent finding was that PTSD treatments were rated more highly than PG treatments, even among those with both disorders. Further, of the sixteen treatment types, the sample expressed numerous preferences for some over others. For example, among PG treatments, self-help was the highest-rated. Among PTSD treatments, psychotherapies were the highest-rated; and individual therapy was rated higher than group therapy. For both PG and PTSD, medications were rated lower than other treatment types. Non-standard treatments
(i.e., computerized treatment, books, coaching, family therapy, alternative therapies) were generally rated lower than other types. Discussion includes implications for the design of treatments, as well as methodological limitations.

Other studies are currently on-going.

Study on A Woman's Addiction Workbook

Najavits LM, Rosier M, Nolan AL, Freeman MC (2007). A new gender-based model for womens recovery from substance abuse: Results of a pilot outcome study. American Journal of Drug and Alcohol Abuse, 33, 5-11.    

Despite repeated calls for gender-based recovery models for women, there has been a lack of empirical studies on this topic. We thus sought to evaluate a womens manual-based substance use disorder recovery model in a pilot study. Participants were opioid-dependent women in a methadone maintenance treatment program who received 12 sessions of the gender-based model in group format over two months. Assessment was conducted before and after the intervention, with results indicating significant improvements in drug use (verified by urinalysis), impulsive-addictive behavior, global improvement, and knowledge of the treatment concepts. Patients high attendance rate (87% of available sessions) and strong treatment satisfaction additionally support the potential use of this treatment model. Future research would benefit from larger samples and enhanced scientific methodology.

Your research

If you are interested in conducting research on Seeking Safety or A Woman's Addiction Workbook, I would be happy to assist with information and suggestions.  I support research efforts on these in whatever ways I can, ranging from serving as a consultant to grants, providing informal phone consultation, providing copies of "under review" articles, and helping you get in touch with others who are already conducting studies on Seeking Safety or A Woman's Addiction Workbook.  

Several specific suggestions: First, please first read this web page in detail, including downloading relevant articles and materials, following the links and ideas in the assessment section, etc.  Second, consider modeling your study on one or more prior studies on Seeking Safety.  See the completed studies above and read those articles for examples of study design, measures, analyses, etc.  You can also download the article: Najavits LM (2003). How to design an effective treatment outcome study. Journal of Gambling Studies, 19:317-337. If you have further questions, please feel free to contact Lisa Najavits.   

Grant materials

1)  Biosketches: NIH format biosketch (updated 12/09); VA format biosketch and VA Other Support.   

2)  Training Certificates: Citi Training (human subjects protection, 2009); VA training certificates, including Citi Training (2009)

3)  Letter of support: please email (a) your deadline; and (b) the exact letter that you want both in content and format (please do not send a draft to fill in). The letter will be sent back on letterhead, signed, pdf format.  

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