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 overall summary of research outcomes on Seeking Safety (excerpt from Najavits, in press). [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)
  4. Homeless women veterans (controlled trial) (Desai & Rosenheck, under review)
  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)

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 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.

A related article: Cohen LR, Hien DA. (under review). Can Complex PTSD inform our thinking about substance abusing women? Findings of a psychotherapy outcome study  For information on this article, contact: info@seekingsafety.org.   

(4) Homeless women veterans [controlled trial]

Desai RA & Rosenheck RA (under review).  Effectiveness of treatment for homeless female veterans with psychiatric and/or substance abuse disorders: Impact of "Seeking Safety" and residential treatment On one-year clinical outcomes.  Click here for the draft abstract.  [The final paper is not yet available.]

(5) Adolescent girls [randomized 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. 

(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. Clinician’s 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 clinician’s 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) 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] Note: once opened, go halfway down to view the article.

(13) 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.

 

(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.  

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 women’s 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 women’s 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)  For NIH studies, download Lisa Najavits' biosketch plus other support in NIH format

2)  For VA studies, download Lisa Najavits' VA biosketch and VA Other Support.   

3)  Certificate of completion (2006) of human subjects protection, updated 2007.

4)  Letter of support: see instructions. Please note in particular: email me the exact letter that you want both in content and format (please do not send a draft that says "fill in here", etc.).  I'll make minor edits if needed and then send you the letter on my letterhead, signed.  Also, as per the attached instructions, I only send a signed electronic copy; a hard copy from me to you by regular mail is not required by granting agencies. Thanks!  

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