Najavits, L. M., Weiss, R. D., Shaw, S. R., & 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.

Type of Study: Uncontrolled trial
Number of Participants: 27

Population:

• Age range — 18 or older
• Race/Ethnicity — 88% Caucasian, 12% African-Americans
• Gender — Not Specified
• Status — Outpatient women with current PTSD and substance use disorder.

Location / Institution: Boston area

Summary: (To include comparison groups, outcomes, measures, notable limitations)
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. Results are limited 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.

Length of post-intervention follow-up: 3 months.

Zlotnick C., Najavits L. M., & Rohsenow, D. J. (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.

Type of Study: Uncontrolled trial
Number of Participants: 17

Population:

• Age range — 21 or older
• Race/Ethnicity — 67% Caucasian, 11% African-American, 6% Hispanic, and 17% other and/or multiracial.
• Gender — Not Specified
• Status — Women in prison with current substance dependence and PTSD.

Location / Institution: Rhode Island

Summary: (To include comparison groups, outcomes, measures, notable limitations)
This was a study of 17 women in a minimum-security correctional setting, using group modality Seeking Safety treatment, with 25 sessions over 3 months. 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; and 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 follow-up, a rate typical of this population.

Length of post-intervention follow-up: 3 months on PTSD and 6 weeks or 3 months after release for substance use.

Hien, D. A., Cohen L. R., Litt, L. C., Miele, G. M., & Capstick, C. (2004). Promising empirically supported treatments for women with comorbid PTSD and substance use disorders. American Journal of Psychiatry, 161, 1426-1432.

Type of Study: Randomized controlled trial
Number of Participants: 107

Population:

• Age range — 18 or older
• Race/Ethnicity — Seeking Safety: 49% African-American, 24% Caucasian, 24% Hispanic, and 2% Other and/or multiiracial; Relapse Prevention: 50% Caucasian, 35% African-American, and 15% Hispanic; Community Care: 41% African-American, 41% Caucasian, and 19% Hispanic.
• Gender — Not Specified
• Status — Low-income urban women, outpatient with current PTSD (full or subthreshold) and substance use disorder

Location / Institution: New York City

Summary: (To include comparison groups, outcomes, measures, notable limitations)
This study compared 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. One hundred and seven women from an urban, low-income population who had comorbid PTSD and substance use disorder were randomly assigned to receive one of the two kinds of cognitive behavior therapy or 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. At the end of 3 months of treatment, participants in both Seeking Safety and Relapse Prevention had significant reductions in substance use, PTSD, and psychiatric symptoms, but community care participants worsened over time. Participants in both Seeking Safety and Relapse Prevention sustained experienced greater improvement in substance use and PTSD symptoms at 6-month and 9-month follow-ups than subjects in the community care group. Seeking Safety and Relapse Prevention are efficacious short-term treatments for low-income urban women with PTSD, substance use disorder, and other psychiatric symptoms.

Length of post-intervention follow-up: 6 months and 9 months.

Morrissey, J. P., Jackson, E. W., Ellis, A. R., Amaro, H., Brown, V. B., & Najavits, L. M. (2005). Twelve-month outcomes of trauma-informed interventions for women with co-occurring disorders. Psychiatric Services, 56, 1213-1222.

Type of Study: Controlled trial
Number of Participants: 2,026 total across all sites (Seeking Safety at four of the nine study sites)

Population:

• Age range — 18 and older
• Race/Ethnicity — 50% Caucasian, 25% African-American, 17% Hispanic, and 7% Other or Mixed.
• Gender — Not Specified
• Status — Women in community treatment with co-occurring mental health and substance use disorders.

Location / Institution: National, multi-site

Summary: (To include comparison groups, outcomes, measures, notable limitations)
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. 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. 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. Outcomes for women with co-occurring disorders and a history of violence and trauma may improve with integrated treatment.

Length of post-intervention follow-up: 12 months.

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

Type of Study: Controlled trial
Number of Participants: 313

Population:

• Age range — 18 or older
• Race/Ethnicity — Seeking Safety condition: 39% Caucasian, 27% Hispanic, 21% African-American, 11% Native American, 2% Biracial, and 0.53% Asian; control condition: 35% Caucasian, 26% Hispanic, 24% African-American, 13% Native American, 1% Biracial, and 1% Asian.
• Gender — Not Specified
• Status — Women in community treatment with substance use disorder, history of trauma, and one or more psychiatric disorders.

Location / Institution: Los Angeles

Summary: (To include comparison groups, outcomes, measures, notable limitations)
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.

Length of post-intervention follow-up: None.

Brown, V. B., Najavits, L. M., Cadiz, S., Finkelstein, N., Heckman, J. P., & Rechberger, E. (2007). Implementing an evidence-based practice: Seeking Safety group. Journal of Psychoactive Drugs, 39, 231-240.

Type of Study: Secondary analysis from controlled trial
Number of Participants: 157 client, 32 clinicians

Population:

• Age range — 18 and older
• Race/Ethnicity — Two sites primarily Caucasian, one site primarily African-American, two sites with significant Hispanic rates.
• Gender — Not Specified
• Status — Women in community treatment with current co-occurring mental health and substance use disorders, and their clinicians.

Location / Institution: Multisite (Los Angeles, Boston, New York City)

Summary: (To include comparison groups, outcomes, measures, notable limitations)
Note: This study uses the same sample from Morrisey et al., above. This paper presents findings from a multi-site study on adopting and implementing Seeking Safety, for women with co-occurring disorders and experiences of physical and sexual abuse. It focused 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 in the Diffusion of Innovations (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. It 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.

Length of post-intervention follow-up: N/A

Desai, R.A., Harpaz-Rotem, I, Najavits, L.M., & Rosenheck, R.A. (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, R. A. et al. (2009). Seeking Safety therapy: Clarification of results.Psychiatric Services, 60, 125.

Type of Study: Controlled trial
Number of Participants: 450

Population:

• Age range — 18 or older
• Race/Ethnicity — Seeking Safety: 46% African-American, 42% Caucasian, 3% Hispanic, and 9% Other and/or multiracial; Control: 53% African-American, 33% Caucasian, 8% Hispanic, and 6% Other and/or multiracial
• Gender — Not Specified
• Status — Homeless woman veterans.

Location / Institution: National, multisite

Summary: (To include comparison groups, outcomes, measures, notable limitations)
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. 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. 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. 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. The correction to this article provides end-of-treatment outcomes (at six months) and major loss during follow-up. 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 2 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.

Length of post-intervention follow-up: 3 months and 6 months.

Zlotnick, C., Johnson, J., & Najavits, N. M. (2009). Randomized controlled pilot study of cognitive-behavioral therapy in a sample of incarcerated women with substance use disorder and PTSD. Behavioral Therapy, 40(4), 325-336.

Type of Study: Randomized controlled trial
Number of Participants: 49

Population:

• Age range — Mean age 34.6 years
• Race/Ethnicity — 47% Caucasian, 33% African American, 14% Hispanic, and 6% Other
• Gender — Female
• Status — Participants were women in a residential substance abuse treatment program in a minimum security prison.

Location / Institution: Location of prison not specified

Summary: (To include comparison groups, outcomes, measures, notable limitations)
The study evaluated the effectiveness of Seeking Safety (SS) in a sample of incarcerated women with substance use disorder (SUD). Participants were randomly assigned to a treatment group or to a treatment as usual (TAU) comparison group. Women were assessed at intake, 12 weeks, and at 3- and 6-month follow-up using the Clinician-Administered Posttraumatic Stress Disorder Scale-I (CAPS-I), Structured Clinical Interview for DSM-IV Patient Version (SCID), Addiction Severity Index (ASI), Time Line Follow Back (TLFB), Brief Symptom Inventory (BSI), Treatment Services Review (TSR), Client Satisfaction Questionnaire (CSQ), End-of-Treatment Questionnaire, Evaluation of Treatment Interview, and the Seeking Safety Adherence Scale. Results indicated that 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. 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.

Length of post-intervention follow-up: 6 months.

Boden, M. T., Kimerling, R., Jacobs-Lentz, J., Bowman, D., Weaver, C., Carney, D., … Trafton, J. A. (2012). Seeking Safety treatment for male veterans with a substance use disorder and PTSD symptomatology. Addiction, 107(3), 578-586.

Type of Study: Randomized controlled trial (block randomized within each of three stratification groups)
Number of Participants: 98

Population:

• Age range — Intervention: mean 55.1 years. Control: mean 52.9 years
• Race/Ethnicity — Intervention: 65.3% African American, 14.3% Caucasian, 8.2% Hispanic, 4.1% Native American, and 4.1% Other. Control: 55.1% African American, 24.5% Caucasian, 6.1% Hispanic, 0.0% Native American, and 6.1% Other.
• Gender — Male
• Status — Male veterans with Veteran's Administration (VA) healthcare eligibility and a diagnosis of any current alcohol or drug use disorder who completed an intake for outpatient substance use treatment at the VA Oakland outpatient mental health clinic and met criteria for current PTSD.

Location / Institution: VA outpatient substance use disorder treatment clinic in Oakland, CA

Summary: (To include comparison groups, outcomes, measures, notable limitations)
This study examines whether substituting Seeking Safety (SS) for part of treatment as usual (TAU) improves substance use outcomes among male military veterans with a substance use disorder and co-occurring PTSD symptomatology.  Measures were administered at the first day of treatment, and three- and six-months following the baseline assessment, and included the Addiction Severity Index (ASI) and the Impact of Events Scale-Revised. Treatment attendance and patient satisfaction (using the Client Satisfaction Questionnaire) were measured following treatment. Active coping was measured using the Coping Responses Inventory at treatment intake and following treatment.  SS compared to TAU was associated with better drug use outcomes, but 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.  Limitations included differences in education levels between the SS and TAU providers and smaller group sizes in the SS condition.

Length of post-intervention follow-up: 3 months.