Quality of Research
Review Date: October 2006
Documents Reviewed
The documents below were reviewed for Quality of Research. The research point of
contact can provide information regarding the studies reviewed and the availability
of additional materials, including those from more recent studies that may have been conducted.
Study 1Hien, D. A., Cohen, L. R., Miele, G. M., Litt, L. C., & Capstick, C. (2004). Promising treatments for women with comorbid PTSD and substance use disorders. American Journal of Psychiatry, 161, 1426-1432.  Study 2Holdcraft, 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. Study 3Morrissey, 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. Study 4Najavits, L. M., Gallop, R. J., & Weiss, R. D. (2006). Seeking Safety therapy for adolescent girls with PTSD and substance use disorder: A randomized controlled trial. Journal of Behavioral Health Services and Research, 33, 453-463. Study 5Najavits, L. M., Schmitz, M., Gotthardt, S., & Weiss, R. D. (2005). Seeking Safety plus exposure therapy: An outcome study on dual diagnosis men. Journal of Psychoactive Drugs, 37, 425-435. Study 6Najavits, L. M., Weiss, R. D., Shaw, S. R., & Muenz, L. R. (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. Study 7Weller, L. A. (2005). Group therapy to treat substance use and traumatic symptoms in female veterans. Federal Practitioner, 27-38. Study 8Zlotnick, C., Najavits, L. M., Rohsenow, D. J., & Johnson, D. M. (2003). A cognitive-behavioral treatment for incarcerated women with substance abuse disorder and posttraumatic stress disorder: Findings from a pilot study. Journal of Substance Abuse Treatment, 25, 99-105.
Supplementary Materials 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.
Najavits, L. M. (2002). Seeking Safety: A treatment manual for PTSD and substance abuse. New York: Guilford Press.
Poster of the Safe Coping Skills
Seeking Safety Adherence Scale and Score Sheet
Video Training Series on Seeking Safety
Outcomes
| Outcome 1: Substance use |
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Description of Measures
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Substance use was indicated by urinalysis. Some studies used the Substance Use Inventory, a self-report of quantity and frequency over the past week. Outcomes were based on mean rating of use over previous 4 weeks. One study used the Clinical Global Impression (CGI), a 7-point interviewer-rated scale characterizing abuse severity and improvement. Some studies used the Addiction Severity Index (ASI) self-report of problem severity in last 30 days. One study with adolescent girls used the Personal Experiences Inventory.
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Key Findings
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A randomized controlled trial of 107 women assessed the severity of substance use in participants assigned to Seeking Safety, Relapse Prevention, or a usual care control condition. Compared with women in the usual care control condition, women who participated in Seeking Safety significantly reduced their substance use at the end of treatment (p < .001) and at the 6-month follow-up (p < .05).
In a randomized controlled trial with 33 adolescent girls, Seeking Safety participants significantly improved on 7 of 10 Personal Experience Inventory subscales compared with participants who received usual care (p < .05), with effect sizes that ranged from small (Cohen's d = 0.37) to large (Cohen's d = 1.17). At the 3-month follow-up assessment, Seeking Safety participants continued to show a significant improvement on the Loss of Control subscale (p < .05), with a small effect size (Cohen's d = 0.37).
In five studies with small samples and no control groups, Seeking Safety participants showed pre- to posttreatment reductions in substance use (p < .05). In one of the five studies, Seeking Safety participants significantly increased their substance abstinence (p < .008). In another study, weekly urinalyses suggested that three of five participants were abstinent throughout treatment. In a study of incarcerated women, 11 of 17 participants in the Seeking Safety program did not report using drugs 3 months after release.
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Studies Measuring Outcome
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Study 1, Study 2, Study 3, Study 4, Study 5, Study 6, Study 7, Study 8
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Study Designs
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Experimental, Preexperimental
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Quality of Research Rating
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2.1
(0.0-4.0 scale)
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| Outcome 2: Trauma-related symptoms |
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Description of Measures
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In some studies, trauma-related symptoms were measured using the Clinician-Administered Post Traumatic Stress Disorder Scale, a structured clinical interview that assesses frequency, intensity, severity of DSM-IV PTSD symptoms and impact of symptoms on social and occupational functioning. The Impact of Event Scale, a 15-item self-report of symptoms of intrusion and avoidance, was used for some research. Other studies used the Posttraumatic Symptom Scale (PSS), a 17-item self-report that indicates frequency of problems following a traumatic event. Some studies used the Trauma Symptom Checklist 40, a self-report measure. The Clinician-Administered PTSD Scale was used to determine lifetime and current diagnosis of PTSD, and intensity and severity of symptoms in the last month for some studies. The World Assumptions Scale, a measure of cognitions related to PTSD, was also used.
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Key Findings
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In a study that randomly assigned 107 women to Seeking Safety, Relapse Prevention, or a usual care control condition, the Seeking Safety participants showed a significant improvement on measures of trauma symptoms compared with usual care participants at the end of treatment (p < .01), at the 6-month follow-up (p < .05), and at the 9-month follow-up (p < .05).
Among those participants with severe baseline trauma-related symptoms, 30% of Seeking Safety participants experienced a moderately improved to a better level of functioning at the 12-month follow-up compared with their baseline pretreatment assessment. By contrast, only 21% of the participants in the usual care control group experienced an improvement in trauma-related symptoms at the 12-month follow-up. Thoughts related to PTSD also decreased in the Seeking Safety participants compared with the usual care participants.
In a randomized controlled trial with a sample of 33 adolescent girls, those in Seeking Safety had fewer sexual concerns (p = .002) and less sexual distress (p < .001) 2 months after intake compared with the girls in the usual care control condition.
In a study of incarcerated women, 9 of 17 participants in Seeking Safety no longer met the diagnostic criteria for PTSD at the end of treatment. The Seeking Safety sample as a whole showed significant decreases in PTSD symptoms from pre- to posttreatment (p = .002) and from pretreatment to 3 months after release (p = .04).
A pilot study of 17 women exposed to Seeking Safety also showed decreases in trauma-related symptoms from pre- to posttreatment (p < .05).
In three additional studies with small samples and no control groups, Seeking Safety participants showed a pre- to posttreatment reduction in PTSD symptoms. In a study of veterans exposed to the Seeking Safety program, PTSD symptoms on the PTSD Checklist decreased significantly from pre- to posttreatment. This study on male veterans who participated in Seeking Safety also showed significant decreases in trauma-related symptoms.
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Studies Measuring Outcome
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Study 1, Study 3, Study 4, Study 5, Study 6, Study 8
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Study Designs
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Experimental, Preexperimental
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Quality of Research Rating
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2.3
(0.0-4.0 scale)
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| Outcome 3: Psychopathology |
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Description of Measures
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In some studies, psychopathology was measured by the Global Assessment Scale of overall psychiatric functioning and impairment in the last 4 weeks. Some studies used the Brief Symptom Inventory (BSI) of general psychiatric symptoms. One study used psychiatric hospitalizations as well as responses to the Suicidal Behaviors Questionnaire as indications of psychopathology. Some studies assessed depression with the Hamilton Depression Rating Scale or the Beck Depression Inventory II. Adolescents were assessed with the Adolescent Psychopathology Scale (APS), 346 items on DSM disorders and psychosocial problems.
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Key Findings
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In a study that randomly assigned 107 women to Seeking Safety, Relapse Prevention, or a usual care control condition, Seeking Safety participants improved on measures of psychopathology from pre- to posttreatment (p < .01), whereas participants in the control condition worsened. At the 6- and 9-month follow-up assessments, Seeking Safety participants continued to show better functioning, but the difference was not statistically significant.
In a study examining 12-month follow-up outcomes for women in Seeking Safety or treatment as usual, those in Seeking Safety improved more (p < .001), with a small effect size (Cohen's d = 0.18).
In a randomized controlled trial of 33 adolescent girls, those in Seeking Safety showed greater improvement in their symptoms of anorexia, somatization, and major depression compared with the girls in the usual care control group. The effect sizes for anorexia (Cohen's d = 2.02) and somatization (Cohen's d = 1.27) were large, while the effect size for major depression (Cohen's d = 0.40) was small.
A variety of improvements were found for Seeking Safety participants in three pilot studies. A sample of five dually diagnosed men improved pre- to posttreatment on the Global Assessment of Functioning (p < .02). A sample of women in a community mental health program showed pre- to posttreatment improvements in clinicians' ratings of psychiatric functioning (p < .01). In a pilot study of Seeking Safety, 17 women showed pre- to posttreatment reductions in suicidal thoughts and risk for future suicide.
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Studies Measuring Outcome
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Study 1, Study 2, Study 3, Study 4, Study 5, Study 6, Study 7
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Study Designs
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Experimental, Preexperimental
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Quality of Research Rating
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2.1
(0.0-4.0 scale)
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| Outcome 4: Treatment retention |
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Description of Measures
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Treatment retention was measured by clinicians' records.
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Key Findings
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In a study of dually diagnosed men, all 5 participants completed 30 of 30 Seeking Safety sessions. In a pilot study of Seeking Safety, 17 of 27 women completed treatment (attended 6 or more sessions). In a study of adolescent girls, the average attendance was 11.78 of 25 sessions.
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Studies Measuring Outcome
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Study 4, Study 5, Study 6
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Study Designs
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Experimental, Preexperimental
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Quality of Research Rating
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2.2
(0.0-4.0 scale)
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Study Populations
The following populations were identified in the studies reviewed for Quality of
Research.
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Study
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Age
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Gender
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Race/Ethnicity
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Study 1
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18-25 (Young adult)
26-55 (Adult)
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100% Female
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42.1% Black or African American
37.4% White
19.6% Hispanic or Latino
0.9% Race/ethnicity unspecified
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Study 2
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18-25 (Young adult)
26-55 (Adult)
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100% Female
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80% White
15% Black or African American
5% Asian
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Study 3
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26-55 (Adult)
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100% Female
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50% White
25% Black or African American
17% Hispanic or Latino
7% Race/ethnicity unspecified
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Study 4
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13-17 (Adolescent)
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100% Female
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78.8% White
12.1% Asian
3% Black or African American
3% Hispanic or Latino
3% Race/ethnicity unspecified
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Study 5
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26-55 (Adult)
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100% Male
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100% White
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Study 6
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26-55 (Adult)
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100% Female
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88.2% White
11.8% Black or African American
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Study 7
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26-55 (Adult)
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100% Female
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83.3% White
16.7% American Indian or Alaska Native
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Study 8
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26-55 (Adult)
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100% Female
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66.7% White
16.7% Race/ethnicity unspecified
11.1% Black or African American
5.6% Hispanic or Latino
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Quality of Research Ratings by Criteria (0.0-4.0 scale)
External reviewers independently evaluate the Quality of Research for an intervention's
reported results using six criteria:
For more information about these criteria and the meaning of the ratings, see Quality of Research.
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Outcome
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Reliability
of Measures
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Validity
of Measures
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Fidelity
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Missing
Data/Attrition
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Confounding
Variables
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Data
Analysis
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Overall
Rating
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1: Substance use
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2.3
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2.3
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2.3
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2.0
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1.6
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2.0
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2.1
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2: Trauma-related symptoms
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2.7
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2.7
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2.9
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2.0
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1.8
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2.1
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2.3
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3: Psychopathology
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2.4
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2.4
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2.1
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2.0
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1.7
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2.1
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2.1
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4: Treatment retention
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2.0
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2.0
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3.4
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2.2
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1.9
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1.9
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2.2
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Study Strengths Findings were consistently positive in a variety of domains. Some studies showed very careful attention to fidelity.
Study Weaknesses Some studies used convenience samples. Sample size was often small, making it difficult to rule out confounds or make statistical inferences.
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Readiness for Dissemination
Review Date: October 2006
Materials Reviewed
The materials below were reviewed for Readiness for Dissemination. The implementation
point of contact can provide information regarding implementation of the intervention
and the availability of additional, updated, or new materials.
Najavits, L. (2000). Training clinicians to conduct the Seeking Safety treatment for PTSD and substance abuse. Alcoholism Treatment Quarterly, 18, 83-98.
Najavits, L. (2002). Seeking Safety: A new psychotherapy for posttraumatic stress disorder and substance use disorder. In P. Ouimette & P. Brown (Eds.), Trauma and substance abuse: Causes, consequences, and treatment of comorbid disorders (pp. 147-170). Washington, DC: American Psychological Association Press.
Najavits, L. (2002). Seeking Safety: A treatment manual for PTSD and substance abuse. New York: Guilford Press.
Najavits, L. (2004). Implementing Seeking Safety therapy for PTSD and substance abuse: Clinical guidelines. Alcoholism Treatment Quarterly, 22(1), 43-62.
Najavits, L. (2005). A client's story: Teaching grounding to a client [VHS].
Najavits, L. (2005). Example of a group session: Asking for help [VHS].
Najavits, L. (2005). Seeking Safety: Therapy for trauma/PTSD and substance abuse [VHS].
Najavits, L. (2005). Session for Adherence Scale rating: Healthy Relationships [VHS].
Najavits, L. (2006). Seeking Safety. In V. Follette & J. Ruzek (Eds.), Cognitive-Behavioral Therapies for Trauma (2nd ed.) (pp. 228-257). New York: Guilford Press.
Seeking Safety Web site, http://www.seekingsafety.org
Readiness for Dissemination Ratings by Criteria (0.0-4.0 scale)
External reviewers independently evaluate the intervention's Readiness for Dissemination
using three criteria:
- Availability of implementation materials
- Availability of training and support resources
- Availability of quality assurance procedures
For more information about these criteria and the meaning of the ratings, see Readiness for Dissemination.
Implementation
Materials
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Training and Support
Resources
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Quality Assurance
Procedures
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Overall
Rating
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4.0
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4.0
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3.9
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4.0
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Dissemination Strengths Implementation materials are intended to be used by clinicians, though the written materials, Web site information, video tapes, and classes could also be useful for trainees. The program Web site provides detailed information on available trainings and discusses available on-site and telephone consultation. An adherence scale is provided to support quality assurance. Intervention adherence is reviewed as part of the offered consultation.
Dissemination Weaknesses Little information on organizational implementation guidance was provided for review. Links are provided on the Web site to direct users to possible ways of measuring outcomes; however, no specific guidance is provided on some universal measures, nor on how to measure outcomes related to the model.
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Costs
The cost information below was provided by the developer. Although this cost information
may have been updated by the developer since the time of review, it may not reflect
the current costs or availability of items (including newly developed or discontinued
items). The implementation point of contact can provide current information and
discuss implementation requirements.
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Item Description
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Cost
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Required by Developer
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Manual
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$46 each
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Yes
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Poster of safe coping skills
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$16 each
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No
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Card deck of safe coping skills
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$16 each
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No
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Training videos
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$250 per set
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No
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1- , 1.5- , or 2-day, on-site training
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About $1,600 per day depending on site needs and trainer selected, plus travel expenses
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No
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Telephone consultation
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About $115 per hour depending on site needs
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No
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Adherence scale
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Free
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No
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Replications
Selected citations are presented below. An asterisk indicates that the document
was reviewed for Quality of Research.
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.
* Hien, D. A., Cohen, L. R., Miele, G. M., Litt, L. C., & Capstick, C. (2004). Promising treatments for women with comorbid PTSD and substance use disorders. American Journal of Psychiatry, 161, 1426-1432.
* 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.
* 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.
* Najavits, L. M., Gallop, R. J., & Weiss, R. D. (2006). Seeking Safety therapy for adolescent girls with PTSD and substance use disorder: A randomized controlled trial. Journal of Behavioral Health Services & Research, 33, 453-463.
* Najavits, L. M., Schmitz, M., Gotthardt, S., & Weiss, R. D. (2005). Seeking Safety plus exposure therapy: An outcome study on dual diagnosis men. Journal of Psychoactive Drugs, 37, 425-435.
* Najavits, L. M., Weiss, R. D., Shaw, S. R., & Muenz, L. R. (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.
* Weller, L. A. (2005). Group therapy to treat substance use and traumatic symptoms in female veterans. Federal Practitioner, 27-38.
* Zlotnick, C., Najavits, L. M., Rohsenow, D. J., & Johnson, D. M. (2003). A cognitive-behavioral treatment for incarcerated women with substance abuse disorder and posttraumatic stress disorder: Findings from a pilot study. Journal of Substance Abuse Treatment, 25, 99-105
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