An interventional study of Modified Seeking Safety integrated into std outpatient SUD care and Standard outpatient SUD care in Substance Use Disorders and Posttraumatic Stress Disorder, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-07.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research
This study proposes a prospective program of research that will identify feasible and inexpensive methods to detect and treat comorbid PTSD among VA SUD patients, thereby improving substance abuse treatment outcomes.
Background: This study proposes a prospective program of research that will identify feasible and inexpensive methods to detect and treat comorbid PTSD among VA SUD patients, thereby improving substance abuse treatment outcomes.
Objective(s): Our objectives are to test the effectiveness of substituting 2 hours/week of Seeking Safety-based groups for standard substance use focused groups for male patients attending outpatient substance use disorder treatment who meet clinical criteria for PTSD. Primary outcomes measures will assess substance use disorder severity and secondary outcome measures will assess mental health and substance use related problems plus treatment satisfaction. We hypothesize that enhanced SUD treatment that incorporates "Seeking Safety" will improve SUD treatment outcomes for PTSD-SUD patients as compared to outcomes for PTSD-SUD patients receiving treatment as usual. Additionally, we examine two hypothesized models via which "Seeking Safety" may effect substance use outcomes. We examine whether 1) reductions in PTSD symptomatology and 2) improvements in coping strategies used in response to PTSD symptoms (reductions in using to cope and other avoidance coping strategies) partially mediate the effect of treatment on substance use outcomes.
Methods: This is a randomized clinical trial of 210 male veterans with PTSD and substance use disorders attending outpatient substance use disorder treatment at the VA Oakland mental health center. Patients will be randomized to 3 months of outpatient substance abuse treatment including either 2 hours/week of "Seeking Safety" or standard addiction focused group therapy. Data will be collected in patient interviews at treatment entry and at 3, 6 and 12 months after treatment initiation and by medical record review. Substance use, PTSD symptomatology, mental health, social functioning, legal problems, use of coping techniques, and treatment satisfaction outcomes will be assessed at treatment entry and 3, 6 and 12 months later using well-validated survey instruments. Primary and secondary treatment outcomes of patients in "Seeking Safety" versus treatment as usual will be compared by repeated measures ANCOVA. We will test the mediational hypotheses according to the 4-step method described by Baron and Kenny (1986).
Status: Project began in January, 2006; Recruitment, treatment and assessment is complete and primary trial finds are published. Secondary analysis is ongoing.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 117 is close to the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
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Exclusion Criteria:
Seeking Safety is a manualized, empirically supported, cognitive behavioral therapy that treats substance use disorders and comorbid PTSD. Participants assigned to the Seeking Safety arm attend two one hour sessions of group therapy for 12 weeks.
Behavioral: Modified Seeking Safety integrated into std outpatient SUD care
Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment.
Behavioral: Standard outpatient SUD care
The Seeking Safety treatment involves two (one hour) sessions of manualized group therapy for 12 weeks.
Also known as: Seeking Safety
Patients assigned to standard care meet twice weekly in "Recovery 1" groups, which focuses on building abstinence.
Severity of Alcohol Use (ASI Alcohol Composite Scores)
Alcohol and drug use composite scores were separately analyzed. The ASI alcohol composite score measures the severity of substance use and amount of use in the past 30 days and consequences of use. Scored as values between 0 and 1 with higher values indicating more severe substance use (i.e. lower values indicate a better outcome).
Time frame: Administered at baseline and 3 months, 6 months and 12 months post baseline.
ASI Drug Composite Score
Addiction Severity Index (ASI) drug composite scores measure past 30 days substance use (McLellan et al., 1992). The ASI assesses lifetime and current use of all major classes of drugs of abuse, history of substance-related problems, and history of SUD treatment. Scored as values between 0 and 1 with higher values indicating more severe substance use (i.e. lower values indicate a better outcome).
Time frame: 1 year
PTSD Symptoms (IES Total Score)
Composite measures of PTSD symptoms. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total score ranging from 0 (not at all) to 88 (extremely)
Time frame: Administered at 3 months, 6 months and 12 months post enrollment
| Milestone | Seeking Safety | Usual Care |
|---|---|---|
| Started | 59 | 58 |
| Completed | 49 | 49 |
| Not completed | 10 | 9 |
| Withdrew: Lost to follow-up | 5 | 7 |
| Withdrew: Met exclusion criteria | 5 | 2 |
Alcohol and drug use composite scores were separately analyzed. The ASI alcohol composite score measures the severity of substance use and amount of use in the past 30 days and consequences of use. Scored as values between 0 and 1 with higher values indicating more severe substance use (i.e. lower values indicate a better outcome).
| units on a scale | Seeking Safety | Usual Care |
|---|---|---|
| Baseline | .259 ± .264 | .225 ± .237 |
| 3 months | .169 ± .191 | .152 ± .129 |
| 6 months | .138 ± .173 | .141 ± .146 |
| 12 months | .149 ± .168 | .134 ± .137 |
Addiction Severity Index (ASI) drug composite scores measure past 30 days substance use (McLellan et al., 1992). The ASI assesses lifetime and current use of all major classes of drugs of abuse, history of substance-related problems, and history of SUD treatment. Scored as values between 0 and 1 with higher values indicating more severe substance use (i.e. lower values indicate a better outcome).
| units on a scale | Seeking Safety | Usual Care |
|---|---|---|
| Baseline | .089 ± .080 | .106 ± .084 |
| 3 months | .057 ± .062 | .095 ± .091 |
| 6 months | .051 ± .060 | .088 ± .091 |
| 12 months | .046 ± .053 | .066 ± .062 |
Composite measures of PTSD symptoms. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total score ranging from 0 (not at all) to 88 (extremely)
| units on a scale | Seeking Safety | Usual Care |
|---|---|---|
| Baseline | 46.76 ± 19.49 | 47.66 ± 16.26 |
| 3 months | 40.80 ± 20.86 | 42.40 ± 21.30 |
| 6 months | 38.90 ± 16.72 | 36.47 ± 16.94 |
| 12 months | 35.26 ± 20.44 | 34.07 ± 17.72 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Seeking Safety | — | 0/49 (0%) | 0/49 (0%) |
| Usual Care | — | 0/49 (0%) | 0/49 (0%) |
| Age, Continuous(years) | Seeking Safety | Usual Care | Total |
|---|---|---|---|
| Mean | 55.30 ± 9.38 | 53.01 ± 9.96 | 54.13 ± 9.70 |
| Sex: Female, Male(Participants) | Seeking Safety | Usual Care | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 49 | 49 | 98 |
| Region of Enrollment(participants) | Seeking Safety | Usual Care | Total |
|---|---|---|---|
| United States | 49 | 49 | 98 |
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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