Posttraumatic Stress Disorder, Substance Use Disorders
Conditions
Keywords
outcomes assessment, substance use disorders, stress disorders, post-traumatic, screening
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALModified Seeking Safety integrated into std outpatient SUD care
The Seeking Safety treatment involves two (one hour) sessions of manualized group therapy for 12 weeks.
BEHAVIORALStandard outpatient SUD care
Patients assigned to standard care meet twice weekly in Recovery 1 groups, which focuses on building abstinence.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. veteran status and VA healthcare eligibility, 2. a diagnosis of any alcohol or drug use disorder, 3. having completed an intake for outpatient SUD treatment at the VA Oakland outpatient mental health clinic, and 4. meeting criteria for a PTSD diagnosis based on a preliminary screen with the PC-PTSD and subsequent full clinical evaluation using the CAPS
Exclusion criteria
1. current participation in any day or inpatient mental health treatment, 2. any contraindications communicated by that patient's primary clinician, 3. acute psychosis, mania, dementia, or suicidal intent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Alcohol Use (ASI Alcohol Composite Scores) | Administered at baseline and 3 months, 6 months and 12 months post baseline. | 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). |
| ASI Drug Composite Score | 1 year | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Symptoms (IES Total Score) | Administered at 3 months, 6 months and 12 months post enrollment | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Seeking Safety 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.
Modified Seeking Safety integrated into std outpatient SUD care: The Seeking Safety treatment involves two (one hour) sessions of manualized group therapy for 12 weeks. | 49 |
| Usual Care Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment.
Standard outpatient SUD care: Patients assigned to standard care meet twice weekly in Recovery 1 groups, which focuses on building abstinence. | 49 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 7 |
| Overall Study | met exclusion criteria | 5 | 2 |
Baseline characteristics
| Characteristic | Seeking Safety | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 55.30 years STANDARD_DEVIATION 9.38 | 53.01 years STANDARD_DEVIATION 9.96 | 54.13 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment United States | 49 participants | 49 participants | 98 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 49 Participants | 49 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Seeking Safety | ASI Drug Composite Score | 3 months | .057 units on a scale | Standard Deviation 0.062 |
| Seeking Safety | ASI Drug Composite Score | 6 months | .051 units on a scale | Standard Deviation 0.06 |
| Seeking Safety | ASI Drug Composite Score | 12 months | .046 units on a scale | Standard Deviation 0.053 |
| Seeking Safety | ASI Drug Composite Score | Baseline | .089 units on a scale | Standard Deviation 0.08 |
| Usual Care | ASI Drug Composite Score | Baseline | .106 units on a scale | Standard Deviation 0.084 |
| Usual Care | ASI Drug Composite Score | 3 months | .095 units on a scale | Standard Deviation 0.091 |
| Usual Care | ASI Drug Composite Score | 12 months | .066 units on a scale | Standard Deviation 0.062 |
| Usual Care | ASI Drug Composite Score | 6 months | .088 units on a scale | Standard Deviation 0.091 |
p-value: <0.05Mixed Models Analysis
Primary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Seeking Safety | Severity of Alcohol Use (ASI Alcohol Composite Scores) | 6 months | .138 units on a scale | Standard Deviation 0.173 |
| Seeking Safety | Severity of Alcohol Use (ASI Alcohol Composite Scores) | Baseline | .259 units on a scale | Standard Deviation 0.264 |
| Seeking Safety | Severity of Alcohol Use (ASI Alcohol Composite Scores) | 12 months | .149 units on a scale | Standard Deviation 0.168 |
| Seeking Safety | Severity of Alcohol Use (ASI Alcohol Composite Scores) | 3 months | .169 units on a scale | Standard Deviation 0.191 |
| Usual Care | Severity of Alcohol Use (ASI Alcohol Composite Scores) | 12 months | .134 units on a scale | Standard Deviation 0.137 |
| Usual Care | Severity of Alcohol Use (ASI Alcohol Composite Scores) | Baseline | .225 units on a scale | Standard Deviation 0.237 |
| Usual Care | Severity of Alcohol Use (ASI Alcohol Composite Scores) | 6 months | .141 units on a scale | Standard Deviation 0.146 |
| Usual Care | Severity of Alcohol Use (ASI Alcohol Composite Scores) | 3 months | .152 units on a scale | Standard Deviation 0.129 |
Comparison: We investigated treatment condition differences in change of drug and alcohol use over four time-points using generalized linear mixed modeling analyses. A trajectory for each participant was modeled yielding estimates of baseline scores (intercept), slope, and error. Four between-person parameters were estimated: average baseline score for all participants, average slope over time in TAU condition, effect of being in SS on average intercept, effect of being in SS on average slope.p-value: >0.05Mixed Models Analysis
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Seeking Safety | PTSD Symptoms (IES Total Score) | 6 months | 38.90 units on a scale | Standard Deviation 16.72 |
| Seeking Safety | PTSD Symptoms (IES Total Score) | 12 months | 35.26 units on a scale | Standard Deviation 20.44 |
| Seeking Safety | PTSD Symptoms (IES Total Score) | Baseline | 46.76 units on a scale | Standard Deviation 19.49 |
| Seeking Safety | PTSD Symptoms (IES Total Score) | 3 months | 40.80 units on a scale | Standard Deviation 20.86 |
| Usual Care | PTSD Symptoms (IES Total Score) | 3 months | 42.40 units on a scale | Standard Deviation 21.3 |
| Usual Care | PTSD Symptoms (IES Total Score) | 6 months | 36.47 units on a scale | Standard Deviation 16.94 |
| Usual Care | PTSD Symptoms (IES Total Score) | Baseline | 47.66 units on a scale | Standard Deviation 16.26 |
| Usual Care | PTSD Symptoms (IES Total Score) | 12 months | 34.07 units on a scale | Standard Deviation 17.72 |
Comparison: Generalized linear mixed modeling analysisp-value: >0.05Mixed Models Analysis