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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seeking Safety | Active Comparator | 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. |
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| Usual Care | Active Comparator | Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Seeking Safety integrated into std outpatient SUD care | Behavioral | The Seeking Safety treatment involves two (one hour) sessions of manualized group therapy for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Administered at 3 months, 6 months and 12 months post enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jodie A. Trafton, PhD | VA Palo Alto Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System | Palo Alto | California | 94304-1290 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17602023 | Result | Weaver CM, Trafton JA, Walser RD, Kimerling RE. Pilot test of seeking safety treatment with male veterans. Psychiatr Serv. 2007 Jul;58(7):1012-3. doi: 10.1176/ps.2007.58.7.1012. No abstract available. | |
| 21923756 | Result | Boden MT, Kimerling R, Jacobs-Lentz J, Bowman D, Weaver C, Carney D, Walser R, Trafton JA. Seeking Safety treatment for male veterans with a substance use disorder and post-traumatic stress disorder symptomatology. Addiction. 2012 Mar;107(3):578-86. doi: 10.1111/j.1360-0443.2011.03658.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | units on a scale | Administered at baseline and 3 months, 6 months and 12 months post baseline. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jodie Trafton, Director Program Evaluation and Resource Center | Office of Mental Health Operation, Veterans Health Administration | 650-493-5000 | 22474 | Jodie.Trafton@va.gov |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| Standard outpatient SUD care | Behavioral | Patients assigned to standard care meet twice weekly in "Recovery 1" groups, which focuses on building abstinence. |
|
| 22115887 | Result | Oliva EM, Harris AH, Trafton JA, Gordon AJ. Receipt of opioid agonist treatment in the Veterans Health Administration: facility and patient factors. Drug Alcohol Depend. 2012 May 1;122(3):241-6. doi: 10.1016/j.drugalcdep.2011.10.004. Epub 2011 Nov 23. |
| 24073081 | Result | Midboe AM, Cucciare MA, Trafton JA, Ketroser N, Chardos JF. Implementing motivational interviewing in primary care: the role of provider characteristics. Transl Behav Med. 2011 Dec;1(4):588-94. doi: 10.1007/s13142-011-0080-9. |
| 22549276 | Result | Harris AH, Oliva E, Bowe T, Humphreys KN, Kivlahan DR, Trafton JA. Pharmacotherapy of alcohol use disorders by the Veterans Health Administration: patterns of receipt and persistence. Psychiatr Serv. 2012 Jul;63(7):679-85. doi: 10.1176/appi.ps.201000553. |
| 24854218 | Result | Tyler Boden M, Kimerling R, Kulkarni M, Bonn-Miller MO, Weaver C, Trafton J. Coping among military veterans with PTSD in substance use disorder treatment. J Subst Abuse Treat. 2014 Aug;47(2):160-7. doi: 10.1016/j.jsat.2014.03.006. Epub 2014 Apr 13. |
| 27480546 | Result | Zimmerman L, Lounsbury DW, Rosen CS, Kimerling R, Trafton JA, Lindley SE. Participatory System Dynamics Modeling: Increasing Stakeholder Engagement and Precision to Improve Implementation Planning in Systems. Adm Policy Ment Health. 2016 Nov;43(6):834-849. doi: 10.1007/s10488-016-0754-1. |
| 28714721 | Result | Kearney LK, Smith C, Kivlahan DR, Gresen RC, Moran E, Schohn M, Trafton J, Zeiss AM. Mental health productivity monitoring in the Veterans Health Administration: Challenges and lessons learned. Psychol Serv. 2018 Nov;15(4):486-495. doi: 10.1037/ser0000173. Epub 2017 Jul 17. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | 1 year |
|
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|
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| 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) | Posted | Mean | Standard Deviation | units on a scale | Administered at 3 months, 6 months and 12 months post enrollment |
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| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | 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. | 0 | 49 | 0 | 49 |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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