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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AA020252 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The broad, long-term objective of the current research is to improve treatment outcomes for individuals with comorbid posttraumatic stress disorder (PTSD) and alcohol abuse and dependence (AUD).
The purpose of which is to evaluate changes in both PTSD symptoms and alcohol use and cravings associated with Cognitive Processing Therapy (CPT) or Relapse Prevention (RP) treatment in individuals with PTSD/AUD, along with mediators and moderators of outcomes.
The study will randomize 235 PTSD/AUD participants recruited from the VA and from the community to CPT, RP, or Interactive Voice Response (IVR) assessment only (AO). Those in the AO condition will be re-randomized after the treatment phase to either RP or CPT. Individuals will be assessed pretreatment, immediately post-treatment, 3-, 6-, 9-, and 12-months post-treatment and will monitor symptoms daily throughout treatment.
Prior research has established that PTSD and AUD are frequently comorbid.
Although combined treatments have been developed, they are complex and lengthy with mixed results as to their efficacy. Excellent treatments exist for PTSD or AUD alone, however, it has not been adequately addressed to what extent these treatments are effective in treating comorbid symptom presentations. To address this research gap, the investigators will evaluate two widely accepted treatments for each respective disorder; Cognitive Processing Therapy (CPT) an effective PTSD treatment and Relapse Prevention (RP), a widely used effective AUD treatment.
The investigators will build on our prior work using a daily telephone Interactive Voice Response (IVR) system to test models of self-medication and the sequence of symptom change for both primary and secondary symptom targets associated with each therapy.
Creating a more comprehensive model of symptom change in PTSD and alcohol use with widely used selective treatments is critical in testing theories of PTSD/AUD, evaluating these treatments for use with PTSD/AUD, and implementing these therapies with PTSD/AUD patients in standard clinical practice
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Processing Therapy (CPT) | Active Comparator |
| |
| Relapse Prevention Therapy (RP) | Active Comparator |
| |
| Assessment Only (AO) | No Intervention | AO functions as a benchmark comparison condition. Consists of baseline assessment, daily interactive voice response (IVR) monitoring, and immediate post-test assessment. Not an active treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Processing Therapy (CPT) | Behavioral | CPT is a highly structured course of therapy that focuses primarily on the cognitive restructuring of trauma related beliefs. |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction in PTSD Symptom Severity from baseline to immediately post treatment, baseline to 3 months, baseline to 6 months, baseline to 9 months, and baseline to 12 months; Clinician-Administered PTSD Scale (CAPS) | 12 Months | |
| Reduction in alcohol consumption from baseline to immediately post treatment, baseline to 3 months, baseline to 6 months, baseline to 9 months, and baseline to 12 months; Form-90 (Alcohol Consumption) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety (GAD-7 & OASIS) | Baseline, Immediately post-treatment, 3-, 6-, 9-, 12-months post-treatment | |
| Penn Alcohol Craving Scale (PACS) | Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra Kaysen | Univeristy of Washington | Principal Investigator |
| Tracy Simpson | VA Puget Sound Health Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harborview Center for Sexual Assault and Traumatic Stress | Seattle | Washington | 98104 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36445895 | Derived | Simpson TL, Kaysen DL, Fleming CB, Rhew IC, Jaffe AE, Desai S, Hien DA, Berliner L, Donovan D, Resick PA. Cognitive Processing Therapy or Relapse Prevention for comorbid Posttraumatic Stress Disorder and Alcohol Use Disorder: A randomized clinical trial. PLoS One. 2022 Nov 29;17(11):e0276111. doi: 10.1371/journal.pone.0276111. eCollection 2022. |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D019973 | Alcohol-Related Disorders |
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| ID | Term |
|---|---|
| D055502 | Secondary Prevention |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Relapse Prevention (RP) | Behavioral | RP utilizes high-risk situation assessment/avoidance, drink refusal skills, assertiveness training,cognitive restructuring as well as other approaches to address issues of alcohol use/dependance. |
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| Patient Health Questionnaire Depression Scale (PHQ-9) | Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment |
| VA Puget Sound Health Care (Seattle Campus) |
| Seattle |
| Washington |
| 98108 |
| United States |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |