Sequence of Symptom Change During AUD or PTSD Treatment for Comorbid PTSD/AUD
2 other identifiers
interventional
235
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2013
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2012
CompletedFirst Posted
Study publicly available on registry
August 13, 2012
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedJuly 18, 2018
July 1, 2018
5.5 years
August 2, 2012
July 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (3)
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
Patient Health Questionnaire Depression Scale (PHQ-9)
Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment
Study Arms (3)
Cognitive Processing Therapy (CPT)
ACTIVE COMPARATORRelapse Prevention Therapy (RP)
ACTIVE COMPARATORAssessment Only (AO)
NO INTERVENTIONAO 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
Interventions
CPT is a highly structured course of therapy that focuses primarily on the cognitive restructuring of trauma related beliefs.
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.
Eligibility Criteria
You may qualify if:
- Men and women age ≥ 18 years with a current DSM-V diagnosis of alcohol abuse/dependence
- Recent alcohol consumption for at least 2 weeks in the past 30 day period OR at least 2 days of heavy drinking in the past 30 day period
- Desire to abstain from alcohol
- Current DSM-V (Diagnostic and Statistical Manual of Mental Disorders) diagnosis of PTSD
- Capacity to provide informed consent
- English fluency
You may not qualify if:
- Men and women with an unstable psychiatric medication regimen
- Current trauma-focused mental health treatment (MH) or behaviorally focused alcohol dependence (AD) AD/MH treatment in the past 30 days
- Suicide attempt or suicidal ideation with intent or plan, or self-harm in the past month
- Presence of a psychotic disorder or uncontrolled Bipolar Disorder
- Signs or symptoms of alcohol withdrawal at the time of initial consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Harborview Center for Sexual Assault and Traumatic Stress
Seattle, Washington, 98104, United States
VA Puget Sound Health Care (Seattle Campus)
Seattle, Washington, 98108, United States
Related Publications (1)
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.
PMID: 36445895DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Debra Kaysen
Univeristy of Washington
- PRINCIPAL INVESTIGATOR
Tracy Simpson
VA Puget Sound Health Care
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 2, 2012
First Posted
August 13, 2012
Study Start
March 1, 2013
Primary Completion
September 1, 2018
Study Completion
January 1, 2019
Last Updated
July 18, 2018
Record last verified: 2018-07