Sequence of Symptom Change During AUD or PTSD Treatment for Comorbid PTSD/AUD
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|ClinicalTrials.gov Identifier: NCT01663337|
Recruitment Status : Recruiting
First Posted : August 13, 2012
Last Update Posted : December 29, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|PTSD Alcohol Abuse Alcohol Dependence||Behavioral: Cognitive Processing Therapy (CPT) Behavioral: Relapse Prevention (RP)||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||235 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Sequence of Symptom Change During AUD (Alcohol Use or Dependence) or PTSD (Posttraumatic Stress Disorder) Treatment for Comorbid PTSD/AUD|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||November 2018|
|Active Comparator: Cognitive Processing Therapy (CPT)||
Behavioral: Cognitive Processing Therapy (CPT)
CPT is a highly structured course of therapy that focuses primarily on the cognitive restructuring of trauma related beliefs.
|Active Comparator: Relapse Prevention Therapy (RP)||
Behavioral: Relapse Prevention (RP)
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.
No Intervention: Assessment Only (AO)
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
- 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) [ Time Frame: 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) [ Time Frame: 12 months ]
- Anxiety (GAD-7 & OASIS) [ Time Frame: Baseline, Immediately post-treatment, 3-, 6-, 9-, 12-months post-treatment ]
- Penn Alcohol Craving Scale (PACS) [ Time Frame: Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment ]
- Patient Health Questionnaire Depression Scale (PHQ-9) [ Time Frame: Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663337
|Contact: Debra Kaysenfirstname.lastname@example.org|
|United States, Washington|
|Harborview Center for Sexual Assault and Traumatic Stress||Recruiting|
|Seattle, Washington, United States, 98104|
|Contact: Sruti Desai email@example.com|
|VA Puget Sound Health Care (Seattle Campus)||Recruiting|
|Seattle, Washington, United States, 98108|
|Contact: Martha Hickey Martha.Hickey@va.gov|
|Principal Investigator:||Debra Kaysen||Univeristy of Washington|
|Principal Investigator:||Tracy Simpson||VA Puget Sound Health Care|