Sequence of Symptom Change During AUD or PTSD Treatment for Comorbid PTSD/AUD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2019-01-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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PTSD Alcohol Abuse Alcohol Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive Processing Therapy (CPT)

Group Type ACTIVE_COMPARATOR

Cognitive Processing Therapy (CPT)

Intervention Type BEHAVIORAL

CPT is a highly structured course of therapy that focuses primarily on the cognitive restructuring of trauma related beliefs.

Relapse Prevention Therapy (RP)

Group Type ACTIVE_COMPARATOR

Relapse Prevention (RP)

Intervention Type 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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive Processing Therapy (CPT)

CPT is a highly structured course of therapy that focuses primarily on the cognitive restructuring of trauma related beliefs.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No