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

July 16, 2018 updated by: Debra Kaysen, University of Washington

Sequence of Symptom Change During AUD (Alcohol Use or Dependence) or PTSD (Posttraumatic Stress Disorder) Treatment for Comorbid PTSD/AUD

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Anticipated)

235

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Center for Sexual Assault and Traumatic Stress
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Health Care (Seattle Campus)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)
Time Frame: 12 Months
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Anxiety (GAD-7 & OASIS)
Time Frame: Baseline, Immediately post-treatment, 3-, 6-, 9-, 12-months post-treatment
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
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
Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Debra Kaysen, Univeristy of Washington
  • Principal Investigator: Tracy Simpson, VA Puget Sound Health Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

August 2, 2012

First Submitted That Met QC Criteria

August 8, 2012

First Posted (Estimate)

August 13, 2012

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 39884
  • 1R01AA020252 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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