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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01663337
Recruitment Status : Recruiting
First Posted : August 13, 2012
Last Update Posted : December 29, 2016
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Debra Kaysen, University of Washington

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.

Condition or disease Intervention/treatment Phase
PTSD Alcohol Abuse Alcohol Dependence Behavioral: Cognitive Processing Therapy (CPT) Behavioral: Relapse Prevention (RP) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 235 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Anxiety (GAD-7 & OASIS) [ Time Frame: Baseline, Immediately post-treatment, 3-, 6-, 9-, 12-months post-treatment ]
  2. Penn Alcohol Craving Scale (PACS) [ Time Frame: Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment ]
  3. Patient Health Questionnaire Depression Scale (PHQ-9) [ Time Frame: Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01663337

Contact: Debra Kaysen

United States, Washington
Harborview Center for Sexual Assault and Traumatic Stress Recruiting
Seattle, Washington, United States, 98104
Contact: Sruti Desai   
VA Puget Sound Health Care (Seattle Campus) Recruiting
Seattle, Washington, United States, 98108
Contact: Martha Hickey   
Sponsors and Collaborators
University of Washington
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Debra Kaysen Univeristy of Washington
Principal Investigator: Tracy Simpson VA Puget Sound Health Care

Responsible Party: Debra Kaysen, Professor, University of Washington Identifier: NCT01663337     History of Changes
Other Study ID Numbers: 39884
1R01AA020252 ( U.S. NIH Grant/Contract )
First Posted: August 13, 2012    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016

Keywords provided by Debra Kaysen, University of Washington:
Posttraumatic Stress Disorder
Alcohol Abuse
Alcohol Dependance
Relapse Prevention (RP)
Cognitive Processing Therapy (CPT)

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs