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

This study is currently recruiting participants.
Verified March 2013 by University of Washington
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Debra Kaysen, University of Washington
ClinicalTrials.gov Identifier:
NCT01663337
First received: August 2, 2012
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
PTSD
Alcohol Abuse
Alcohol Dependence
 Behavioral: Cognitive Processing Therapy (CPT)
Behavioral: Relapse Prevention (RP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anxiety (GAD-7 & OASIS) [ Time Frame: Baseline, Immediately post-treatment, 3-, 6-, 9-, 12-months post-treatment ] [ Designated as safety issue: No ]
  • Penn Alcohol Craving Scale (PACS) [ Time Frame: Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment ] [ Designated as safety issue: No ]
  • Patient Health Questionnaire Depression Scale (PHQ-9) [ Time Frame: Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 235
Study Start Date: March 2013
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 diagnosis of PTSD
  • Capacity to provide informed consent
  • English fluency

Exclusion Criteria:

  • Men and women with an unstable psychiatric medication regimen
  • A current diagnosis of opioid dependence or abuse
  • Current trauma-focused mental health treatment (MH) or behaviorally focused 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663337

Contacts
Contact: Debra Kaysen dkaysen@u.washington.edu

Locations
United States, Washington
VA Puget Sound Health Care (Seattle Campus) Not yet recruiting
Seattle, Washington, United States
Contact: Tracy Simpson         Tracy.Simpson@va.gov    
Harborview Center for Sexual Assault and Traumatic Stress Recruiting
Seattle, Washington, United States, 98104
Contact: Lucy Berliner, Ph.D         lucyb@uw.edu    
Sponsors and Collaborators
University of Washington
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
  More Information

No publications provided

Responsible Party: Debra Kaysen, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01663337     History of Changes
Other Study ID Numbers: 39884, 1R01AA020252
Study First Received: August 2, 2012
Last Updated: March 6, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Washington:
Posttraumatic Stress Disorder
PTSD
Alcohol Abuse
Alcohol Dependance
 Alcoholism
Comorbid
Relapse Prevention (RP)
Cognitive Processing Therapy (CPT)

Additional relevant MeSH terms:
Alcoholism
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Alcohol-Related Disorders
 Substance-Related Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on May 22, 2013