Reducing Alcohol Use & Post-traumatic Stress Disorder (PTSD) With Cognitive Restructuring & Experiential Acceptance (COPE)

July 27, 2020 updated by: Seattle Institute for Biomedical and Clinical Research

Reducing Alcohol Use & PTSD w/ Cognitive Restructuring & Experiential Acceptance

The purpose of this study is to determine whether an experiential acceptance therapy intervention is effective in the treatment of alcohol dependency and post-traumatic stress disorder (PTSD) symptoms in individuals who suffer from PTSD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Alcohol dependence (AD) afflicts nearly 14% of the population (Kessler et al., 1994; Kessler et al., 1997; Regier et al., 1990), and has a chronic and relapsing course (Brownell, Marlatt, Litchenstein, & Wilson, 1986). Negative emotional states have consistently been found to maintain alcohol use disorders (AUDs; Cooney, Litt, Morse, Bauer, & Gaupp, 1997; Litt, Cooney, Kadden, & Gaupp, 1990; Rubonis et al., 1994) and increase the risk of relapse following AUD treatment (Cooney et al., 1997). This relationship is particularly robust among individuals with co-morbid psychiatric disorders, such as posttraumatic stress disorder (PTSD; Coffey et al., 2002; Sharkansy, Brief, Peirce, Meehan, & Mannix, 1999; Tate, Brown, Unrod, & Ramo, 2004; Waldrop, Back, Verduin, & Brady, in press). Likewise, alcohol use may be maintained by a desire to facilitate or prolong positive emotional states (Cooper, Frone, Russell, & Mudar, 1992; Simpson, 2003).

Many psychological interventions for AUDs, most notably the majority of cognitive-behavioral treatment (CBT) packages, have thus focused on the development of coping skills to prevent relapse in response to such triggers, and have been demonstrated to be at least moderately effective in promoting abstinence (Miller & Wilbourne, 2002). However, attempts to specify the active ingredients of CBT for AD have been disappointing and most studies examining potential mechanisms of change have failed to find the expected relationships (Longabaugh et al., 2005; Morgenstern & Longabaugh, 2000). The lack of empirical evidence substantiating coping skills as a mechanism of change for CBT (Morgenstern & Longabaugh, 2000) may be due, in part, to the lack of specificity in coping skill interventions. Broadly speaking, two primary foci of coping skill interventions for AUD are 1) increasing cognitive techniques focused on challenging and changing thought patterns, or 2) increasing experiential acceptance by fostering an accepting stance towards internal states, such as through "urge surfing" (Kadden et al., 1992). These two coping skill approaches (cognitive restructuring and experiential acceptance) likely lead to reduced alcohol use through different pathways. Theoretically, experiential acceptance approaches suggest that the mechanism of change in decreasing alcohol use is increased willingness toward internal experience (e.g., emotions, thoughts, sensations), whereas cognitive restructuring approaches suggest that decreased alcohol use results from decreases in negative appraisals brought about by challenging and changing thought patterns. However, this has yet to be systematically evaluated.

Study Type

Interventional

Enrollment (Actual)

80

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, 98108
        • VA Puget Sound Health Care System

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:

  • age at least 18 years
  • current DSM-IV diagnosis of alcohol dependence (AD) with some alcohol use in the last month
  • current DSM-IV diagnosis of post-traumatic stress disorder (PTSD)
  • capacity to provide informed consent
  • English fluency
  • no planned absences that they would be unable to complete 6 weeks of daily monitoring and study sessions
  • access to a telephone
  • desire to decrease or stop alcohol drinking behavior

Exclusion Criteria:

  • a history of delirium tremens
  • seizures, in order to ensure that participants will be medically safe to decrease alcohol use
  • opiate abuse or dependence use or chronic treatment with any opioid- containing medications during the previous month
  • currently taking or planning to start taking either antabuse or naltrexone (due to their pharmacological impact on alcohol cravings and use)
  • exhibits signs or symptoms of alcohol withdrawal at the time of initial consent
  • acutely suicidal with intent/plan or present an imminent danger to others
  • a current psychotic disorder

For ethical reasons and because of the preliminary nature of this study, participants may be in ongoing substance abuse or mental health treatment (MH) or may initiate counseling or medications (other than those noted in exclusion criteria) during the course of the study. Mental health treatment involvement will be used as a covariate if it is related to study dependent variables.

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1 - Experiential Accepatance
Experiential acceptance
Behavioral: Experiential acceptance
The experiential acceptance coping condition will focus on changing one's relationship to one's internal events by learning to remain in contact with negative and positive thoughts and feelings and cravings as they are, without defense or judgment or attempting to cling to them (Eifert & Forsyth, 2005; Hayes, Strosahl, & Wilson, 1999; Kadden et al., 1992; Levitt, Brown, Orsillo, & Barlow, 2004).
Other Names:
  • Mindfulness meditation
ACTIVE_COMPARATOR: 2 - Cognitive Restructuring
Cognitive restructuring
Behavioral: Cognitive restructuring
The cognitive restructuring coping condition will focus on how to change the content and frequency of internal events by changing one's thinking patterns (Kadden et al., 1992).
Other Names:
  • Cognitive-behavioral therapy
PLACEBO_COMPARATOR: 3 - Control
No-intervention control: Nutrition information
Other: No-intervention control: Nutrition information
The no-intervention condition will be taught the plate method, a nutritional servings guideline, which will have no content related to AUD or PTSD, in order to control for time and contact with a research assistant.
Other Names:
  • Diet
  • Food
  • Plate method
  • Nutrition guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Drinks Per Day Assessed Using Daily Interactive Voice Response (IVR)
Time Frame: 5 weeks
After the treatment had been started and for five weeks following the treatment, participants reported their alcohol use on the previous day using the IVR technology. Each participant's data were added and averaged to get the average drinks per day of each treatment group (EA and CR) and control group. The higher the number, the more drinks were consumed per day. Possible minimum value: 0. Possible maximum value: unlimited.
5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Post-Traumatic Stress Disorder (PTSD) Scores Per Day Assessed Using Daily Interactive Voice Response (IVR)
Time Frame: 5 weeks
PTSD scores were collected via the IVR technology after the treatment has been started and for the next five weeks. Participants completed an abbreviated version of PCL-C (PTSD Checklist-Civilian Version) daily. Three re-experiencing symptoms, 2 avoidance symptoms, 3 emotional numbing symptoms, & 4 four hyperarousal symptoms were included. Participants rated each symptom from 0 (not at all) to 8 (all the time). The higher the score, the more intense their PTSD symptoms. The minimum & maximum possible scores were 0 & 96, respectively. Each participant's data were added and averaged to get the average PTSD scores per day of each treatment group (EA and CR) and control group.
5 weeks

Collaborators and Investigators

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

Sponsor

Seattle Institute for Biomedical and Clinical Research

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Washington
VA Puget Sound Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

January 1, 2009

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

September 25, 2008

First Submitted That Met QC Criteria

September 25, 2008

First Posted (ESTIMATE)

September 26, 2008

Study Record Updates

Last Update Posted (ACTUAL)

August 10, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R21AA017130-01 (NIH)
  • R21AA017130 (NIH)

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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