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

Primary Purpose

Alcoholism, Stress Disorders, Post-Traumatic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experiential acceptance
Cognitive restructuring
No-intervention control: Nutrition information
Sponsored by
Seattle Institute for Biomedical and Clinical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Alcohol, Alcoholic, Alcoholism, Post-traumatic stress disorder, PTSD, Experiential acceptance, Mindfulness, Meditation, Meditate, Cognitive restructuring, Cognitive, Behavioral, Therapy, Treatment, Study, Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Puget Sound Health Care System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

1 - Experiential Accepatance

2 - Cognitive Restructuring

3 - Control

Arm Description

Experiential acceptance

Cognitive restructuring

No-intervention control: Nutrition information

Outcomes

Primary Outcome Measures

Average Drinks Per Day Assessed Using Daily Interactive Voice Response (IVR)
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.

Secondary Outcome Measures

Average Post-Traumatic Stress Disorder (PTSD) Scores Per Day Assessed Using Daily Interactive Voice Response (IVR)
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.

Full Information

First Posted
September 25, 2008
Last Updated
July 27, 2020
Sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), VA Puget Sound Health Care System, University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT00760994
Brief Title
Reducing Alcohol Use & Post-traumatic Stress Disorder (PTSD) With Cognitive Restructuring & Experiential Acceptance
Acronym
COPE
Official Title
Reducing Alcohol Use & PTSD w/ Cognitive Restructuring & Experiential Acceptance
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2009 (Actual)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), VA Puget Sound Health Care System, University of Washington

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Stress Disorders, Post-Traumatic
Keywords
Alcohol, Alcoholic, Alcoholism, Post-traumatic stress disorder, PTSD, Experiential acceptance, Mindfulness, Meditation, Meditate, Cognitive restructuring, Cognitive, Behavioral, Therapy, Treatment, Study, Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 - Experiential Accepatance
Arm Type
Experimental
Arm Description
Experiential acceptance
Arm Title
2 - Cognitive Restructuring
Arm Type
Active Comparator
Arm Description
Cognitive restructuring
Arm Title
3 - Control
Arm Type
Placebo Comparator
Arm Description
No-intervention control: Nutrition information
Intervention Type
Behavioral
Intervention Name(s)
Experiential acceptance
Other Intervention Name(s)
Mindfulness meditation
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive restructuring
Other Intervention Name(s)
Cognitive-behavioral therapy
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
No-intervention control: Nutrition information
Other Intervention Name(s)
Plate method, Food, Nutrition guidelines, Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average Drinks Per Day Assessed Using Daily Interactive Voice Response (IVR)
Description
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.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Average Post-Traumatic Stress Disorder (PTSD) Scores Per Day Assessed Using Daily Interactive Voice Response (IVR)
Description
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.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy L Simpson, Ph.D.
Organizational Affiliation
VA Puget Sound Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2343787
Citation
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9131844
Citation
Cooney NL, Litt MD, Morse PA, Bauer LO, Gaupp L. Alcohol cue reactivity, negative-mood reactivity, and relapse in treated alcoholic men. J Abnorm Psychol. 1997 May;106(2):243-50. doi: 10.1037//0021-843x.106.2.243.
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PubMed Identifier
11772473
Citation
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Reducing Alcohol Use & Post-traumatic Stress Disorder (PTSD) With Cognitive Restructuring & Experiential Acceptance

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