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

This study has been completed.
Sponsor:
Collaborators:
VA Puget Sound Health Care System
University of Washington
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier:
NCT00760994
First received: September 25, 2008
Last updated: January 14, 2013
Last verified: January 2013

September 25, 2008
January 14, 2013
January 2009
August 2012   (final data collection date for primary outcome measure)
Alcohol cravings and consumption [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00760994 on ClinicalTrials.gov Archive Site
Post-traumatic stress disorder (PTSD) symptoms [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Reducing Alcohol Use & Post-traumatic Stress Disorder (PTSD) With Cognitive Restructuring & Experiential Acceptance
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Alcoholism
  • Stress Disorders, Post-Traumatic
  • 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 Name: Mindfulness meditation
  • 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 Name: Cognitive-behavioral therapy
  • 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:
    • Plate method
    • Food
    • Nutrition guidelines
    • Diet
  • Experimental: 1
    Experiential acceptance
    Intervention: Behavioral: Experiential acceptance
  • Active Comparator: 2
    Cognitive restructuring
    Intervention: Behavioral: Cognitive restructuring
  • Placebo Comparator: 3
    No-intervention control: Nutrition information
    Intervention: Other: No-intervention control: Nutrition information

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
August 2012
August 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00760994
1 R21 AA 17130-01
Yes
Seattle Institute for Biomedical and Clinical Research
Seattle Institute for Biomedical and Clinical Research
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • VA Puget Sound Health Care System
  • University of Washington
Principal Investigator: Tracy L Simpson, Ph.D. VA Puget Sound Health Care System
Seattle Institute for Biomedical and Clinical Research
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP