Reducing Alcohol Use & Post-traumatic Stress Disorder (PTSD) With Cognitive Restructuring & Experiential Acceptance (COPE)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Alcoholism Stress Disorders, Post-Traumatic |
Behavioral: Experiential acceptance Behavioral: Cognitive restructuring Other: No-intervention control: Nutrition information |
| 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: | Reducing Alcohol Use & PTSD w/ Cognitive Restructuring & Experiential Acceptance |
- Alcohol cravings and consumption [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Post-traumatic stress disorder (PTSD) symptoms [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 133 |
| Study Start Date: | January 2009 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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 Name: Mindfulness meditation
|
|
Active Comparator: 2
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 Name: Cognitive-behavioral therapy
|
|
Placebo Comparator: 3
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:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Washington | |
| VA Puget Sound Health Care System | |
| Seattle, Washington, United States, 98108 | |
| Principal Investigator: | Tracy L Simpson, Ph.D. | VA Puget Sound Health Care System |
More Information
Publications:
| Responsible Party: | Seattle Institute for Biomedical and Clinical Research |
| ClinicalTrials.gov Identifier: | NCT00760994 History of Changes |
| Other Study ID Numbers: | 1 R21 AA 17130-01 |
| Study First Received: | September 25, 2008 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Seattle Institute for Biomedical and Clinical Research:
|
Alcohol Alcoholic Alcoholism Post-traumatic stress disorder PTSD Experiential acceptance Mindfulness Meditation |
Meditate Cognitive restructuring Cognitive Behavioral Therapy Treatment Study Intervention |
Additional relevant MeSH terms:
|
Alcohol Drinking Alcoholism Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Drinking Behavior |
Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Anxiety Disorders |
ClinicalTrials.gov processed this record on May 23, 2013