Clinical trial NCT00760994: Reducing Alcohol Use & Post-traumatic Stress Disorder (PTSD) With Cognitive Restructuring & Experiential Acceptance
Official title: Reducing Alcohol Use & PTSD w/ Cognitive Restructuring & Experiential Acceptance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Seattle Institute for Biomedical and Clinical Research
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: VA Puget Sound Health Care System
name: University of Washington
First posted: 2008-09-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Average Drinks Per Day Assessed Using Daily Interactive Voice Response (IVR)
timeFrame: 5 weeks
Secondary outcomes:
measure: Average Post-Traumatic Stress Disorder (PTSD) Scores Per Day Assessed Using Daily Interactive Voice Response (IVR)
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System
name: Tracy L Simpson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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