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

Study Overview
=================
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.

Official Title
-----------------
Reducing Alcohol Use & PTSD w/ Cognitive Restructuring & Experiential Acceptance

Conditions
-----------------
Alcoholism, Stress Disorders, Post-Traumatic

Intervention / Treatment
-----------------
* Behavioral: Experiential acceptance
* Behavioral: Cognitive restructuring
* Other: No-intervention control: Nutrition information


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 - Experiential Accepatance<br>Experiential acceptance | Behavioral: Experiential acceptance<br>* 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).<br>* Other names: Mindfulness meditation;|
| Active Comparator: 2 - Cognitive Restructuring<br>Cognitive restructuring | Behavioral: Cognitive restructuring<br>* 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).<br>* Other names: Cognitive-behavioral therapy;|
| Placebo Comparator: 3 - Control<br>No-intervention control: Nutrition information | Other: No-intervention control: Nutrition information<br>* 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.<br>* Other names: Diet;|

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) | 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) | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alcohol, Alcoholic, Alcoholism, Post-traumatic stress disorder, PTSD, Experiential acceptance, Mindfulness, Meditation, Meditate, Cognitive restructuring, Cognitive, Behavioral, Therapy, Treatment, Study, Intervention