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

NCT00760994 | Completed Results DMC

• 2 other identifiers: 1R21AA017130-01R21AA017130
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  5 weeks

Study Arms (3)

1 - Experiential Accepatance

EXPERIMENTAL

Experiential acceptance

Behavioral: Experiential acceptance

2 - Cognitive Restructuring

ACTIVE COMPARATOR

Cognitive restructuring

Behavioral: Cognitive restructuring

3 - Control

PLACEBO COMPARATOR

No-intervention control: Nutrition information

Other: No-intervention control: Nutrition information

Interventions

Experiential acceptance BEHAVIORAL

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).

Also known as: Mindfulness meditation

1 - Experiential Accepatance

Cognitive restructuring BEHAVIORAL

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).

Also known as: Cognitive-behavioral therapy

2 - Cognitive Restructuring

No-intervention control: Nutrition information OTHER

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.

Also known as: Plate method, Food, Nutrition guidelines, Diet

3 - Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• VA Puget Sound Health Care System: collaborator
• University of Washington: collaborator

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

Related Publications (19)

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  PMID: 11964100 BACKGROUND

• Morgenstern J, Longabaugh R. Cognitive-behavioral treatment for alcohol dependence: a review of evidence for its hypothesized mechanisms of action. Addiction. 2000 Oct;95(10):1475-90. doi: 10.1046/j.1360-0443.2000.951014753.x.

  PMID: 11070524 BACKGROUND

• Regier DA, Farmer ME, Rae DS, Locke BZ, Keith SJ, Judd LL, Goodwin FK. Comorbidity of mental disorders with alcohol and other drug abuse. Results from the Epidemiologic Catchment Area (ECA) Study. JAMA. 1990 Nov 21;264(19):2511-8.

  PMID: 2232018 BACKGROUND

• Rubonis AV, Colby SM, Monti PM, Rohsenow DJ, Gulliver SB, Sirota AD. Alcohol cue reactivity and mood induction in male and female alcoholics. J Stud Alcohol. 1994 Jul;55(4):487-94. doi: 10.15288/jsa.1994.55.487.

  PMID: 7934057 BACKGROUND

• Simpson TL. Childhood sexual abuse, PTSD, and the functional roles of alcohol use among women drinkers. Subst Use Misuse. 2003 Jan;38(2):249-70. doi: 10.1081/ja-120017248.

  PMID: 12625430 BACKGROUND

• Tate SR, Brown SA, Unrod M, Ramo DE. Context of relapse for substance-dependent adults with and without comorbid psychiatric disorders. Addict Behav. 2004 Dec;29(9):1707-24. doi: 10.1016/j.addbeh.2004.03.037.

  PMID: 15530716 BACKGROUND

• Eifert, G.H., & Forsyth, J.P. (2005) Acceptance & commitment therapy for anxiety disorders: A practitioner's treatment guide to using mindfulness, acceptance, and values-based behavior change strategies. Oakland, CA: New Harbinger Publications.

  BACKGROUND

• Hayes, S. C., Strosahl, K. D., & Wilson, K. G. (1999). Acceptance and commitment therapy: An experiential approach to behavior change. New York: Guilford Press.

  BACKGROUND

• Kadden, R. M., Carroll, K., Donovan, D., Cooney, N. L., Monti, P., Abrams, D., et al. (1992). Cognitive-behavioral coping skills therapy manual: A clinical research guide for therapists treating individuals with alcohol abuse and dependence (Vol. 3; Project MATCH Monograph, DHHS Publication No 92-1895). Washington, DC: U. S. Government Printing Office.

  BACKGROUND

• Levitt, J. T., Brown, T. A., Orsillo, S. M., & Barlow, D. H. (2004). The effects of acceptance versus suppression of emotion on subjective and psychophysiological response to carbon dioxide challenge in patients with panic disorder. Behavior Therapy, 35, 747-766.

  BACKGROUND

• Sharkansky, E. J., Brief, D. P., Peirce, J. M., Meehan, J. C., & Mannix, L. M. (1999). Substance abuse patients with posttraumatic stress disorder (PTSD): Identifying specific triggers of substance use and their associations with PTSD symptoms. Psychology of Addictive Behaviors, 13, 89-97.

  BACKGROUND

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic; Behavior

Interventions

Mindfulness; Cognitive Restructuring; Cognitive Behavioral Therapy; Food; Nutrition Policy; Diet

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Health Policy; Public Policy; Social Control Policies; Policy; Health Care Economics and Organizations; Nutritional Physiological Phenomena

Limitations and Caveats

Limitations of the present study: 1\. The study had a short follow-up assessment period (5 weeks) \& did not assess all PTSD symptoms. 3\. Asking participants to recall \& report drinking on a daily basis may have enhanced the impacts of interventions.

Results Point of Contact

• Title: Tracy Simpson, Ph.D.
• Organization: VA Puget Sound Health Care System

tracy.simpson@va.gov

206-277-3337

Study Officials

• Tracy L Simpson, Ph.D.

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2008
• First Posted: September 26, 2008
• Study Start: January 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 10, 2020
• Results First Posted: August 10, 2020

Record last verified: 2020-07

Locations

US (1)