Reducing Alcohol Use & Post-traumatic Stress Disorder (PTSD) With Cognitive Restructuring & Experiential Acceptance
NCT ID: NCT00760994
Last Updated: 2020-08-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
80 participants
INTERVENTIONAL
2009-01-31
2012-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Brief Restructuring Intervention Following Trauma Exposure
NCT02808468
Understanding and Testing Recovery Processes for PTSD and Alcohol Use Following Sexual Assault
NCT04124380
Integrated Alcohol Disorder and PTSD Treatment
NCT01601067
Mechanisms of Change, Motivation, and Treatment Outcome in Alcohol Dependence - Posttraumatic Stress Disorder
NCT01409707
Short-Term Exposure for PTSD
NCT02874898
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1 - Experiential Accepatance
Experiential acceptance
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).
2 - Cognitive Restructuring
Cognitive restructuring
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).
3 - Control
No-intervention control: Nutrition information
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
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).
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
VA Puget Sound Health Care System
FED
University of Washington
OTHER
Seattle Institute for Biomedical and Clinical Research
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tracy L Simpson, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VA Puget Sound Health Care System
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Litt MD, Cooney NL, Kadden RM, Gaupp L. Reactivity to alcohol cues and induced moods in alcoholics. Addict Behav. 1990;15(2):137-46. doi: 10.1016/0306-4603(90)90017-r.
Brownell KD, Marlatt GA, Lichtenstein E, Wilson GT. Understanding and preventing relapse. Am Psychol. 1986 Jul;41(7):765-82. doi: 10.1037//0003-066x.41.7.765. No abstract available.
Cooney NL, Litt MD, Morse PA, Bauer LO, Gaupp L. Alcohol cue reactivity, negative-mood reactivity, and relapse in treated alcoholic men. J Abnorm Psychol. 1997 May;106(2):243-50. doi: 10.1037//0021-843x.106.2.243.
Coffey SF, Saladin ME, Drobes DJ, Brady KT, Dansky BS, Kilpatrick DG. Trauma and substance cue reactivity in individuals with comorbid posttraumatic stress disorder and cocaine or alcohol dependence. Drug Alcohol Depend. 2002 Jan 1;65(2):115-27. doi: 10.1016/s0376-8716(01)00157-0.
Cooper ML, Frone MR, Russell M, Mudar P. Drinking to regulate positive and negative emotions: a motivational model of alcohol use. J Pers Soc Psychol. 1995 Nov;69(5):990-1005. doi: 10.1037//0022-3514.69.5.990.
Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes M, Eshleman S, Wittchen HU, Kendler KS. Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States. Results from the National Comorbidity Survey. Arch Gen Psychiatry. 1994 Jan;51(1):8-19. doi: 10.1001/archpsyc.1994.03950010008002.
Kessler RC, Crum RM, Warner LA, Nelson CB, Schulenberg J, Anthony JC. Lifetime co-occurrence of DSM-III-R alcohol abuse and dependence with other psychiatric disorders in the National Comorbidity Survey. Arch Gen Psychiatry. 1997 Apr;54(4):313-21. doi: 10.1001/archpsyc.1997.01830160031005.
Longabaugh R, Donovan DM, Karno MP, McCrady BS, Morgenstern J, Tonigan JS. Active ingredients: how and why evidence-based alcohol behavioral treatment interventions work. Alcohol Clin Exp Res. 2005 Feb;29(2):235-47. doi: 10.1097/01.alc.0000153541.78005.1f.
Miller WR, Wilbourne PL. Mesa Grande: a methodological analysis of clinical trials of treatments for alcohol use disorders. Addiction. 2002 Mar;97(3):265-77. doi: 10.1046/j.1360-0443.2002.00019.x.
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.
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.
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.
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.
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.
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.
Hayes, S. C., Strosahl, K. D., & Wilson, K. G. (1999). Acceptance and commitment therapy: An experiential approach to behavior change. New York: Guilford Press.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Other Identifiers
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.