Exposure Therapy as Aftercare for Alcohol Use Disorder

NCT02298751 | Completed DMC

• 1 other identifier: Cue Exposure Study, RESCueH
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Background: It is well documented that individuals with Alcohol Use Disorder (AUD) respond well during evidence-based psychological treatment, but also that a large proportion relapse when discharged from treatment and confronted with alcohol in real life. Cue Exposure Therapy (CET) focuses on confronting alcohol cues in order to reduce cravings as well as the likelihood of relapse. The aim of this study is to investigate whether CET as aftercare increases the efficiency of Cognitive Behavioural Therapy (CBT) among AUD individuals. Design and methods: The study is implemented as an investigator-blinded randomized controlled trial. A total of 300 consecutively enrolled AUD patients, recruited from an alcohol outpatient clinic will be randomized to one of the three following aftercare treatment groups: (A) CET as a smartphone application (n = 100); (B) CET as group therapy (n = 100), and (C) Aftercare as Usual (n = 100). It is hypothesized that the two experimental groups ((A) and (B)) will achieve better treatment outcomes as compared to the control group ((C)), and It will be explored whether CET as smartphone application is as effective as CET as group therapy. The groups will be compared in a number of parameters including alcohol intake, cravings and copings-strategies. Discussion: If the hypothesis, that CET increases the efficiency of CBT is verified, it will make sense to supplement CBT with CET as aftercare, hence, reintegrating CET within a CBT approach. Although, CET is most often regarded as one of the behavioral methods in CBT, there appears to be segregation in the empirical literature when it comes to treatment of addictive disorders. However, CET may allow the patient to practice and gain control over alcohol cue reactivity and associated high-risk situations in an inter-mediating therapeutic context before the patients inevitably are confronted by them. In this way, one might expect the transition from treatment to daily life less overwhelming and CET may help prevent relapse in the long term. Thus, CET may be particularly suitable as aftercare.

Conditions

Alcohol Use Disorders

Outcome Measures

Primary Outcomes (1)

• Alcohol consumption

  Abstinence or controlled use of alcohol in the last 30 days 26 weeks after treatment start as measured with the timeline follow-back method

  26 weeks after baseline

Secondary Outcomes (2)

• Alcohol consumption

  8 weeks after baseline

• Alcohol related contact with the Health Care system

  One year after baseline

Other Outcomes (4)

• Cravings as measured by the Visual Analogue Craving Scale, Obsessive-Compulsive Drinking Scale and Desires for Alcohol Questionnaire

  26 weeks after baseline

• Cravings as measured by the Visual Analogue Craving Scale, Obsessive-Compulsive Drinking Scale and Desires for Alcohol Questionnaire

  8 weeks after baseline

• Coping skills as measured by The Urge-Specific Strategies Questionnaire

  26 weeks after baseline

Study Arms (3)

CET via smartphone

EXPERIMENTAL

Cue Exposure Treatment

Behavioral: Cue Exposure Treatment

CET via group sessions

EXPERIMENTAL

Cue Exposure Treatment

Behavioral: Cue Exposure Treatment

Aftercare as usual

NO INTERVENTION

Interventions

Cue Exposure Treatment BEHAVIORAL

CET via group sessions; CET via smartphone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Completed primary treatment with CBT
• Accept participating in the study

You may not qualify if:

• Not Danish speaking
• Psychotic disorders
• Severe cognitive impairment
• Terminal somatic illness

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Unit if Clinical Alcohol Research

Odense, 5000, Denmark

Location

Related Publications (3)

• Stryhn L, Larsen MB, Mejldal A, Sibbersen C, Nielsen DG, Nielsen B, Nielsen AS, Stenager E, Mellentin AI. Relapse prevention for alcohol use disorders: combined acamprosate and cue exposure therapy as aftercare. Nord J Psychiatry. 2022 Jul;76(5):394-402. doi: 10.1080/08039488.2021.1985169. Epub 2021 Oct 8.

  PMID: 34622734 DERIVED

• Mellentin AI, Nielsen B, Nielsen AS, Yu F, Mejldal A, Nielsen DG, Stenager E. A Mobile Phone App Featuring Cue Exposure Therapy As Aftercare for Alcohol Use Disorders: An Investigator-Blinded Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Aug 16;7(8):e13793. doi: 10.2196/13793.

  PMID: 31420960 DERIVED

• Mellentin AI, Nielsen B, Nielsen AS, Yu F, Stenager E. A randomized controlled study of exposure therapy as aftercare for alcohol use disorder: study protocol. BMC Psychiatry. 2016 Apr 21;16:112. doi: 10.1186/s12888-016-0795-8.

  PMID: 27098817 DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 24, 2014
• Study Start: May 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 27, 2021

Record last verified: 2021-10

Locations

DK (1)