Internet Based Cognitive Behavior Treatment for Alcohol Use Disorders (ICBT-AUD)

Internet Based Cognitive Behavior Treatment for Alcohol Use Disorders - a Randomized Controlled Trial

The purpose of this study is to determine whether extensive internet based cognitive behavior treatment program with guidance is a more effective method to treat individuals with alcohol use disorders than a briefer cognitive behavior treatment program without guidance.

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorders
• Intervention / Treatment: Behavioral: Extended self-help program with guidance; Behavioral: Briefer Self-help program, no guidance; Behavioral: WL: Extended self-help program, choice of guidance intensity

Detailed Description

Two Internet based programs based on cognitive behavioral therapy and relapse prevention are evaluated among Internet help seekers, and compared to a waiting list. The design is a three armed randomized controlled trial, and outcomes are measured in terms of changes in alcohol consumption (mean consumption/week, number of heavy drinking days/week), problematic alcohol use, self efficacy, craving, as well as depression, anxiety and quality of life. In addition to this, the following instruments will be used as predictors: ASRS (ADHD), Hp5i (personality assessment). TIC-P, an instrument measuring cost effectiveness will also be used. Treatment Credibility and Adverse Events will also be assessed, the former once during the third week of treatment, and the latter once half way through treatment and once after treatment.

Primary hypothesis is that the more extended program with guidance (group 1) is more effective in reducing mean alcohol consumption and number of heavy drinking days compared to the briefer program with no guidance (group 2), as well as compared to a waiting list (group 3). A responder to treatment is defined as a participant drinking less than 9 (women)/ 14(men) glasses per week and no more than 3 (women)/4 (men) glasses per drinking day during that week.

A minimum of 169 participants will be recruited in two phases: first through an online screening and then through a diagnostic telephone assessment, where SCID will be used to diagnose Alcohol Use Disorders and MINI will be used to diagnose other psychiatric diagnoses. The telephone assessment and all guidance will be conducted by licensed psychologists or master students in psychology under supervision by licensed psychologists.

Included participants will be randomized into three groups:

Group 1: All participants in this group will have access to an extended cognitive behavioral treatment program and have access to a guide with basic training in psychotherapy (CBT) who assists and counsels the participant throughout the program.

Group 2: Participants in this group will have access to a briefer cognitive behavior treatment program with no access to a guide.

Group 3: Participants in this group will be placed on a waiting list for 12 weeks. Thereafter, they will be given access to the same extended cognitive behavior treatment program as Group 1; they will also be offered a possibility to choose between three guidance options: Choice 1: guide with intensive support, Choice 2: guide with support only at request, Choice 3: no guide.

Interim analyses will be undertaken in May 2016 by graduate students in Clinical psychology writing their MSc theses.

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 11364
    • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ≥ 18 years
• access to the internet
• consumption of at least 9 (females)/14 (males) glasses of alcohol during the preceding week
• AUDIT ≥ 14 for females, ≥ 16 for men
• have an Alcohol Use Disorder according to the DSM-5 (i.e., at least 2 out of 11 criteria)

Exclusion Criteria:

• insufficient Swedish skills
• reading or writing difficulties, if it is to a degree that it will hamper the treatment
• concurrent other psychological treatment with a content resembling treatments in this study
• severe depression defined as a score of more than 30 on the MADRS-S
• suicide-risk defined as more than 4 points on the MADRS-S question 9, or based on the structured interview
• Drug use problems defined as ≥ 8 p on the DUDIT
• somatic or psychiatric disorders that are contraindicated for the treatment or impairs the ability to receive it (for example schizophrenia, bipolar disease, PTSD)
• has during the last 3 weeks begun medication for alcohol problems or other psychiatric disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extended self-help program with guidance; The program is a comprehensive CBT program lasting 12 weeks, with as many modules. The modules are quite extensive. A guide with basic education in psychotherapy assists and counsels participants online.	Behavioral: Extended self-help program with guidance; See arm description for Experimental; Other Names: ePlus with guidance
Active Comparator: Briefer Self-help program, no guidance; This self-help program also lasts 12 weeks but contains only 9 modules; a pause occurs during the final weeks of the program for self-testing of acquired skills. The modules are quite brief. Participants receive no guidance.	Behavioral: Briefer Self-help program, no guidance; See arm description for Active Comparator; Other Names: eChange
Other: WL: Extended self-help program, choice of guidance intensity; Participants will be put on a waiting list. After 12 weeks on the waiting list, participants will receive access the the extended self-help program used in the experimental arm. However, participants will be offered a choice between three guidance options of varying intensity: proactive guidance, reactive guidance (only at participant request) or no guidance.	Behavioral: WL: Extended self-help program, choice of guidance intensity; See arm description for Waiting list.; Other Names: ePlus with choice of guidance intensity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Line Follow Back	Number of standard drinks during preceding week (using the Time Line Follow Back)	Screening; Changes before treatment, Post-treatment (12 weeks); and changes after 3-, 12-, and 24-months post-treatment
Time Line Follow Back	Days of heavy drinking during preceding week (using the Time Line Follow Back)	Screening; Changes before treatment, Post-treatment (12 weeks); and changes after 3-, 12-, and 24-months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Use Disorders Identification Test	assessement of alcohol use problems	Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Alcohol Abstinence Self Efficacy Scale	instrument measuring self-efficacy	Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Penn Alcohol Craving Scale	instrument measuring craving for alcohol	Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Montgomery Asberg Depression Rating Scale	instrument measuring depression	Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Euro-QOL 5 D	instrument measuring quality of life	Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Generalized Anxiety Disorder-7	instrument measuring anxiety	Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Trimbos and iMTA questionnaire on cCosts associated with Psychiatric illness (TiC-P)	Instrument measuring health care consumption and cost-effectiveness (Bouwmans et al., 2013	Screening, 12 months, 24 months post-treatment
Self-report questionnnaire on satisfaction with internet treatment usability features	This instrument contains 40 questions about satisfaction with various features of the internet-based treatment. Results will be analyzed on an aggregated group level. The questionnaire was constructed by the Internet psychiatry clinic in Stockholm.	Post-treatment (12 weeks after before-treatment measure)
Adult ADHD Self Report Scale (ASRS)	Screening of ADHD symptoms to be used as predictor of treatment outcome	Screening
Health-relevant Personality traits from a Five-factor perspective (hp5i)	Screening of personality traits to be used as predictor of treatment outcome	Screening
Adverse Events	Brief questionnaire with questions about any negative side effects of the treatment	Halfway through treatment (6 weeks after before-treatment measure) and post-treatment (12 weeks after before-treatment measure)
Treatment Credibility Scale	Brief questionnaire about if the treatment this far is perceived as effective	3 weeks after before-treatment measure
SCID- section of Alcohol Use Disorders (adjusted to DSM5)	Diagnostic interview via telephone, diagnostic criteria of Alcohol Use Disorders (this will be undertaken if resurces allow). This will be a masked assessment, the interviewer will not know which original group the participant was randomized to	Screening interview, 12 and 24 months post-treatment

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Göteborg University
• Investigators: Principal Investigator: Anne H Berman, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: January 2, 2016
• First Submitted That Met QC Criteria: January 2, 2016
• First Posted (Estimate): January 5, 2016

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism
• Other Study ID Numbers: 2015/2014-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED