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

Primary Purpose

Alcohol Use Disorders

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Extended self-help program with guidance
Briefer Self-help program, no guidance
WL: Extended self-help program, choice of guidance intensity
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Extended self-help program with guidance

Briefer Self-help program, no guidance

WL: Extended self-help program, choice of guidance intensity

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Time Line Follow Back
Number of standard drinks during preceding week (using the Time Line Follow Back)
Time Line Follow Back
Days of heavy drinking during preceding week (using the Time Line Follow Back)

Secondary Outcome Measures

Alcohol Use Disorders Identification Test
assessement of alcohol use problems
Alcohol Abstinence Self Efficacy Scale
instrument measuring self-efficacy
Penn Alcohol Craving Scale
instrument measuring craving for alcohol
Montgomery Asberg Depression Rating Scale
instrument measuring depression
Euro-QOL 5 D
instrument measuring quality of life
Generalized Anxiety Disorder-7
instrument measuring anxiety
Trimbos and iMTA questionnaire on cCosts associated with Psychiatric illness (TiC-P)
Instrument measuring health care consumption and cost-effectiveness (Bouwmans et al., 2013
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.
Adult ADHD Self Report Scale (ASRS)
Screening of ADHD symptoms to be used as predictor of treatment outcome
Health-relevant Personality traits from a Five-factor perspective (hp5i)
Screening of personality traits to be used as predictor of treatment outcome
Adverse Events
Brief questionnaire with questions about any negative side effects of the treatment
Treatment Credibility Scale
Brief questionnaire about if the treatment this far is perceived as effective
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

Full Information

First Posted
January 2, 2016
Last Updated
June 23, 2020
Sponsor
Karolinska Institutet
Collaborators
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT02645721
Brief Title
Internet Based Cognitive Behavior Treatment for Alcohol Use Disorders
Acronym
ICBT-AUD
Official Title
Internet Based Cognitive Behavior Treatment for Alcohol Use Disorders - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Göteborg University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extended self-help program with guidance
Arm Type
Experimental
Arm Description
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.
Arm Title
Briefer Self-help program, no guidance
Arm Type
Active Comparator
Arm Description
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.
Arm Title
WL: Extended self-help program, choice of guidance intensity
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Extended self-help program with guidance
Other Intervention Name(s)
ePlus with guidance
Intervention Description
See arm description for Experimental
Intervention Type
Behavioral
Intervention Name(s)
Briefer Self-help program, no guidance
Other Intervention Name(s)
eChange
Intervention Description
See arm description for Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
WL: Extended self-help program, choice of guidance intensity
Other Intervention Name(s)
ePlus with choice of guidance intensity
Intervention Description
See arm description for Waiting list.
Primary Outcome Measure Information:
Title
Time Line Follow Back
Description
Number of standard drinks during preceding week (using the Time Line Follow Back)
Time Frame
Screening; Changes before treatment, Post-treatment (12 weeks); and changes after 3-, 12-, and 24-months post-treatment
Title
Time Line Follow Back
Description
Days of heavy drinking during preceding week (using the Time Line Follow Back)
Time Frame
Screening; Changes before treatment, Post-treatment (12 weeks); and changes after 3-, 12-, and 24-months post-treatment
Secondary Outcome Measure Information:
Title
Alcohol Use Disorders Identification Test
Description
assessement of alcohol use problems
Time Frame
Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Title
Alcohol Abstinence Self Efficacy Scale
Description
instrument measuring self-efficacy
Time Frame
Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Title
Penn Alcohol Craving Scale
Description
instrument measuring craving for alcohol
Time Frame
Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Title
Montgomery Asberg Depression Rating Scale
Description
instrument measuring depression
Time Frame
Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Title
Euro-QOL 5 D
Description
instrument measuring quality of life
Time Frame
Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Title
Generalized Anxiety Disorder-7
Description
instrument measuring anxiety
Time Frame
Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Title
Trimbos and iMTA questionnaire on cCosts associated with Psychiatric illness (TiC-P)
Description
Instrument measuring health care consumption and cost-effectiveness (Bouwmans et al., 2013
Time Frame
Screening, 12 months, 24 months post-treatment
Title
Self-report questionnnaire on satisfaction with internet treatment usability features
Description
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.
Time Frame
Post-treatment (12 weeks after before-treatment measure)
Title
Adult ADHD Self Report Scale (ASRS)
Description
Screening of ADHD symptoms to be used as predictor of treatment outcome
Time Frame
Screening
Title
Health-relevant Personality traits from a Five-factor perspective (hp5i)
Description
Screening of personality traits to be used as predictor of treatment outcome
Time Frame
Screening
Title
Adverse Events
Description
Brief questionnaire with questions about any negative side effects of the treatment
Time Frame
Halfway through treatment (6 weeks after before-treatment measure) and post-treatment (12 weeks after before-treatment measure)
Title
Treatment Credibility Scale
Description
Brief questionnaire about if the treatment this far is perceived as effective
Time Frame
3 weeks after before-treatment measure
Title
SCID- section of Alcohol Use Disorders (adjusted to DSM5)
Description
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
Time Frame
Screening interview, 12 and 24 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne H Berman, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
11364
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Internet Based Cognitive Behavior Treatment for Alcohol Use Disorders

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