Internet Based Cognitive Behavior Treatment for Alcohol Use Disorders

NCT ID: NCT02645721

Last Updated: 2020-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-06-30

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.

Conditions

Alcohol Use Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Extended self-help program with guidance

Intervention Type: BEHAVIORAL

See arm description for Experimental

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.

Group Type: ACTIVE_COMPARATOR

Briefer Self-help program, no guidance

Intervention Type: BEHAVIORAL

See arm description for Active Comparator

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.

Group Type: OTHER

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

Intervention Type: BEHAVIORAL

See arm description for Waiting list.

Interventions

Extended self-help program with guidance

See arm description for Experimental

Intervention Type: BEHAVIORAL

Briefer Self-help program, no guidance

See arm description for Active Comparator

Intervention Type: BEHAVIORAL

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

See arm description for Waiting list.

Intervention Type: BEHAVIORAL

Other Intervention Names

ePlus with guidance; eChange; ePlus with choice of guidance intensity

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Anne H Berman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne H Berman, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institutet

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

2015/2014-31

Identifier Type: -

Identifier Source: org_study_id