NCT02014779

Brief Summary

Objectives: This study will evaluate the efficacy of internet-based relapse prevention with therapist support, as compared to face-to-face therapy at an employee assistance program. The design is a two-armed randomized controlled design, and outcomes are measured in terms of changes in problematic alcohol use, as well as depression and quality of life. Method: Participants with problematic alcohol use who, after an initial evaluation consisting of five face-to-face sessions with a licensed psychologist where alcohol and collateral problems are extensively assessed, are recommended treatment for problematic alcohol use. Consenting participants will be randomized into one of two groups: 1. Internet delivered relapse prevention with therapist support or 2. Face-to-face therapy. Outcomes on alcohol use, depression and quality of life as well as information on user satisfaction will be gathered post treatment. Follow up will be at 3, 6 and 12 months after completion. Our hypothesis is that the internet-based program with therapist support and the face-to-face therapy will be equally effective in reducing alcohol use (non-inferiority).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 18, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

2.2 years

First QC Date

December 12, 2013

Last Update Submit

March 14, 2016

Conditions

Alcohol AbuseAlcohol Addiction

Keywords

Randomized Controlled TrialAlcoholInternetInternet based therapyCognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

  • Alcohol Use Identification Test (AUDIT)

    Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)

    Post, 3, 6 and 12 months

Secondary Outcomes (3)

  • Time Line Follow Back (TLFB)

    Post, 3, 6 and 12 months

  • Montgomery Asberg Depression Rating Scale - Self report (MADRS-S)

    Post, 3, 6 and 12 months

  • World Health Quality of Life Scale (WHOQOL-BREF)

    Post, 3, 6 and 12 months

Other Outcomes (2)

  • Drug Use Identification Test (DUDIT)

    Post, 3, 6 and 12 months

  • Biological tests for alcohol markers

    Post

Study Arms (2)

eChange web-based relapse prevention

EXPERIMENTAL

A relapse intervention program consisting of 14 modules. Patients will have access to therapist support through an internal secure messaging system.

Behavioral: eChange

Face-to-face therapy

ACTIVE COMPARATOR

Face-to-face psychotherapy, consisting of 20 sessions. The content will be vary for different therapists, but all have an evidence-based approach to therapy

Behavioral: Face-to-face therapy

Interventions

eChangeBEHAVIORAL

A web-based relapse intervention program consisting of 14 modules. The patient will have access to therapist support through a secure messaging system

eChange web-based relapse prevention
Face-to-face therapyBEHAVIORAL

Face-to-face psychotherapy, consisting of 20 sessions. The content will be different for different therapists, but all have an evidence based approach to therapy

Face-to-face therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Problematic alcohol use and having been recommended psychotherapy by the assessing psychologist.

You may not qualify if:

  • Inadequate Swedish language skills No Internet access Reading and/or writing difficulties Major depression Current suicidal thoughts and/or plans Primary problematic drug use PTSD-related problems Psychosis Cognitive disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska institutet, Department of Clinical Neuroscience

Stockholm, 171 76, Sweden

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Anne H Berman, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 12, 2013

First Posted

December 18, 2013

Study Start

January 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 15, 2016

Record last verified: 2016-03

Locations

SE(1)