Internet-Based Relapse Prevention vs Face to Face Therapy at an Employee Assistance Program

NCT ID: NCT02014779

Last Updated: 2016-03-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-03-31

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).

Conditions

Alcohol Abuse; Alcohol Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

eChange web-based relapse prevention

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

Group Type: EXPERIMENTAL

eChange

Intervention Type: BEHAVIORAL

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

Face-to-face therapy

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

Group Type: ACTIVE_COMPARATOR

Face-to-face therapy

Intervention Type: BEHAVIORAL

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

Interventions

eChange

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

Intervention Type: BEHAVIORAL

Face-to-face therapy

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

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

Sponsors

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, Department of Clinical Neuroscience

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

2013/1391-31/5

Identifier Type: -

Identifier Source: org_study_id