NCT02384304

Brief Summary

The purpose of this study was to determine whether a 10-week internet-based program based on cognitive behavioral therapy (CBT) is effective in the treatment of alcohol problems, and if having therapist guidance leads to greater effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
Last Updated

September 2, 2015

Status Verified

August 1, 2015

Enrollment Period

3 months

First QC Date

February 26, 2015

Last Update Submit

August 31, 2015

Conditions

Keywords

randomized controlled trialalcoholinternetinternet based therapycognitive behavior therapy

Outcome Measures

Primary Outcomes (1)

  • Time Line Follow Back (TLFB)

    Change in total TLFB score (consumption during preceding week), as a summarized measure of alcohol consumption

    Baseline and 10 weeks

Secondary Outcomes (4)

  • Alcohol Use Disorders Identification Test (AUDIT)

    Baseline and 10 weeks

  • Hamilton Anxiety and Depression Scale (HADS)

    Baseline and 10 weeks

  • EQ5

    Baseline and 10 weeks

  • WHOQOL-BREF

    Baseline and 10 weeks

Study Arms (3)

Choice

EXPERIMENTAL

A self help program consisting of 8 modules. Patients will have access to therapist support through either messages or chat sessions

Behavioral: Choice

Messages

EXPERIMENTAL

A self help program consisting of 8 modules. Patients will have access to therapist support through messages

Behavioral: Messages

Self help

ACTIVE COMPARATOR

A relapse intervention program consisting of 8 modules. Patients will have no access to therapist support

Behavioral: Self help

Interventions

ChoiceBEHAVIORAL

A self help program consisting of 8 modules and access to therapist guidance either through messages or through chat sessions

Choice
MessagesBEHAVIORAL

A self help program consisting of 8 modules and access to therapist guidance through messages

Messages
Self helpBEHAVIORAL

A self help program consisting of 8 modules

Self help

Eligibility Criteria

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

You may qualify if:

  • ≥ 18 years
  • access to the Internet
  • problematic alcohol use defined as ≥ 8 p or more for men and ≥ 6 p or more for women in the Alcohol Use Identification Scale

You may not qualify if:

  • not adequately fluent in Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research

Stockholm, Stockholm County, 11364, Sweden

Location

Related Publications (2)

  • Sundström, C., Berman, A. H., Sinadinovic, K., & Johansson, M. (2013). Internet-based relapse prevention with therapist support for help-seeking problematic alcohol users: a randomized pilot study. Addiction science & clinical practice, 8(1), 1-1.

    BACKGROUND
  • Sundstrom C, Gajecki M, Johansson M, Blankers M, Sinadinovic K, Stenlund-Gens E, Berman AH. Guided and Unguided Internet-Based Treatment for Problematic Alcohol Use - A Randomized Controlled Pilot Trial. PLoS One. 2016 Jul 6;11(7):e0157817. doi: 10.1371/journal.pone.0157817. eCollection 2016.

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
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 26, 2015

First Posted

March 10, 2015

Study Start

December 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 2, 2015

Record last verified: 2015-08

Locations