NCT02377726

Brief Summary

Internet based self help program with or without support of a counselor is tested among anonymous Internet help seekers at an open access website.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 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

First Submitted

Initial submission to the registry

February 26, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
28 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

4.7 years

First QC Date

February 26, 2015

Last Update Submit

November 9, 2023

Conditions

Keywords

Randomized Controlled TrialAlcoholInternetInternet based therapyCognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

  • Time Line Follow Back (TLFB) (Change in total in consumption of alcohol last 7 days)

    Change in total in consumption of alcohol last 7 days

    3, 6, 12 and 24 months

Secondary Outcomes (11)

  • Time Line Follow Back (TLFB) (Change in number of standard drinks per day during last 7 days)

    3, 6, 12 and 24 months

  • Time Line Follow Back (TLFB) (Change in number of consumption days during last 7 days)

    3, 6, 12 and 24 months

  • Time Line Follow Back (TLFB) (Change in number of days binge-drinking days during last 7 days)

    3, 6, 12 and 24 months

  • Alcohol dependence (ICD-10) (Change in number of criteria for alcohol dependence met)

    3, 6, 12 and 24 months

  • Alcohol Use Disorder (DSM-5) (Change in number of criteria for alcohol use disorder met)

    3, 6, 12 and 24 months

  • +6 more secondary outcomes

Other Outcomes (3)

  • The Readiness Ruler (Scores between 0 and 100)

    3, 6, 12 and 24 months

  • Use of Internet based program and website (Number of visits and number of completed exercises in the Internet based program and website)

    From baseline to 3 months

  • Working alliance with internet based intervention (eSRS) (4 scale questions on the users alliance with the internet based intervention )

    2 and 5 weeks

Study Arms (3)

Internet self-help with support

EXPERIMENTAL

eChange Alkoholhjälpen is an internet based self help program consisting of 5 modules. Patients will have access to Alkoholhjälpen counselor support through secure comments at every module they complete.

Behavioral: Alkoholhjälpen counselor supportBehavioral: eChange Alkoholhjälpen

Internet self-help

EXPERIMENTAL

eChange Alkoholhjälpen is an internet based self help program consisting of 5 modules.

Behavioral: eChange Alkoholhjälpen

Information

ACTIVE COMPARATOR

Brief information on resources that can be accessed through the open access website Alkoholhjälpen: Information on alcohol and health, where and how to find treatment and an internet discussion forum.

Behavioral: Alkoholhjälpen

Interventions

Users will have access to counselor support through secure comments at the end of every module they complete in the self help program.

Internet self-help with support

An internet based intervention program (iCBT) consisting of 5 modules. Fully automated self-help

Internet self-helpInternet self-help with support
AlkoholhjälpenBEHAVIORAL

A swedish, open access website that includes information on alcohol, on how to find treatment and an internet discussion forum

Also known as: alcoholhjalpen.se, alcohol-help-site
Information

Eligibility Criteria

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

You may qualify if:

  • AUDIT-score \>16 points and/or at least 3 criteria of alcohol dependence (ICD-10)

You may not qualify if:

  • Inadequate Swedish language skills No Internet access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet, Department of Public Health Sciences

Stockholm, 17176, Sweden

Location

Related Publications (2)

  • Sinadinovic K, Wennberg P, Johansson M, Berman AH. Targeting individuals with problematic alcohol use via Web-based cognitive-behavioral self-help modules, personalized screening feedback or assessment only: a randomized controlled trial. Eur Addict Res. 2014;20(6):305-18. doi: 10.1159/000362406. Epub 2014 Oct 4.

    PMID: 25300885BACKGROUND
  • Johansson M, Berman AH, Sinadinovic K, Lindner P, Hermansson U, Andreasson S. Effects of Internet-Based Cognitive Behavioral Therapy for Harmful Alcohol Use and Alcohol Dependence as Self-help or With Therapist Guidance: Three-Armed Randomized Trial. J Med Internet Res. 2021 Nov 24;23(11):e29666. doi: 10.2196/29666.

Related Links

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Sven Andreasson, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
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 4, 2015

Study Start

April 1, 2015

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations