NCT02888002

Brief Summary

A brief treatment program (MI/CBT) via face-to-face or via internet is tested in association with an outpatient addictions clinic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 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

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2016

Completed
8 months until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

September 2, 2020

Status Verified

September 1, 2020

Enrollment Period

4.3 years

First QC Date

January 17, 2016

Last Update Submit

September 1, 2020

Conditions

Alcohol AbuseAlcohol DependenceHarmful Alcohol UseAlcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Time Line Follow Back (TLFB)

    Change in number of standard drinks per day during last 7 days

    3, 6, 12 and 24 months

Secondary Outcomes (8)

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

    3, 6, 12 and 24 months

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

    3, 6, 12 and 24 months

  • Alcohol Use Disorders Identification Test Consumption (AUDIT-C)

    3, 6, 12 and 24 months

  • Alcohol Use Disorders Identification Test (AUDIT)

    3, 6, 12 and 24 months

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

    3, 6, 12 and 24 months

  • +3 more secondary outcomes

Other Outcomes (4)

  • The Readiness Ruler

    3, 6, 12 and 24 month

  • Use of Internet-based program and website

    From baseline to 3 months

  • Session rating scale (SRS)

    2 and 5 weeks in to treatment

  • +1 more other outcomes

Study Arms (2)

Internet-based treatment

EXPERIMENTAL

"Guide to better alcohol habits online". An Internet-based treatment program with online counselor support.

Behavioral: Guide to better alcohol habits

Face-to-face treatment

EXPERIMENTAL

"Guide to better alcohol habits F2F": Face-to-face treatment with 5 individual counselor sessions at the clinic.

Behavioral: Guide to better alcohol habits

Interventions

Guide to better alcohol habitsBEHAVIORAL

A 5-module therapeutic program wich includes self-help material in printed or web-based form with interactive exercises. The program includes instructions for the therapist.

Also known as: Motivational Interviewing (MI), Cognitive Behavioral Therapy (CBT), Behavioral Self-Control Training, eChange
Face-to-face treatmentInternet-based treatment

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Risk of severe withdrawal symptoms.
  • Risk of suicide.
  • Other psychiatric diagnosis that requires current treatment.
  • Need for medication for alcohol dependence.
  • 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 (1)

  • 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

Related Links

MeSH Terms

Conditions

Alcoholism

Interventions

EthanolMotivational InterviewingCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsDirective CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesBehavior TherapyPsychotherapy

Study Officials

  • Sven Andreasson, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 17, 2016

First Posted

September 2, 2016

Study Start

December 1, 2015

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

September 2, 2020

Record last verified: 2020-09

Locations

SE(1)