NCT02671019

Brief Summary

The purpose of this trial is to compare the effectiveness and costs of a five-module Internet-based treatment program (including therapist support) for harmful alcohol use with the effectiveness and cost of the same treatment content delivered face-to-face in specialized addiction treatment. The hypotheses to be tested through this trial are that:

  1. 1.The Internet-based treatment program (including therapist support) is as effective (reducing alcohol consumption) as the same treatment content delivered face-to-face in specialized addiction treatment.
  2. 2.The Internet-based treatment program (including therapist support) is associated with lower cost per treated individual in relation to the achieved effects (in terms of reduced alcohol consumption) compared with the same treatment content delivered face-to-face in specialized addiction treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
303

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

4.1 years

First QC Date

January 11, 2016

Last Update Submit

May 29, 2019

Conditions

Alcohol Use Disorders

Outcome Measures

Primary Outcomes (1)

  • Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method

    3 months post-randomization

Secondary Outcomes (35)

  • Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method

    6 months post-randomization

  • Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method

    12 months post-randomization

  • Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method

    24 months post-randomization

  • Alcohol Use Disorders Identification Test score

    3 months post-randomization

  • Alcohol Use Disorders Identification Test score

    6 months post-randomization

  • +30 more secondary outcomes

Study Arms (2)

Internet-based treatment

EXPERIMENTAL

A five-module Internet-based treatment program for harmful alcohol use (including therapist support) based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.

Behavioral: Guide to better alcohol habits

Face-to-face treatment

ACTIVE COMPARATOR

Same treatment content as in the Internet-based treatment delivered via face-to-face treatment sessions in specialized addiction treatment.

Behavioral: Guide to better alcohol habits

Interventions

Guide to better alcohol habitsBEHAVIORAL

A treatment for harmful alcohol use based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.

Face-to-face treatmentInternet-based treatment

Eligibility Criteria

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

You may qualify if:

  • years or older
  • points on Alcohol Use Disorders Identification Test or at least 3 criteria on the International Classification of Diseases (ICD-10) for Alcohol Dependence
  • Resident in Stockholm County

You may not qualify if:

  • Lack of understanding of the Swedish language.
  • Doctor's assessment that there is a risk for severe withdrawal symptoms, risk for suicide or mental illness requiring separate care.
  • Doctor's assessment that there is a need for medication for alcohol dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 171 77, Sweden

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

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
PhD

Study Record Dates

First Submitted

January 11, 2016

First Posted

February 2, 2016

Study Start

November 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

May 30, 2019

Record last verified: 2019-05

Locations

SE(1)