NCT02645721

Brief Summary

The purpose of this study is to determine whether extensive internet based cognitive behavior treatment program with guidance is a more effective method to treat individuals with alcohol use disorders than a briefer cognitive behavior treatment program without guidance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

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

January 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

June 25, 2020

Status Verified

June 1, 2020

Enrollment Period

3.4 years

First QC Date

January 2, 2016

Last Update Submit

June 23, 2020

Conditions

Alcohol Use Disorders

Outcome Measures

Primary Outcomes (2)

  • Time Line Follow Back

    Number of standard drinks during preceding week (using the Time Line Follow Back)

    Screening; Changes before treatment, Post-treatment (12 weeks); and changes after 3-, 12-, and 24-months post-treatment

  • Time Line Follow Back

    Days of heavy drinking during preceding week (using the Time Line Follow Back)

    Screening; Changes before treatment, Post-treatment (12 weeks); and changes after 3-, 12-, and 24-months post-treatment

Secondary Outcomes (13)

  • Alcohol Use Disorders Identification Test

    Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment

  • Alcohol Abstinence Self Efficacy Scale

    Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment

  • Penn Alcohol Craving Scale

    Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment

  • Montgomery Asberg Depression Rating Scale

    Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment

  • Euro-QOL 5 D

    Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment

  • +8 more secondary outcomes

Study Arms (3)

Extended self-help program with guidance

EXPERIMENTAL

The program is a comprehensive CBT program lasting 12 weeks, with as many modules. The modules are quite extensive. A guide with basic education in psychotherapy assists and counsels participants online.

Behavioral: Extended self-help program with guidance

Briefer Self-help program, no guidance

ACTIVE COMPARATOR

This self-help program also lasts 12 weeks but contains only 9 modules; a pause occurs during the final weeks of the program for self-testing of acquired skills. The modules are quite brief. Participants receive no guidance.

Behavioral: Briefer Self-help program, no guidance

WL: Extended self-help program, choice of guidance intensity

OTHER

Participants will be put on a waiting list. After 12 weeks on the waiting list, participants will receive access the the extended self-help program used in the experimental arm. However, participants will be offered a choice between three guidance options of varying intensity: proactive guidance, reactive guidance (only at participant request) or no guidance.

Behavioral: WL: Extended self-help program, choice of guidance intensity

Interventions

Extended self-help program with guidanceBEHAVIORAL

See arm description for Experimental

Also known as: ePlus with guidance
Extended self-help program with guidance
Briefer Self-help program, no guidanceBEHAVIORAL

See arm description for Active Comparator

Also known as: eChange
Briefer Self-help program, no guidance
WL: Extended self-help program, choice of guidance intensityBEHAVIORAL

See arm description for Waiting list.

Also known as: ePlus with choice of guidance intensity
WL: Extended self-help program, choice of guidance intensity

Eligibility Criteria

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

You may qualify if:

  • ≥ 18 years
  • access to the internet
  • consumption of at least 9 (females)/14 (males) glasses of alcohol during the preceding week
  • AUDIT ≥ 14 for females, ≥ 16 for men
  • have an Alcohol Use Disorder according to the DSM-5 (i.e., at least 2 out of 11 criteria)

You may not qualify if:

  • insufficient Swedish skills
  • reading or writing difficulties, if it is to a degree that it will hamper the treatment
  • concurrent other psychological treatment with a content resembling treatments in this study
  • severe depression defined as a score of more than 30 on the MADRS-S
  • suicide-risk defined as more than 4 points on the MADRS-S question 9, or based on the structured interview
  • Drug use problems defined as ≥ 8 p on the DUDIT
  • somatic or psychiatric disorders that are contraindicated for the treatment or impairs the ability to receive it (for example schizophrenia, bipolar disease, PTSD)
  • has during the last 3 weeks begun medication for alcohol problems or other psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 11364, Sweden

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Counseling

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

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

January 2, 2016

First Posted

January 5, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

June 25, 2020

Record last verified: 2020-06

Locations

SE(1)