NCT05037630

Brief Summary

The purpose of the study is to evaluate the feasibility of a new monitored self-guided digital intervention based on an alcohol diary and techniques from cognitive behavioral therapy and relapse prevention. The participants will be adults with problematic alcohol use. An uncontrolled trial will explore participant's usability and treatment credibility ratings, behavioural engagement and preliminary effects on alcohol use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

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

First Submitted

Initial submission to the registry

August 27, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

September 27, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

August 27, 2021

Last Update Submit

May 20, 2022

Conditions

Alcohol Consumption

Outcome Measures

Primary Outcomes (2)

  • Standardized drinks per week (based on Time Line Follow Back)

    Changes in standardized drinks per week (using Time Line Follow Back)

    3 months after intervention

  • Heavy drinking days (based on Time Line Follow Back)

    Changes in number of heavy drinking days (defined as ≥ 5 (men) or ≥ 4 (women) standardized drinks on a single day, using the Time Line Follow Back)

    3 months after intervention

Secondary Outcomes (16)

  • Standardized drinks per week (based on Time Line Follow Back)

    Immediately after the intervention

  • Heavy drinking days (based on Time Line Follow Back)

    Immediately after the intervention

  • Diagnostic criteria Alcohol Use Disorder

    3 months after intervention

  • Diagnostic criteria Alcohol Use Disorder

    Immediately after the intervention

  • System Usability Scale

    Immediately after the intervention

  • +11 more secondary outcomes

Other Outcomes (2)

  • Behavioral engagement

    Immediately after the intervention

  • Telephone interview on perceptions of intervention

    Immediately after the intervention

Study Arms (1)

Self-guided Digital Tool for Problematic Alcohol Use

EXPERIMENTAL

Self-guided Digital Tool for Problematic Alcohol Use during 8 weeks with clinical telephone interviews pre ant post intervention.

Behavioral: Self-guided Digital Tool for Problematic Alcohol Use

Interventions

Self-guided Digital Tool for Problematic Alcohol UseBEHAVIORAL

See arm/group-description

Also known as: ALVA
Self-guided Digital Tool for Problematic Alcohol Use

Eligibility Criteria

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

You may qualify if:

  • ≥ 18 years of age
  • Access to internet
  • ≥8 points for men and ≥6 points for women on Alcohol Use Disorders Identification Test (AUDIT)

You may not qualify if:

  • Insufficient knowledge of the Swedish language
  • Difficulties reading or writing related to a digital intervention.
  • Other ongoing psychological treatment with a content similar to that in the current study (problematic alcohol use).
  • High suicide risk based on telephone assessment.
  • Other urgent need for more intensive psychiatric care, or addiction care services, based on telephone assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centrum för Psykiatriforskning

Stockholm, Sweden

Location

Related Publications (1)

  • Kraepelien M, Sundstrom C, Johansson M, Ivanova E. Digital psychological self-care for problematic alcohol use: feasibility of a new clinical concept. BJPsych Open. 2023 May 24;9(3):e91. doi: 10.1192/bjo.2023.73.

    PMID: 37222099DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Licensed clinical psychologist, Principal investigator, PhD

Study Record Dates

First Submitted

August 27, 2021

First Posted

September 8, 2021

Study Start

September 27, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

May 23, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)