A Smartphone Based Intervention for the Prevention of Relapse in Alcohol Dependence

NCT03952429 | Completed

• 1 other identifier: SPIRA
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The rate of relapse following an inpatient alcohol rehabilitation program has been around 50% for a number of years. Offered treatments mainly focus on conscious and controllable aspects of behaviour, but research has found that much of the craving in addiction is guided by automatic processes, which are for a large part unconscious and poorly controlled by the individual. One way to influence these automatic processes is by applying cognitive bias modification, a cognitive-behavioural intervention that can be applied by a computer application. In alcohol addition, a common cognitive bias is the Alcohol-Approach bias. The Anti-Alcohol Training is a form of cognitive bias modification that was developed to reduce this approach bias and it has been shown to reduce the rates of relapse by 4-8%. A drawback of the training is that patients do not continue this at home after discharge. One way to increase accessibility is to offer the training in an app-game form. In this study the investigators have developed a smartphone based training app that allows patients to more easily use the Anti-Alcohol training at home after discharge. The study aims to assess whether use of the app further reduces the alcohol bias and whether it can reduce yearly relapse rates.

Conditions

Alcohol Dependence; Alcohol Abuse; Alcohol Use Disorder

Keywords

alcohol dependence; alcohol abuse; withdrawal

Outcome Measures

Primary Outcomes (3)

• Relapse Rates

  Relapse rates after leaving inpatient care, assessed through standard clinic follow-ups

  3 months after care, 1 year after care

• App Usage

  Number of times App training has been completed

  within 3 months after leaving care

• Craving

  Craving for alcohol assessed in app, 5 point likert scale with alcohol images, OCDS

  after 5 training sessions of the app

Study Arms (2)

Active Cognitive Bias App

ACTIVE COMPARATOR

Participants will receive the Anti-Alcohol App with the Active Cognitive Bias modification, as well as participant diaries assessing alcohol consumption and several questionnaires.

Behavioral: Anti Alcohol App with Active Cognitive Bias

Inactive Cognitive Bias Modification

PLACEBO COMPARATOR

Participants will receive the Anti-Alcohol App with the Inactive Cognitive Bias Modification, as well as participant diaries assessing alcohol consumption and several questionnaires.

Behavioral: Inactive Cognitive Bias Modification

Interventions

Anti Alcohol App with Active Cognitive Bias BEHAVIORAL

The active version includes an active form of cognitive bias modification, i.e. the user has to avoid alcohol stimuli 90% of the time, while they approach soft drinks 90% of the time.

Active Cognitive Bias App

Inactive Cognitive Bias Modification BEHAVIORAL

The control version includes an placebo form of cognitive bias modification, i.e. the users avoid and approach alcohol and softdrink stimuli for an equal number of trials.

Inactive Cognitive Bias Modification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of Alcohol dependence / Alcohol Use disorder
• Taking part in alcohol rehabilitation program in Salus Clinic Lindow or being part of a self-help group

You may not qualify if:

• Visual or motor impairments that would affect the use of smartphones

Sponsors & Collaborators

• Salus Klinik Lindow: lead
• University of Cambridge: collaborator

Study Sites (1)

Salus Klinik Lindow

Lindow, Brandenburg, Germany

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol; Amyloid

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Prof Johannes Lindemeyer

  Medizinische Hochschule Brandenburg Theodor Fontane

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be notified there are 2 versions of the app and they will randomly be assigned to one of the 2 conditions, but will not know which one. Therapists giving the users input on how to use the app do not know in which condition the patient is either. Outcome (relapse rates) are assessed by interns and admin staff of the clinic who are independent from the study. The study investigators do not know the patients and only receive anonymized data on group and outcome variables.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This is a parallel study, participants will be randomised into 2 groups: one will be given the App with cognitive bias modification, whilst the other one will receive the app without the modification

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 16, 2019
• Study Start: May 23, 2019
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

DE (1)