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Completed

NCT Number: NCT03952429

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

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.

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Key information

Conditions

Alcohol Dependence Alcohol Abuse Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salus Klinik Lindow

Lindow, Brandenburg, Germany

About this study

The rate of relapse following an inpatient alcohol rehabilitation program has been around 50% for a number of years, in spite of many initiatives to try and reduce relapse. One of the reasons could be that the offered treatments mainly focus on conscious and controllable aspects of behaviour. Recent research has however 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. Unsurprisingly, many attempts have therefore been made in addition research to reduce these automatic impulsive behaviour and improve the control processes.

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 tendency to automatically approach alcohol. The Anti-Alcohol Training is a form of cognitive bias modification that was developed to reduce this approach bias. Studies have shows that this training can reduce the rates of relapse by 4-8%.

A drawback of the training is that patients often do not continue this at home after discharge, probably due to low motivation. One way to resolve this issue could be to offer the training in an App-game form, which would make it more accessible and inviting to continue using it after return home.

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 alcohol dependent patients continue to use this app at home, whether the use of the app further reduces the alcohol bias, and finally whether it can reduce yearly relapse rates.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Relapse Rates

    Time frame: 3 months after care, 1 year after care

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

  2. App Usage

    Time frame: within 3 months after leaving care

    Number of times App training has been completed

  3. Craving

    Time frame: after 5 training sessions of the app

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

Sponsors and collaborators

Lead sponsor

Salus Klinik Lindow

Network

Collaborators

  • University of Cambridge

Registry information

Official study title

SPIRA: Development of a Smartphone Based Intervention for the Prevention of Relapse in Alcohol Dependence

Acronym: SPIRA

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 16, 2019
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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