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

Alcohol Use Disorder Clinical Trial

— SPIRA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03952429
• Other study ID #: SPIRA
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: December 2021
• Source: Salus Klinik Lindow
• Contact: Prof Johannes Lindenmeyer
• Phone: 49 3391 39-14210
• Email: mail[@]salus-lindow.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Dependence
• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• Anti Alcohol App with Active Cognitive Bias
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
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.

Locations

Country	Name	City	State
Germany	Salus Klinik Lindow	Lindow	Brandenburg

Sponsors (2)

Lead Sponsor	Collaborator
Salus Klinik Lindow	University of Cambridge

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse Rates	Relapse rates after leaving inpatient care, assessed through standard clinic follow-ups	3 months after care
Primary	App Usage	Number of times App training has been completed	within 3 months after leaving care
Primary	Craving	Craving for alcohol assessed in app, 5 point likert scale with alcohol images, OCDS	after 5 training sessions of the app