Clinical trial NCT03952429: A Smartphone Based Intervention for the Prevention of Relapse in Alcohol Dependence
Official title: SPIRA: Development of a Smartphone Based Intervention for the Prevention of Relapse in Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Dependence
Alcohol Abuse
Alcohol Use Disorder
Keywords: alcohol dependence
alcohol abuse
withdrawal
Lead sponsor: Salus Klinik Lindow
Sponsor class: NETWORK
Collaborators: name: University of Cambridge
First posted: 2019-05-16
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Relapse Rates
timeFrame: 3 months after care
measure: App Usage
timeFrame: within 3 months after leaving care
measure: Craving
timeFrame: after 5 training sessions of the app
Secondary outcomes:
Other outcomes:
Locations:
city: Lindow
country: Germany
facility: Salus Klinik Lindow
state: Brandenburg
Study officials:
affiliation: Medizinische Hochschule Brandenburg Theodor Fontane
name: Prof Johannes Lindemeyer
role: PRINCIPAL_INVESTIGATOR
References: