A Smartphone Based Intervention for the Prevention of Relapse in Alcohol Dependence (SPIRA)
SPIRA: Development of 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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Brandenburg
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Lindow, Brandenburg, Germany
- Salus Klinik Lindow
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Active Cognitive Bias App
Participants will receive the Anti-Alcohol App with the Active Cognitive Bias modification, as well as participant diaries assessing alcohol consumption and several questionnaires.
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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.
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Placebo Comparator: Inactive Cognitive Bias Modification
Participants will receive the Anti-Alcohol App with the Inactive Cognitive Bias Modification, as well as participant diaries assessing alcohol consumption and several questionnaires.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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App Usage
Time Frame: within 3 months after leaving care
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Number of times App training has been completed
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within 3 months after leaving care
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Craving
Time Frame: after 5 training sessions of the app
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Craving for alcohol assessed in app, 5 point likert scale with alcohol images, OCDS
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after 5 training sessions of the app
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Relapse Rates
Time Frame: 3 months after care, 1 year after care
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Relapse rates after leaving inpatient care, assessed through standard clinic follow-ups
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3 months after care, 1 year after care
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Prof Johannes Lindemeyer, Medizinische Hochschule Brandenburg Theodor Fontane
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPIRA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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