A Smartphone Based Intervention for the Prevention of Relapse in Alcohol Dependence (SPIRA)
Primary Purpose
Alcohol Dependence, Alcohol Abuse, Alcohol Use Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Anti Alcohol App with Active Cognitive Bias
Inactive Cognitive Bias Modification
Sponsored by
About this trial
This is an interventional supportive care trial for Alcohol Dependence focused on measuring alcohol dependence, alcohol abuse, withdrawal
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
Sites / Locations
- Salus Klinik LindowRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active Cognitive Bias App
Inactive Cognitive Bias Modification
Arm Description
Participants will receive the Anti-Alcohol App with the Active Cognitive Bias modification, as well as participant diaries assessing alcohol consumption and several questionnaires.
Participants will receive the Anti-Alcohol App with the Inactive Cognitive Bias Modification, as well as participant diaries assessing alcohol consumption and several questionnaires.
Outcomes
Primary Outcome Measures
Relapse Rates
Relapse rates after leaving inpatient care, assessed through standard clinic follow-ups
App Usage
Number of times App training has been completed
Craving
Craving for alcohol assessed in app, 5 point likert scale with alcohol images, OCDS
Secondary Outcome Measures
Full Information
NCT ID
NCT03952429
First Posted
May 10, 2019
Last Updated
December 25, 2021
Sponsor
Salus Klinik Lindow
Collaborators
University of Cambridge
1. Study Identification
Unique Protocol Identification Number
NCT03952429
Brief Title
A Smartphone Based Intervention for the Prevention of Relapse in Alcohol Dependence
Acronym
SPIRA
Official Title
SPIRA: Development of a Smartphone Based Intervention for the Prevention of Relapse in Alcohol Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Salus Klinik Lindow
Collaborators
University of Cambridge
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Alcohol Abuse, Alcohol Use Disorder
Keywords
alcohol dependence, alcohol abuse, withdrawal
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Cognitive Bias App
Arm Type
Active Comparator
Arm Description
Participants will receive the Anti-Alcohol App with the Active Cognitive Bias modification, as well as participant diaries assessing alcohol consumption and several questionnaires.
Arm Title
Inactive Cognitive Bias Modification
Arm Type
Placebo Comparator
Arm Description
Participants will receive the Anti-Alcohol App with the Inactive Cognitive Bias Modification, as well as participant diaries assessing alcohol consumption and several questionnaires.
Intervention Type
Behavioral
Intervention Name(s)
Anti Alcohol App with Active Cognitive Bias
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Inactive Cognitive Bias Modification
Intervention Description
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 Outcome Measure Information:
Title
Relapse Rates
Description
Relapse rates after leaving inpatient care, assessed through standard clinic follow-ups
Time Frame
3 months after care
Title
App Usage
Description
Number of times App training has been completed
Time Frame
within 3 months after leaving care
Title
Craving
Description
Craving for alcohol assessed in app, 5 point likert scale with alcohol images, OCDS
Time Frame
after 5 training sessions of the app
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prof Johannes Lindenmeyer
Phone
49 3391 39-14210
Email
mail@salus-lindow.de
First Name & Middle Initial & Last Name or Official Title & Degree
Nele Peerenboom
Phone
49 3391 39-14210
Email
nap42@cam.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof Johannes Lindemeyer
Organizational Affiliation
Medizinische Hochschule Brandenburg Theodor Fontane
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salus Klinik Lindow
City
Lindow
State/Province
Brandenburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Schöneck
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymised participant data will be shared with the collaborators at Cambridge University
Learn more about this trial
A Smartphone Based Intervention for the Prevention of Relapse in Alcohol Dependence
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