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

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ClinicalTrials.gov Identifier: NCT03952429
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 20, 2019
Sponsor:
Collaborator:
University of Cambridge
Information provided by (Responsible Party):
Salus Klinik Lindow

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.


Condition or disease Intervention/treatment Phase
Alcohol Dependence Alcohol Abuse Alcohol Use Disorder Behavioral: Anti Alcohol App with Active Cognitive Bias Behavioral: Inactive Cognitive Bias Modification Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Supportive Care
Official Title: SPIRA: Development of a Smartphone Based Intervention for the Prevention of Relapse in Alcohol Dependence
Estimated Study Start Date : May 16, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
Behavioral: 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.




Primary Outcome Measures :
  1. Relapse Rates [ Time Frame: 3 months 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

  4. Alcohol Units consumed [ Time Frame: after 5 training sessions of the app ]
    average number of alcohol units consumed, assessed through self-report

  5. Time to Relapse [ Time Frame: within 3 months after care, assessed through questions on the app ]
    Time to first relapse after leaving inpatient care



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952429


Contacts
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Contact: Prof Johannes Lindenmeyer 49 3391 39-14210 mail@salus-lindow.de
Contact: Nele Peerenboom 49 3391 39-14210 nap42@cam.ac.uk

Sponsors and Collaborators
Salus Klinik Lindow
University of Cambridge
Investigators
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Principal Investigator: Prof Johannes Lindemeyer Medizinische Hochschule Brandenburg Theodor Fontane

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Responsible Party: Salus Klinik Lindow
ClinicalTrials.gov Identifier: NCT03952429     History of Changes
Other Study ID Numbers: SPIRA
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised participant data will be shared with the collaborators at Cambridge University
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Salus Klinik Lindow:
alcohol dependence
alcohol abuse
withdrawal

Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs