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

• ClinicalTrials.gov Identifier: NCT03952429
• Recruitment Status: Recruiting
• First Posted: May 16, 2019
• Last Update Posted: January 11, 2022
• Sponsor: Salus Klinik Lindow
• Collaborator: University of Cambridge
• Information provided by (Responsible Party): Salus Klinik Lindow

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.

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.

Study Design

• 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
• Actual Study Start Date: May 23, 2019
• Estimated Primary Completion Date: July 31, 2022
• Estimated Study Completion Date: July 31, 2022

Arms and Interventions

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.

Outcome Measures

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, OCDS

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Prof Johannes Lindenmeyer; 49 3391 39-14210; mail@salus-lindow.de

Contact: Nele Peerenboom; 49 3391 39-14210; nap42@cam.ac.uk

Locations

Germany

Salus Klinik Lindow; Recruiting

Lindow, Brandenburg, Germany

Contact: Robert Schöneck

Sponsors and Collaborators

Salus Klinik Lindow

University of Cambridge

Investigators

• Principal Investigator: Prof Johannes Lindemeyer; Medizinische Hochschule Brandenburg Theodor Fontane

More Information

• Responsible Party: Salus Klinik Lindow
• ClinicalTrials.gov Identifier: NCT03952429
• Other Study ID Numbers: SPIRA
• First Posted: May 16, 2019
• Last Update Posted: January 11, 2022
• Last Verified: December 2021

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

• 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:

Alcoholism; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders