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: Recruiting
• Conditions: Alcohol Dependence; Alcohol Use Disorder; Alcohol Abuse
• Intervention / Treatment: Behavioral: Anti Alcohol App with Active Cognitive Bias; Behavioral: Inactive Cognitive Bias Modification

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: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prof Johannes Lindenmeyer; Phone Number: 49 3391 39-14210; Email: mail@salus-lindow.de
• Study Contact Backup: Name: Nele Peerenboom; Phone Number: 49 3391 39-14210; Email: nap42@cam.ac.uk

Study Locations

• Germany
  • Brandenburg
    • Lindow, Brandenburg, Germany
      • Recruiting
      • Salus Klinik Lindow
      • Contact: Robert Schöneck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse Rates	Relapse rates after leaving inpatient care, assessed through standard clinic follow-ups	3 months after care
App Usage	Number of times App training has been completed	within 3 months after leaving care
Craving	Craving for alcohol assessed in app, 5 point likert scale with alcohol images, OCDS	after 5 training sessions of the app

Collaborators and Investigators

• Sponsor: Salus Klinik Lindow
• Collaborators: University of Cambridge
• Investigators: Principal Investigator: Prof Johannes Lindemeyer, Medizinische Hochschule Brandenburg Theodor Fontane

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2019
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 25, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: alcohol dependence; withdrawal; alcohol abuse
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: SPIRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Anonymised participant data will be shared with the collaborators at Cambridge University
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No