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

SPIRA: Development of a Smartphone Based Intervention for the Prevention of Relapse in Alcohol Dependence

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03952429
Acronym
SPIRA
Enrollment
600
Registered
2019-05-16
Start date
2019-05-23
Completion date
2023-10-27
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Abuse, Alcohol Dependence, Alcohol Use Disorder

Keywords

alcohol dependence, alcohol abuse, withdrawal

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.

Interventions

BEHAVIORALAnti 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.

BEHAVIORALInactive 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.

Sponsors

Salus Klinik Lindow
Lead SponsorNETWORK
University of Cambridge
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, 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.

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Relapse Rates3 months after care, 1 year after careRelapse rates after leaving inpatient care, assessed through standard clinic follow-ups
App Usagewithin 3 months after leaving careNumber of times App training has been completed
Cravingafter 5 training sessions of the appCraving for alcohol assessed in app, 5 point likert scale with alcohol images, OCDS

Countries

Germany

Contacts

PRINCIPAL_INVESTIGATORProf Johannes Lindemeyer

Medizinische Hochschule Brandenburg Theodor Fontane

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026