Alcohol DependenceSPIRANCT03952429
A Smartphone Based Intervention for the Prevention of Relapse in Alcohol Dependence
A study testing Anti Alcohol App with Active Cognitive Bias and Inactive Cognitive Bias Modification in people with Alcohol Dependence and Alcohol Abuse, run by Salus Klinik Lindow at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Dependence, Alcohol Abuse, Alcohol Use Disorder
- What is being tested?
- Anti Alcohol App with Active Cognitive Bias and Inactive Cognitive Bias Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- 23 May 2019to 27 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Visual or motor impairments that would affect the use of smartphones
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Dependence, Alcohol Abuse, Alcohol Use Disorder
- Being tested
- Anti Alcohol App with Active Cognitive Bias, Inactive Cognitive Bias Modification
- Keywords
- alcohol dependence, alcohol abuse, withdrawal
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti Alcohol App with Active Cognitive BiasBehavioural
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.
Inactive Cognitive Bias ModificationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Cognitive Bias App | Active comparator | Participants will receive the Anti-Alcohol App with the Active Cognitive Bias modification, as well as participant diaries assessing alcohol consumption and several questionnaires. Receives: Behavioral: Anti Alcohol App with Active Cognitive Bias |
| Inactive Cognitive Bias Modification | Placebo comparator | Participants will receive the Anti-Alcohol App with the Inactive Cognitive Bias Modification, as well as participant diaries assessing alcohol consumption and several questionnaires. Receives: Behavioral: Inactive Cognitive Bias Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse Rates
Relapse rates after leaving inpatient care, assessed through standard clinic follow-ups
Measured: 3 months after care, 1 year after care
App Usage
Number of times App training has been completed
Measured: within 3 months after leaving care
Craving
Craving for alcohol assessed in app, 5 point likert scale with alcohol images, OCDS
Measured: after 5 training sessions of the app
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start23 May 2019
- Primary completion27 Oct 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salus Klinik Lindow
- Sponsor type
- Research network
- Collaborators
- University of Cambridge
- Responsible party
- Sponsor
- Investigators
- Prof Johannes Lindemeyer, Principal investigator, Medizinische Hochschule Brandenburg Theodor Fontane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952429
- Sponsor's protocol ID
- SPIRA
- Acronym
- SPIRA
- Status last verified
- Apr 2026
- First submitted
- 10 May 2019
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised participant data will be shared with the collaborators at Cambridge University
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPIRA: Development of a Smartphone Based Intervention for the Prevention of Relapse in Alcohol Dependence
- ClinicalTrials.gov ID
- NCT03952429
- Acronym / sponsor ID
- SPIRA / SPIRA
- Conditions
- Alcohol Dependence, Alcohol Abuse, Alcohol Use Disorder
- Keywords
- alcohol dependence, alcohol abuse, withdrawal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Salus Klinik LindowResearch network
- Collaborators
- University of Cambridge
- Study start
- 23 May 2019 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Active Cognitive Bias App | Active comparator | Behavioral: Anti Alcohol App with Active Cognitive BiasParticipants will receive the Anti-Alcohol App with the Active Cognitive Bias modification, as well as participant diaries assessing alcohol consumption and several questionnaires. |
| Inactive Cognitive Bias Modification | Placebo comparator | Behavioral: Inactive Cognitive Bias ModificationParticipants will receive the Anti-Alcohol App with the Inactive Cognitive Bias Modification, as well as participant diaries assessing alcohol consumption and several questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Visual or motor impairments that would affect the use of smartphones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti Alcohol App with Active Cognitive BiasThe 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. | Behavioural | Active Cognitive Bias App |
| Inactive Cognitive Bias ModificationThe 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. | Behavioural | Inactive Cognitive Bias Modification |
Primary outcome
Relapse Rates
Time frame: 3 months after care, 1 year after care
Relapse rates after leaving inpatient care, assessed through standard clinic follow-ups
App Usage
Time frame: within 3 months after leaving care
Number of times App training has been completed
Craving
Time frame: after 5 training sessions of the app
Craving for alcohol assessed in app, 5 point likert scale with alcohol images, OCDS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Yes. Anonymised participant data will be shared with the collaborators at Cambridge University
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Johannes Lindemeyer principal investigator
Medizinische Hochschule Brandenburg Theodor Fontane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti Alcohol App with Active Cognitive Bias and Inactive Cognitive Bias Modification in people with Alcohol Dependence and Alcohol Abuse, run by Salus Klinik Lindow at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse Rates (time frame: 3 months after care, 1 year after care). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.