Learning to Resist the Urge: Inhibition Training in Abstinent Patients With Alcohol Use Disorders

NCT ID: NCT02968537

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2020-07-31

Brief Summary

The study aims to investigate the effects of a short computerized training as a therapeutic add-on to standard therapy in patients with alcohol-use disorder.

Detailed Description

Therapeutic interventions to treat alcohol use disorders (AUD) still need to be improved. A novel alcohol-specific inhibition-training seems to be a promising new intervention. In this study, recently abstinent patients with AUD attending an inpatient treatment program will be randomly assigned to one of two alcohol-specific inhibition-training groups (varying in Go/NoGo-ratio) or to a control condition. Besides the effects on drinking behavior, inhibition and implicit attitudes, the investigators expect the training to influence neurophysiological reactivity to alcohol related stimuli. A subgroup of patients will therefore additionally undergo EEG recording so that the neurophysiological effects of the training can be assessed and related to clinical outcome. Furthermore, since training effects rely on learning processes, the influence of endogenous cortisol level (a consolidation-enhancer which peaks in the morning) on training outcome will be examined by the variation of daytime of the training. All patients' inhibitory control and implicit associations towards alcohol will be measured before and after training. The training effects will be examined on proximal outcome variables (e.g. implicit associations, inhibitory control, abstinence related self-efficacy, craving) and on distal outcome variables at 3-, 6- and 12- months follow-up (e.g. percent abstinent days (primary outcome)).

Conditions

Alcohol Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Alc-IT (50/50) (morning)

Alc-IT (50/50) (morning): This alcohol-specific inhibition-training (Alc-IT) training group will operate with a Go/NoGo ratio of 50/50 (Houben et al. 2011; 2012): This original version of the Alc-inhibition-training will include 80 alcoholic NoGo trials as well as 80 non-alcoholic Go trials. In order to arrive at the same training length while keeping the number of Alc-NoGo-pairings constant and the Go/NoGo-ratio at 50/50, it will additionally include 80 neutral Go-trials as well as 80 neutral NoGo-trials. It will thus consist of 320 trials and take about 10.5 minutes to be completed. In the morning group, this training will be administered within the first 2 hours after awakening.

Group Type: EXPERIMENTAL

Alc-IT (50/50) (morning)

Intervention Type: BEHAVIORAL

This alcohol-specific inhibition-training (Alc-IT) training group will operate with a Go/NoGo ratio of 50/50 (Houben et al. 2011; 2012): This original version of the Alc-inhibition-training will include 80 alcoholic NoGo trials as well as 80 non-alcoholic Go trials. In order to arrive at the same training length while keeping the number of Alc-NoGo-pairings constant and the Go/NoGo-ratio at 50/50, it will additionally include 80 neutral Go-trials as well as 80 neutral NoGo-trials. It will thus consist of 320 trials and take about 10.5 minutes to be completed. In the morning group, this training will be administered within the first 2 hours after awakening.

Alc-IT (75/25) (morning)

This version of the alcohol-specific inhibition-training (Alc-IT) will operate with a Go/NoGo-ratio of 75/25. It will equally include 80 Alcoholic NoGo-trials and 80 non-alcoholic Go-trials, but now 160 neutral Go-trials will complete the set. This training will also consist of 320 trials and take about 10.5 minutes. In the morning group, this training will be administered within the first 2 hours after awakening.

Group Type: EXPERIMENTAL

Alc-IT (75/25) (morning)

Intervention Type: BEHAVIORAL

This version of the alcohol-specific inhibition-training (Alc-IT) will operate with a Go/NoGo-ratio of 75/25. It will equally include 80 Alcoholic NoGo-trials and 80 non-alcoholic Go-trials, but now 160 neutral Go-trials will complete the set. This training will also consist of 320 trials and take about 10.5 minutes. In the morning group, this training will be administered within the first 2 hours after awakening.

Control-training (morning)

This group will receive an unspecific inhibition training. this training is of the same length and difficulty as the two Alc-inhibition-trainings. In the morning group, this training will be administered within the first 2 hours after awakening.

Group Type: PLACEBO_COMPARATOR

Control-training (morning)

Intervention Type: BEHAVIORAL

This group will receive an unspecific inhibition training. this training is of the same length and difficulty as the two Alc-inhibition-trainings. In the morning group, this training will be administered within the first 2 hours after awakening.

Alc-IT (50/50) (afternoon)

Alc-IT (50/50) (afternoon): As in the arm "Alc-IT (50/50) (morning)", this alcohol-specific inhibition-training (Alc-IT) group will operate with a Go/NoGo ratio of 50/50 (Houben et al. 2011; 2012): This original version of the Alc-inhibition-training will include 80 alcoholic NoGo trials as well as 80 non-alcoholic Go trials. In order to arrive at the same training length while keeping the number of Alc-NoGo-pairings constant and the Go/NoGo-ratio at 50/50, it will additionally include 80 neutral Go-trials as well as 80 neutral NoGo-trials. It will thus consist of 320 trials and take about 10.5 minutes to be completed. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon.

Group Type: EXPERIMENTAL

Alc-IT (50/50) (afternoon)

Intervention Type: BEHAVIORAL

As in the arm "Alc-IT (50/50) (morning)", this alcohol-specific inhibition-training (Alc-IT) group will operate with a Go/NoGo ratio of 50/50 (Houben et al. 2011; 2012): This original version of the Alc-inhibition-training will include 80 alcoholic NoGo trials as well as 80 non-alcoholic Go trials. In order to arrive at the same training length while keeping the number of Alc-NoGo-pairings constant and the Go/NoGo-ratio at 50/50, it will additionally include 80 neutral Go-trials as well as 80 neutral NoGo-trials. It will thus consist of 320 trials and take about 10.5 minutes to be completed. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon.

Alc-IT (75/25) (afternoon)

As in the arm "Alc-IT (75/25) (morning)", this version of the alcohol-specific inhibition-training (Alc-IT) will operate with a Go/NoGo-ratio of 75/25. It will equally include 80 Alcoholic NoGo-trials and 80 non-alcoholic Go-trials, but now 160 neutral Go-trials will complete the set. This training will also consist of 320 trials and take about 10.5 minutes. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon.

Group Type: EXPERIMENTAL

Alc-IT (75/25) (afternoon)

Intervention Type: BEHAVIORAL

As in the arm "Alc-IT (75/25) (morning)", this version of the alcohol-specific inhibition-training (Alc-IT) will operate with a Go/NoGo-ratio of 75/25. It will equally include 80 Alcoholic NoGo-trials and 80 non-alcoholic Go-trials, but now 160 neutral Go-trials will complete the set. This training will also consist of 320 trials and take about 10.5 minutes. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon.

Control-training (afternoon)

As in the arm "Control-training (morning), this group will receive an unspecific inhibition training. This training is of the same length and difficulty as the two Alc-inhibition-trainings. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon.

Group Type: PLACEBO_COMPARATOR

Control-training (afternoon)

Intervention Type: BEHAVIORAL

As in the arm "Control-training (morning), this group will receive an unspecific inhibition training. This training is of the same length and difficulty as the two Alc-inhibition-trainings. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon.

Interventions

Alc-IT (50/50) (morning)

This alcohol-specific inhibition-training (Alc-IT) training group will operate with a Go/NoGo ratio of 50/50 (Houben et al. 2011; 2012): This original version of the Alc-inhibition-training will include 80 alcoholic NoGo trials as well as 80 non-alcoholic Go trials. In order to arrive at the same training length while keeping the number of Alc-NoGo-pairings constant and the Go/NoGo-ratio at 50/50, it will additionally include 80 neutral Go-trials as well as 80 neutral NoGo-trials. It will thus consist of 320 trials and take about 10.5 minutes to be completed. In the morning group, this training will be administered within the first 2 hours after awakening.

Intervention Type: BEHAVIORAL

Alc-IT (75/25) (morning)

This version of the alcohol-specific inhibition-training (Alc-IT) will operate with a Go/NoGo-ratio of 75/25. It will equally include 80 Alcoholic NoGo-trials and 80 non-alcoholic Go-trials, but now 160 neutral Go-trials will complete the set. This training will also consist of 320 trials and take about 10.5 minutes. In the morning group, this training will be administered within the first 2 hours after awakening.

Intervention Type: BEHAVIORAL

Control-training (morning)

This group will receive an unspecific inhibition training. this training is of the same length and difficulty as the two Alc-inhibition-trainings. In the morning group, this training will be administered within the first 2 hours after awakening.

Intervention Type: BEHAVIORAL

Alc-IT (50/50) (afternoon)

As in the arm "Alc-IT (50/50) (morning)", this alcohol-specific inhibition-training (Alc-IT) group will operate with a Go/NoGo ratio of 50/50 (Houben et al. 2011; 2012): This original version of the Alc-inhibition-training will include 80 alcoholic NoGo trials as well as 80 non-alcoholic Go trials. In order to arrive at the same training length while keeping the number of Alc-NoGo-pairings constant and the Go/NoGo-ratio at 50/50, it will additionally include 80 neutral Go-trials as well as 80 neutral NoGo-trials. It will thus consist of 320 trials and take about 10.5 minutes to be completed. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon.

Intervention Type: BEHAVIORAL

Alc-IT (75/25) (afternoon)

As in the arm "Alc-IT (75/25) (morning)", this version of the alcohol-specific inhibition-training (Alc-IT) will operate with a Go/NoGo-ratio of 75/25. It will equally include 80 Alcoholic NoGo-trials and 80 non-alcoholic Go-trials, but now 160 neutral Go-trials will complete the set. This training will also consist of 320 trials and take about 10.5 minutes. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon.

Intervention Type: BEHAVIORAL

Control-training (afternoon)

As in the arm "Control-training (morning), this group will receive an unspecific inhibition training. This training is of the same length and difficulty as the two Alc-inhibition-trainings. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Abstinent patients with an alcohol use disorder in the 12-week inpatient program of the Clinic Südhang or the Forel Clinic,
• Abstained from alcohol for at least 4 weeks (in relation to timepoint when training will start),
• Informed Consent as documented by signature.

Exclusion Criteria

• Other main psychiatric diagnosis than alcohol use disorder (comorbidity is allowed if the alcohol use disorder is to be considered the main diagnosis),
• other severe substance use disorder (except nicotine), even as secondary diagnosis
• Neurocognitive problems (e.g. Korsakoff syndrome),
• Current medical conditions excluding participation (e.g. acute infectious disease),
• Inability to read and understand the participant's information,
• Enrolment of the investigator, his/her family members, employees and other dependent persons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinic Südhang

UNKNOWN

Sponsor Role: collaborator

Forel Clinic

OTHER

Sponsor Role: collaborator

Psychiatric Center Muensingen

UNKNOWN

Sponsor Role: collaborator

University of Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Stein, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bern, University Hospital for Psychiatry

Leila Soravia, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bern, University Hospital for Psychiatry

Franz Moggi, PD

Role: PRINCIPAL_INVESTIGATOR

University of Bern, University Hospital for Psychiatry

Locations

Forel Klinik

Ellikon, , Switzerland

Klinik Südhang

Kirchlindach, , Switzerland

Psychiatric Center Muensingen

Münsingen, , Switzerland

Countries

Switzerland

References

Tschuemperlin RM, Stein M, Batschelet HM, Moggi F, Soravia LM. Learning to resist the urge: a double-blind, randomized controlled trial investigating alcohol-specific inhibition training in abstinent patients with alcohol use disorder. Trials. 2019 Jul 5;20(1):402. doi: 10.1186/s13063-019-3505-2.

Reference Type: DERIVED

PMID: 31277683 (View on PubMed)

Other Identifiers

INTRA-2016-00988

Identifier Type: -

Identifier Source: org_study_id