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

NCT02968537 | Completed

• 1 other identifier: INTRA-2016-00988
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 3

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.

Conditions

Alcohol Dependence

Keywords

Alcohol use disorders; inhibition; EEG; cortisol; Training; clinical outcome measures

Outcome Measures

Primary Outcomes (5)

• Percent days of abstinence 3-months follow-up.

  Percentage of abstinent days in 3-months follow-up. This will be measured with the timeline follow back (TFB), which is a validated procedure to aid recall of past drinking and evaluates information about drinking behavior.

  3-months follow-up

• Inhibition Go/NoGo

  Inhibitory control as assessed with a Go/NoGo task.

  Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session

• Neurophysiology of inhibitory Control (Go/NoGo)

  Neurophysiological correlates of inhibitory control as assessed with EEG-measurement during the Go-NOGo-task. ERPs in response to NoGo-Stimuli will be calculated and the N2/p3-complex will be analyzed

  Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session

• Implicit associations (IAT)

  Implicit associations as assessed with an alcohol-related implicit association task (IAT)

  Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session

• Heavy drinking days in 3 months follow-up

  in 3-months follow-up. This will be measured Heavy drinking days in 3 months follow-up, measured with the timeline follow back (TFB), which is a validated procedure to aid recall of past drinking and evaluates information about drinking behavior.

  3 months follow-up

Secondary Outcomes (5)

• Abstinence related self-efficacy

  Post-training (i.e. between 1 and 7 days after completion of the training session); discharge, 3-, 6- and 12-months follow-up

• Craving

  Post-training (i.e. between 1 and 7 days after completion of the last training session); discharge, 3-, 6- and 12-months follow-up

• Time to first drink

  3-, 6- and 12-months follow-up

• Percent heavy drinking days

  3-, 6- and 12-months follow-up

• Inhibition (SST)

  Post-training; i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session

Study Arms (6)

Alc-IT (50/50) (morning)

EXPERIMENTAL

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.

Behavioral: Alc-IT (50/50) (morning)

Alc-IT (75/25) (morning)

EXPERIMENTAL

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.

Behavioral: Alc-IT (75/25) (morning)

Control-training (morning)

PLACEBO COMPARATOR

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.

Behavioral: Control-training (morning)

Alc-IT (50/50) (afternoon)

EXPERIMENTAL

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.

Behavioral: Alc-IT (50/50) (afternoon)

Alc-IT (75/25) (afternoon)

EXPERIMENTAL

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.

Behavioral: Alc-IT (75/25) (afternoon)

Control-training (afternoon)

PLACEBO COMPARATOR

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.

Behavioral: Control-training (afternoon)

Interventions

Alc-IT (50/50) (morning) 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 (50/50) (morning)

Alc-IT (75/25) (morning) 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.

Alc-IT (75/25) (morning)

Control-training (morning) 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.

Control-training (morning)

Alc-IT (50/50) (afternoon) 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 (50/50) (afternoon)

Alc-IT (75/25) (afternoon) 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.

Alc-IT (75/25) (afternoon)

Control-training (afternoon) 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.

Control-training (afternoon)

Eligibility Criteria

• Age: 18 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bern: lead
• Clinic Südhang: collaborator
• Forel Clinic: collaborator
• Psychiatric Center Muensingen: collaborator

Study Sites (3)

Forel Klinik

Ellikon, Switzerland

Location

Klinik Südhang

Kirchlindach, Switzerland

Location

Psychiatric Center Muensingen

Münsingen, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 31277683 DERIVED

MeSH Terms

Conditions

Alcoholism; Inhibition, Psychological

Condition Hierarchy (Ancestors)

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

Study Officials

• Maria Stein, PhD

  University of Bern, University Hospital for Psychiatry

  PRINCIPAL INVESTIGATOR

• Leila Soravia, PhD

  University of Bern, University Hospital for Psychiatry

  PRINCIPAL INVESTIGATOR

• Franz Moggi, PD

  University of Bern, University Hospital for Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: November 18, 2016
• Study Start: December 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: July 1, 2020
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3)