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

Primary Purpose

Alcohol Dependence

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Alc-IT (50/50) (morning)

Alc-IT (75/25) (morning)

Control-training (morning)

Alc-IT (50/50) (afternoon)

Alc-IT (75/25) (afternoon)

Control-training (afternoon)

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol use disorders, inhibition, EEG, cortisol, Training, clinical outcome measures

Eligibility Criteria

18 Years - 18 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Forel Klinik
Klinik Südhang
Psychiatric Center Muensingen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Alc-IT (50/50) (morning)

Alc-IT (75/25) (morning)

Control-training (morning)

Alc-IT (50/50) (afternoon)

Alc-IT (75/25) (afternoon)

Control-training (afternoon)

Arm Description

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.

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.

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): 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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Inhibition Go/NoGo

Inhibitory control as assessed with a Go/NoGo task.

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

Implicit associations (IAT)

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

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.

Secondary Outcome Measures

Abstinence related self-efficacy

Self efficacy will be assessed with the alcohol abstinence self-efficacy scale (AASE).

Craving

Craving will be measured with the German version of the Obsessive compulsive drinking scale (OCDS-G).

Time to first drink

Percent heavy drinking days

Inhibition (SST)

Inhibitory control will be assessed with a Stop-Signal task

Full Information

NCT ID

NCT02968537

First Posted

November 10, 2016

Last Updated

May 3, 2022

Sponsor

University of Bern

Collaborators

Clinic Südhang, Forel Clinic, Psychiatric Center Muensingen

1. Study Identification

Unique Protocol Identification Number

NCT02968537

Brief Title

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

Acronym

INTRA

Official Title

Learning to Resist the Urge: Inhibition Training in Abstinent Patients With Alcohol Use Disorders. A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

December 2016 (Actual)

Primary Completion Date

September 2019 (Actual)

Study Completion Date

July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Bern

Collaborators

Clinic Südhang, Forel Clinic, Psychiatric Center Muensingen

4. Oversight

Data Monitoring Committee

5. Study Description

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)).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Dependence

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

242 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alc-IT (50/50) (morning)

Arm Type

Experimental

Arm Description

Arm Title

Alc-IT (75/25) (morning)

Arm Type

Experimental

Arm Description

Arm Title

Control-training (morning)

Arm Type

Placebo Comparator

Arm Description

Arm Title

Alc-IT (50/50) (afternoon)

Arm Type

Experimental

Arm Description

Arm Title

Alc-IT (75/25) (afternoon)

Arm Type

Experimental

Arm Description

Arm Title

Control-training (afternoon)

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Alc-IT (50/50) (morning)

Intervention Description

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

Intervention Name(s)

Alc-IT (75/25) (morning)

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Control-training (morning)

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Alc-IT (50/50) (afternoon)

Intervention Description

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

Intervention Name(s)

Alc-IT (75/25) (afternoon)

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Control-training (afternoon)

Intervention Description

Primary Outcome Measure Information:

Title

Percent days of abstinence 3-months follow-up.

Description

Time Frame

3-months follow-up

Title

Inhibition Go/NoGo

Description

Inhibitory control as assessed with a Go/NoGo task.

Time Frame

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

Title

Neurophysiology of inhibitory Control (Go/NoGo)

Description

Time Frame

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

Title

Implicit associations (IAT)

Description

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

Time Frame

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

Title

Heavy drinking days in 3 months follow-up

Description

Time Frame

3 months follow-up

Secondary Outcome Measure Information:

Title

Abstinence related self-efficacy

Description

Self efficacy will be assessed with the alcohol abstinence self-efficacy scale (AASE).

Time Frame

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

Title

Craving

Description

Craving will be measured with the German version of the Obsessive compulsive drinking scale (OCDS-G).

Time Frame

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

Title

Time to first drink

Time Frame

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

Title

Percent heavy drinking days

Time Frame

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

Title

Inhibition (SST)

Description

Inhibitory control will be assessed with a Stop-Signal task

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Stein, PhD

Organizational Affiliation

University of Bern, University Hospital for Psychiatry

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Leila Soravia, PhD

Organizational Affiliation

University of Bern, University Hospital for Psychiatry

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Franz Moggi, PD

Organizational Affiliation

University of Bern, University Hospital for Psychiatry

Official's Role

Principal Investigator

Facility Information:

Facility Name

Forel Klinik

City

Ellikon

Country

Switzerland

Facility Name

Klinik Südhang

City

Kirchlindach

Country

Switzerland

Facility Name

Psychiatric Center Muensingen

City

Münsingen

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31277683

Citation

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.

Results Reference

derived

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

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