Clinical trial NCT02968537: Learning to Resist the Urge: Inhibition Training in Abstinent Patients With Alcohol Use Disorders
Official title: Learning to Resist the Urge: Inhibition Training in Abstinent Patients With Alcohol Use Disorders. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependence
Keywords: Alcohol use disorders
inhibition
EEG
cortisol
Training
clinical outcome measures
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Clinic Südhang
name: Forel Clinic
name: Psychiatric Center Muensingen
First posted: 2016-11-18
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)).

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.

Primary outcomes:
measure: Percent days of abstinence 3-months follow-up.
timeFrame: 3-months follow-up
measure: Inhibition Go/NoGo
timeFrame: Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session
measure: Neurophysiology of inhibitory Control (Go/NoGo)
timeFrame: Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session
measure: Implicit associations (IAT)
timeFrame: Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session
measure: Heavy drinking days in 3 months follow-up
timeFrame: 3 months follow-up
Secondary outcomes:
measure: Abstinence related self-efficacy
timeFrame: Post-training (i.e. between 1 and 7 days after completion of the training session); discharge, 3-, 6- and 12-months follow-up
measure: Craving
timeFrame: Post-training (i.e. between 1 and 7 days after completion of the last training session); discharge, 3-, 6- and 12-months follow-up
measure: Time to first drink
timeFrame: 3-, 6- and 12-months follow-up
measure: Percent heavy drinking days
timeFrame: 3-, 6- and 12-months follow-up
measure: Inhibition (SST)
timeFrame: Post-training; i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session
Other outcomes:
Locations:
city: Ellikon
country: Switzerland
facility: Forel Klinik
city: Kirchlindach
country: Switzerland
facility: Klinik Südhang
city: Münsingen
country: Switzerland
facility: Psychiatric Center Muensingen
Study officials:
affiliation: University of Bern, University Hospital for Psychiatry
name: Maria Stein, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern, University Hospital for Psychiatry
name: Leila Soravia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern, University Hospital for Psychiatry
name: Franz Moggi, PD
role: PRINCIPAL_INVESTIGATOR
References:
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.