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

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ClinicalTrials.gov Identifier: NCT02968537
Recruitment Status : Active, not recruiting
First Posted : November 18, 2016
Last Update Posted : May 5, 2020
Sponsor:
Collaborators:
Clinic Südhang
Forel Clinic
Psychiatric Center Muensingen
Information provided by (Responsible Party):
University of Bern

Tracking Information
First Submitted Date  ICMJE November 10, 2016
First Posted Date  ICMJE November 18, 2016
Last Update Posted Date May 5, 2020
Study Start Date  ICMJE December 2016
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • Percent days of abstinence 3-months follow-up. [ Time Frame: 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 [ Time Frame: Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session ]
    Inhibitory control as assessed with a Go/NoGo task.
  • Neurophysiology of inhibitory Control (Go/NoGo) [ Time Frame: Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session ]
    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) [ Time Frame: Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session ]
    Implicit associations as assessed with an alcohol-related implicit association task (IAT)
  • Heavy drinking days in 3 months follow-up [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 15, 2016)
  • Percent days of abstinence 3-months follow-up. [ Time Frame: 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 [ Time Frame: Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session ]
    Inhibitory control as assessed with a Go/NoGo task.
  • Neurophysiology of inhibitory Control (Go/NoGo) [ Time Frame: Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session ]
    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) [ Time Frame: Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session ]
    Implicit associations as assessed with an alcohol-related implicit association task (IAT)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2016)
  • Abstinence related self-efficacy [ 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 ]
    Self efficacy will be assessed with the alcohol abstinence self-efficacy scale (AASE).
  • Craving [ 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 ]
    Craving will be measured with the German version of the Obsessive compulsive drinking scale (OCDS-G).
  • Time to first drink [ Time Frame: 3-, 6- and 12-months follow-up ]
  • Percent heavy drinking days [ Time Frame: 3-, 6- and 12-months follow-up ]
  • Inhibition (SST) [ Time Frame: Post-training; i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session ]
    Inhibitory control will be assessed with a Stop-Signal task
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Learning to Resist the Urge: Inhibition Training in Abstinent Patients With Alcohol Use Disorders
Official Title  ICMJE Learning to Resist the Urge: Inhibition Training in Abstinent Patients With Alcohol Use Disorders. A Randomized Controlled Trial
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)).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Dependence
Intervention  ICMJE
  • Behavioral: 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 (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.
  • 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.
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Alc-IT (50/50) (morning)
  • Experimental: 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: Behavioral: Alc-IT (75/25) (morning)
  • Placebo Comparator: 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: Behavioral: Control-training (morning)
  • Experimental: 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.
    Intervention: Behavioral: Alc-IT (50/50) (afternoon)
  • Experimental: 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: Behavioral: Alc-IT (75/25) (afternoon)
  • Placebo Comparator: 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: Behavioral: Control-training (afternoon)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 15, 2016)
246
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 18 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02968537
Other Study ID Numbers  ICMJE INTRA-2016-00988
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Bern
Study Sponsor  ICMJE University of Bern
Collaborators  ICMJE
  • Clinic Südhang
  • Forel Clinic
  • Psychiatric Center Muensingen
Investigators  ICMJE
Principal Investigator: 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
PRS Account University of Bern
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP