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Neurofeedback & Alcohol Dependence

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ClinicalTrials.gov Identifier: NCT02486900
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
David Linden, Cardiff University

Tracking Information
First Submitted Date  ICMJE June 26, 2015
First Posted Date  ICMJE July 1, 2015
Last Update Posted Date February 1, 2019
Study Start Date  ICMJE September 2015
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2015)
  • Indices of drinking (continuous) - % days abstinent [ Time Frame: 4 months after baseline assessment/first training ]
    Derived from the Timeline Followback Calendar.
  • Indices of drinking (continuous) - drinks per drinking day [ Time Frame: 4 months after baseline assessment/first training ]
    Derived from the Timeline Followback Calendar.
  • Indices of drinking (continuous) - % days of 'heavy drinking' [ Time Frame: 4 months after baseline assessment/first training ]
    Defined as 8 or more alcohol units per day/men or 6 or more units/women. Derived from the Timeline Followback Calendar.
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2015)
Abstinence rate (binary) [ Time Frame: Across 12 months after baseline assessment/first training ]
Abstinence rate will be derived from the Typical and Atypical Drinking Diary (TADD) and assessed at the final session (12 months after baseline)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2015)
  • Drinking urges/craving assessed with the Drinking Urges Questionnaire (DUQ) [ Time Frame: Assessed 4 months, 8 months and 12 months after baseline ]
  • Drinking urges/craving assessed with the Obsessive Compulsive Drinking Scale (OCDS) [ Time Frame: Assessed 4 months, 8 months and 12 months after baseline ]
  • Drinking urges/craving (attentional bias) assessed with the alcohol stroop test [ Time Frame: Assessed 4 months, 8 months and 12 months after baseline ]
  • Craving self-ratings during scanning (neurofeedback group only) [ Time Frame: Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session) ]
  • Profile of Mood States Questionnaire [ Time Frame: Assessed 4 months, 8 months and 12 months after baseline ]
  • Beck Depression Inventory [ Time Frame: Assessed 4 months, 8 months and 12 months after baseline ]
  • Hospital Anxiety and Depression Scale [ Time Frame: Assessed 4 months, 8 months and 12 months after baseline ]
  • NHS Resource Use Questionnaire [ Time Frame: Assessed 4 months, 8 months and 12 months after baseline ]
  • Debriefing Questionnaire (neurofeedback group only) [ Time Frame: Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2015)
  • Alcohol consumption assessed with the Typical and Atypical Drinking Diary [ Time Frame: Assessed 4 months, 8 months and 12 months after baseline ]
    Measured retrospectively as average weekly consumption since the last session
  • Drinking urges/craving assessed with the Drinking Urges Questionnaire (DUQ) [ Time Frame: Assessed 4 months, 8 months and 12 months after baseline ]
  • Drinking urges/craving assessed with the Obsessive Compulsive Drinking Scale (OCDS) [ Time Frame: Assessed 4 months, 8 months and 12 months after baseline ]
  • Drinking urges/craving (attentional bias) assessed with the alcohol stroop test [ Time Frame: Assessed 4 months, 8 months and 12 months after baseline ]
  • Craving self-ratings during scanning (neurofeedback group only) [ Time Frame: Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neurofeedback & Alcohol Dependence
Official Title  ICMJE Real-time fMRI Neurofeedback as a Treatment Tool for Alcohol Dependence
Brief Summary The study aims to examine whether the neurofeedback method (based on functional magnetic resonance imaging [fMRI]) can help patients with alcohol dependence to control their urges to drink alcohol and thus to remain abstinent. Potential effects of neurofeedback on abstinence and drinking behaviour will be evaluated based on the comparison between a group of patients receiving multiple sessions of neurofeedback training and a group of patients receiving treatment as usual over the same period of time.
Detailed Description Neurofeedback is a non-invasive neuroscientific tool in which participants receive real-time feedback about their brain activity while undergoing functional magnetic resonance imaging. Previous research has shown that participants can successfully use the feedback to self-regulate their brain responses. In this study patients who have successfully completed a detoxification programme will be trained to down-regulate/upregulate responses of motivational brain regions that are activated during exposure to alcohol/life goal-related stimuli (pictures of alcoholic drinks/life goals related). The investigators hypothesise that learning to self-regulate these neural responses will enable patients to better control craving responses to environmental alcohol cues after detoxification treatment. Patients in the intervention group will undergo 6 neurofeedback training sessions, spread across 4 months. Outcomes of the training will be compared with a group of patients who will not do the neurofeedback training but receive standard treatment (e.g. support groups and medication).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Dependence
Intervention  ICMJE Device: fMRI-based neurofeedback
During scanning patients will be exposed to picture stimuli (showing alcoholic drinks and life goals) projected on a screen behind the scanner and viewed through a mirror attached on the MRI head coil. In each session patients will be trained to down-regulate/up-regulate activation levels in brain areas that show reliable responses to the alcohol/life goals pictures in a 'localiser' scan. Self-regulation of these brain responses will then be guided by real-time feedback of alcohol/life goals-cue elicited activation, consisting of changes in the visible alcohol/life goals picture (decreasing size = successful down-regulation; increasing size = successful upregulation). Functional MRI data will be acquired in short blocks having a duration of 5-8 minutes.
Study Arms  ICMJE
  • Experimental: Neurofeedback training group
    The neurofeedback group will perform 6 training sessions over a period of 4 months: 4 fortnightly sessions in the first two months will be followed by 2 monthly 'booster' sessions. Each session will include several behavioural assessments and fMRI-based neurofeedback training in an MRI scanner (1 h). The neurofeedback training phase will be be followed-up by two behavioural assessments 8 and 12 months after the first training.
    Intervention: Device: fMRI-based neurofeedback
  • No Intervention: Treatment-as-usual control group
    The control group will receive treatment as usual (e.g. medication, counselling) but no neurofeedback training during the study period. Patients in the control group will be invited for four behavioural assessment sessions (baseline assessment, follow-up assessments 4/8/12 months after baseline).
Publications * Cox WM, Subramanian L, Linden DE, Lührs M, McNamara R, Playle R, Hood K, Watson G, Whittaker JR, Sakhuja R, Ihssen N. Neurofeedback training for alcohol dependence versus treatment as usual: study protocol for a randomized controlled trial. Trials. 2016 Oct 3;17(1):480.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2017)
52
Original Estimated Enrollment  ICMJE
 (submitted: June 30, 2015)
50
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Successful completion of detoxification programme within a time window of 1 to 6 months before the recruitment
  • Abstinence since detoxification treatment

Exclusion Criteria:

  • Ongoing regular abuse of illicit substances except cannabis
  • History of psychotic disorders not related to alcohol
  • IQ < 70
  • Involvement in other interventional research in the past 6 months
  • MRI counter-indications, e.g. claustrophobia, pregnancy, active medical implants, passive implants deemed unsuitable, metallic dust in the eyes, certain types of metal prostheses, surgical clips, previous experience with metalworking without eye protection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02486900
Other Study ID Numbers  ICMJE BRAINTRAINAD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Linden, Cardiff University
Study Sponsor  ICMJE Cardiff University
Collaborators  ICMJE European Commission
Investigators  ICMJE
Principal Investigator: David Linden, MD Cardiff University
PRS Account Cardiff University
Verification Date January 2019

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