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Trial record 3 of 5 for:    Linden depression

Neurofeedback & Alcohol Dependence

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02486900
First Posted: July 1, 2015
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
European Commission
Information provided by (Responsible Party):
David Linden, Cardiff University
  Purpose
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.

Condition Intervention
Alcohol Dependence Device: fMRI-based neurofeedback

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Real-time fMRI Neurofeedback as a Treatment Tool for Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by David Linden, Cardiff University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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) ]

Estimated Enrollment: 52
Study Start Date: September 2015
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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).

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).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02486900


Locations
United Kingdom
School of Medicine, Cardiff University
Cardiff, Wales, United Kingdom, CF14 4XN
Sponsors and Collaborators
Cardiff University
European Commission
Investigators
Principal Investigator: David Linden, MD Cardiff University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Linden, Professor of Translational Neuroscience, Cardiff University
ClinicalTrials.gov Identifier: NCT02486900     History of Changes
Other Study ID Numbers: BRAINTRAINAD
First Submitted: June 26, 2015
First Posted: July 1, 2015
Last Update Posted: October 4, 2017
Last Verified: October 2017

Keywords provided by David Linden, Cardiff University:
Craving
Cue Reactivity
Neurofeedback

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs