Trial record 3 of 5 for:    Linden depression

Neurofeedback & Alcohol Dependence

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Cardiff University
European Commission
Information provided by (Responsible Party):
David Linden, Cardiff University Identifier:
First received: June 26, 2015
Last updated: November 9, 2015
Last verified: November 2015
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Cardiff University:

Primary Outcome Measures:
  • Indices of drinking (continuous) - % days abstinent [ Time Frame: 4 months after baseline assessment/first training ] [ Designated as safety issue: No ]
    Derived from the Timeline Followback Calendar.

  • Indices of drinking (continuous) - drinks per drinking day [ Time Frame: 4 months after baseline assessment/first training ] [ Designated as safety issue: No ]
    Derived from the Timeline Followback Calendar.

  • Indices of drinking (continuous) - % days of 'heavy drinking' [ Time Frame: 4 months after baseline assessment/first training ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Drinking urges/craving assessed with the Obsessive Compulsive Drinking Scale (OCDS) [ Time Frame: Assessed 4 months, 8 months and 12 months after baseline ] [ Designated as safety issue: No ]
  • Drinking urges/craving (attentional bias) assessed with the alcohol stroop test [ Time Frame: Assessed 4 months, 8 months and 12 months after baseline ] [ Designated as safety issue: No ]
  • Craving self-ratings during scanning (neurofeedback group only) [ Time Frame: Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session) ] [ Designated as safety issue: No ]
  • Profile of Mood States Questionnaire [ Time Frame: Assessed 4 months, 8 months and 12 months after baseline ] [ Designated as safety issue: No ]
  • Beck Depression Inventory [ Time Frame: Assessed 4 months, 8 months and 12 months after baseline ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale [ Time Frame: Assessed 4 months, 8 months and 12 months after baseline ] [ Designated as safety issue: No ]
  • NHS Resource Use Questionnaire [ Time Frame: Assessed 4 months, 8 months and 12 months after baseline ] [ Designated as safety issue: No ]
  • Debriefing Questionnaire (neurofeedback group only) [ Time Frame: Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session) ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2015
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: December 2016 (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).

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02486900

Contact: David Linden, MD
Contact: Leena Subramanian, PhD

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

No publications provided

Responsible Party: David Linden, Professor of Translational Neuroscience, Cardiff University Identifier: NCT02486900     History of Changes
Other Study ID Numbers: BRAINTRAINAD
Study First Received: June 26, 2015
Last Updated: November 9, 2015
Health Authority: United Kingdom: National Institute for Social Care and Health Research

Keywords provided by Cardiff University:
Cue Reactivity

Additional relevant MeSH terms:
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders processed this record on November 24, 2015