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Neurofeedback & Alcohol Dependence

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
fMRI-based neurofeedback
Sponsored by
Cardiff University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Craving, Cue Reactivity, Neurofeedback

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School of Medicine, Cardiff University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Neurofeedback training group

Treatment-as-usual control group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Indices of drinking (continuous) - % days abstinent
Derived from the Timeline Followback Calendar.
Indices of drinking (continuous) - drinks per drinking day
Derived from the Timeline Followback Calendar.
Indices of drinking (continuous) - % days of 'heavy drinking'
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)
Drinking urges/craving assessed with the Obsessive Compulsive Drinking Scale (OCDS)
Drinking urges/craving (attentional bias) assessed with the alcohol stroop test
Craving self-ratings during scanning (neurofeedback group only)
Profile of Mood States Questionnaire
Beck Depression Inventory
Hospital Anxiety and Depression Scale
NHS Resource Use Questionnaire
Debriefing Questionnaire (neurofeedback group only)

Full Information

First Posted
June 26, 2015
Last Updated
January 31, 2019
Sponsor
Cardiff University
Collaborators
European Commission
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1. Study Identification

Unique Protocol Identification Number
NCT02486900
Brief Title
Neurofeedback & Alcohol Dependence
Official Title
Real-time fMRI Neurofeedback as a Treatment Tool for Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardiff University
Collaborators
European Commission

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Craving, Cue Reactivity, Neurofeedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurofeedback training group
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment-as-usual control group
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
fMRI-based neurofeedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Indices of drinking (continuous) - % days abstinent
Description
Derived from the Timeline Followback Calendar.
Time Frame
4 months after baseline assessment/first training
Title
Indices of drinking (continuous) - drinks per drinking day
Description
Derived from the Timeline Followback Calendar.
Time Frame
4 months after baseline assessment/first training
Title
Indices of drinking (continuous) - % days of 'heavy drinking'
Description
Defined as 8 or more alcohol units per day/men or 6 or more units/women. Derived from the Timeline Followback Calendar.
Time Frame
4 months after baseline assessment/first training
Secondary Outcome Measure Information:
Title
Drinking urges/craving assessed with the Drinking Urges Questionnaire (DUQ)
Time Frame
Assessed 4 months, 8 months and 12 months after baseline
Title
Drinking urges/craving assessed with the Obsessive Compulsive Drinking Scale (OCDS)
Time Frame
Assessed 4 months, 8 months and 12 months after baseline
Title
Drinking urges/craving (attentional bias) assessed with the alcohol stroop test
Time Frame
Assessed 4 months, 8 months and 12 months after baseline
Title
Craving self-ratings during scanning (neurofeedback group only)
Time Frame
Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session)
Title
Profile of Mood States Questionnaire
Time Frame
Assessed 4 months, 8 months and 12 months after baseline
Title
Beck Depression Inventory
Time Frame
Assessed 4 months, 8 months and 12 months after baseline
Title
Hospital Anxiety and Depression Scale
Time Frame
Assessed 4 months, 8 months and 12 months after baseline
Title
NHS Resource Use Questionnaire
Time Frame
Assessed 4 months, 8 months and 12 months after baseline
Title
Debriefing Questionnaire (neurofeedback group only)
Time Frame
Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Linden, MD
Organizational Affiliation
Cardiff University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Medicine, Cardiff University
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27716290
Citation
Cox WM, Subramanian L, Linden DE, Luhrs 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. doi: 10.1186/s13063-016-1607-7.
Results Reference
derived

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Neurofeedback & Alcohol Dependence

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