Neurofeedback as a Treatment Tool for Depression (NFD)
Primary Purpose
Unipolar Depression
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
fMRI-based neurofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Unipolar Depression
Eligibility Criteria
Inclusion Criteria:
- major depressive disorder (MDD) diagnosis
- stable antidepressant dose medication
Exclusion Criteria:
- Other physical or psychiatric disorders
- Current substance abuse
- Current psychotherapy or other specific intervention
- Exclusion criteria applicable to MRI
Sites / Locations
- CUBRIC
- School of Medicine, Cardiff University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Emotion network up-regulation
Place processing network up-regulation
Arm Description
Participants use fMRI-based neurofeedback to train the upregulation of brain areas that respond to positive affective pictures (as identified during a functional localiser scan).
Participants use fMRI-based neurofeedback to train the upregulation of brain areas that respond to place and house pictures (as identified during a functional localiser scan).
Outcomes
Primary Outcome Measures
Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at the end of intervention (after 5th session)
Secondary Outcome Measures
Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at follow-up
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) anxiety score at the end of intervention (after 5th session)
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) anxiety score at follow-up
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) depression score at the end of intervention (after 5th session)
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) depression score at follow-up
Change from Baseline in the Quality of Life Scale (QOLS) at the end of intervention (after 5th session)
Change from Baseline in the Quality of Life Scale (QOLS) at follow-up
Change from Baseline in the European Quality of Life-5 dimensions scale (EQ-5D) at the end of intervention (after 5th session)
Change from Baseline in the European Quality of Life-5 dimensions scale (EQ-5D) at follow-up
Full Information
NCT ID
NCT01544205
First Posted
February 23, 2012
Last Updated
December 13, 2016
Sponsor
Cardiff University
Collaborators
Medical Research Council, National Institute for Social Care and Health Research
1. Study Identification
Unique Protocol Identification Number
NCT01544205
Brief Title
Neurofeedback as a Treatment Tool for Depression
Acronym
NFD
Official Title
fMRI Based Neurofeedback as a Treatment Method for Depression
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardiff University
Collaborators
Medical Research Council, National Institute for Social Care and Health Research
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to investigate whether neurofeedback delivered via functional magnetic resonance imaging signals can be used to train depressed patients to self-regulate emotion networks and whether this improves clinical symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unipolar Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Emotion network up-regulation
Arm Type
Experimental
Arm Description
Participants use fMRI-based neurofeedback to train the upregulation of brain areas that respond to positive affective pictures (as identified during a functional localiser scan).
Arm Title
Place processing network up-regulation
Arm Type
Active Comparator
Arm Description
Participants use fMRI-based neurofeedback to train the upregulation of brain areas that respond to place and house pictures (as identified during a functional localiser scan).
Intervention Type
Other
Intervention Name(s)
fMRI-based neurofeedback
Intervention Description
5 sessions lasting one hour each
Primary Outcome Measure Information:
Title
Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at the end of intervention (after 5th session)
Time Frame
Before start trial (baseline), after intervention (appr. 2 months)
Secondary Outcome Measure Information:
Title
Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at follow-up
Time Frame
Baseline, 3-month follow-up
Title
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) anxiety score at the end of intervention (after 5th session)
Time Frame
Baseline, end of intervention (appr. 2 months)
Title
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) anxiety score at follow-up
Time Frame
Baseline, 3-month follow-up
Title
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) depression score at the end of intervention (after 5th session)
Time Frame
Baseline, end of intervention (appr. 2 months)
Title
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) depression score at follow-up
Time Frame
Baseline, 3-month follow-up
Title
Change from Baseline in the Quality of Life Scale (QOLS) at the end of intervention (after 5th session)
Time Frame
Baseline, end of intervention (appr. 2 months)
Title
Change from Baseline in the Quality of Life Scale (QOLS) at follow-up
Time Frame
Baseline, 3-month follow-up
Title
Change from Baseline in the European Quality of Life-5 dimensions scale (EQ-5D) at the end of intervention (after 5th session)
Time Frame
Baseline, end of intervention (appr. 2 months)
Title
Change from Baseline in the European Quality of Life-5 dimensions scale (EQ-5D) at follow-up
Time Frame
Baseline, 3-month follow-up
Other Pre-specified Outcome Measures:
Title
Change from Baseline in the Self-efficacy-scale (general subscale: GSE) at the end of intervention (after 5th session)
Time Frame
Baseline, end of intervention (appr. 2 months)
Title
Change from Baseline in the Self-efficacy-scale (general subscale: GSE) at follow-up
Time Frame
Baseline, 3-month follow-up
Title
Change from Baseline in the Self-efficacy-scale (social subscale: SSE) at the end of intervention (after 5th session)
Time Frame
Baseline, end of intervention (appr. 2 months)
Title
Change from Baseline in the Self-efficacy-scale (social subscale: SSE) at follow-up
Time Frame
Baseline, 3-month follow-up
Title
Change from Baseline in the Thought control questionnaire (TCQ) at the end of intervention (after 5th session)
Time Frame
Baseline, end of intervention (appr. 2 months)
Title
Change from Baseline in the Thought control questionnaire (TCQ) at follow-up
Time Frame
Baseline, 3-month follow-up
Title
Change from Baseline in the Thought control ability questionnaire (TCAQ) at the end of intervention (after 5th session)
Time Frame
Baseline, end of intervention (appr. 2 months)
Title
Change from Baseline in the Thought control ability questionnaire (TCAQ) at follow-up
Time Frame
Baseline, 3-month follow-up
Title
Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BAS scale, at the end of intervention (after 5th session)
Time Frame
Baseline, end of intervention (appr. 2 months)
Title
Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BAS scale, at follow-up
Time Frame
Baseline, 3-month follow-up
Title
Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BIS scale, at the end of intervention (after 5th session)
Time Frame
Baseline, end of intervention (appr. 2 months)
Title
Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BIS scale, at follow-up
Time Frame
Baseline, 3-months follow-up
Title
Change from Baseline in health service resource use as measured with a Resource Use Questionnaire
Time Frame
Baseline, 3-months follow-up
Title
Change from before to after scan in the Profile of Mood States (POMS)
Description
Measure to address any imminent changes in mood state.
Time Frame
Before and after each scanning session (appr. 2 months: session 1: week 1; session 2: week 2; session 3: week 3; session 4: week 4; session 5: week 8)
Title
Relation between upregulation ability of target areas (as obtained by functional MRI analysis) and perceived self control
Description
Analysis of the relationship between scores on the self-efficacy scales, thought control questionnaire (TCQ), thought control ability questionnaire (TCAQ) and the behavioural inhibition system and behavioural activation system (BIS/BAS) scales and fMRI data.
Time Frame
Integrating imaging and psychometric data across the intervention period (appr. 2 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
major depressive disorder (MDD) diagnosis
stable antidepressant dose medication
Exclusion Criteria:
Other physical or psychiatric disorders
Current substance abuse
Current psychotherapy or other specific intervention
Exclusion criteria applicable to MRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David E Linden, MD
Organizational Affiliation
Cardiff University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CUBRIC
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF103AT
Country
United Kingdom
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
19646532
Citation
Johnston SJ, Boehm SG, Healy D, Goebel R, Linden DE. Neurofeedback: A promising tool for the self-regulation of emotion networks. Neuroimage. 2010 Jan 1;49(1):1066-72. doi: 10.1016/j.neuroimage.2009.07.056. Epub 2009 Jul 29.
Results Reference
background
PubMed Identifier
21264651
Citation
Johnston S, Linden DE, Healy D, Goebel R, Habes I, Boehm SG. Upregulation of emotion areas through neurofeedback with a focus on positive mood. Cogn Affect Behav Neurosci. 2011 Mar;11(1):44-51. doi: 10.3758/s13415-010-0010-1.
Results Reference
background
PubMed Identifier
26088117
Citation
Fovet T, Jardri R, Linden D. Current Issues in the Use of fMRI-Based Neurofeedback to Relieve Psychiatric Symptoms. Curr Pharm Des. 2015;21(23):3384-94. doi: 10.2174/1381612821666150619092540.
Results Reference
derived
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Neurofeedback as a Treatment Tool for Depression
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