Clinical trial NCT01544205: Neurofeedback as a Treatment Tool for Depression
Official title: fMRI Based Neurofeedback as a Treatment Method for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unipolar Depression
Lead sponsor: Cardiff University
Sponsor class: OTHER
Collaborators: name: Medical Research Council
name: National Institute for Social Care and Health Research
First posted: 2012-03-05
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at the end of intervention (after 5th session)
timeFrame: Before start trial (baseline), after intervention (appr. 2 months)
Secondary outcomes:
measure: Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at follow-up
timeFrame: Baseline, 3-month follow-up
measure: Change from Baseline in Hospital Anxiety and Depression Scale (HADS) anxiety score at the end of intervention (after 5th session)
timeFrame: Baseline, end of intervention (appr. 2 months)
measure: Change from Baseline in Hospital Anxiety and Depression Scale (HADS) anxiety score at follow-up
timeFrame: Baseline, 3-month follow-up
measure: Change from Baseline in Hospital Anxiety and Depression Scale (HADS) depression score at the end of intervention (after 5th session)
timeFrame: Baseline, end of intervention (appr. 2 months)
measure: Change from Baseline in Hospital Anxiety and Depression Scale (HADS) depression score at follow-up
timeFrame: Baseline, 3-month follow-up
measure: Change from Baseline in the Quality of Life Scale (QOLS) at the end of intervention (after 5th session)
timeFrame: Baseline, end of intervention (appr. 2 months)
measure: Change from Baseline in the Quality of Life Scale (QOLS) at follow-up
timeFrame: Baseline, 3-month follow-up
measure: Change from Baseline in the European Quality of Life-5 dimensions scale (EQ-5D) at the end of intervention (after 5th session)
timeFrame: Baseline, end of intervention (appr. 2 months)
measure: Change from Baseline in the European Quality of Life-5 dimensions scale (EQ-5D) at follow-up
timeFrame: Baseline, 3-month follow-up
Other outcomes:
measure: Change from Baseline in the Self-efficacy-scale (general subscale: GSE) at the end of intervention (after 5th session)
timeFrame: Baseline, end of intervention (appr. 2 months)
measure: Change from Baseline in the Self-efficacy-scale (general subscale: GSE) at follow-up
timeFrame: Baseline, 3-month follow-up
measure: Change from Baseline in the Self-efficacy-scale (social subscale: SSE) at the end of intervention (after 5th session)
timeFrame: Baseline, end of intervention (appr. 2 months)
measure: Change from Baseline in the Self-efficacy-scale (social subscale: SSE) at follow-up
timeFrame: Baseline, 3-month follow-up
measure: Change from Baseline in the Thought control questionnaire (TCQ) at the end of intervention (after 5th session)
timeFrame: Baseline, end of intervention (appr. 2 months)
measure: Change from Baseline in the Thought control questionnaire (TCQ) at follow-up
timeFrame: Baseline, 3-month follow-up
measure: Change from Baseline in the Thought control ability questionnaire (TCAQ) at the end of intervention (after 5th session)
timeFrame: Baseline, end of intervention (appr. 2 months)
measure: Change from Baseline in the Thought control ability questionnaire (TCAQ) at follow-up
timeFrame: Baseline, 3-month follow-up
measure: Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BAS scale, at the end of intervention (after 5th session)
timeFrame: Baseline, end of intervention (appr. 2 months)
measure: Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BAS scale, at follow-up
timeFrame: Baseline, 3-month follow-up
measure: Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BIS scale, at the end of intervention (after 5th session)
timeFrame: Baseline, end of intervention (appr. 2 months)
measure: Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BIS scale, at follow-up
timeFrame: Baseline, 3-months follow-up
measure: Change from Baseline in health service resource use as measured with a Resource Use Questionnaire
timeFrame: Baseline, 3-months follow-up
measure: Change from before to after scan in the Profile of Mood States (POMS)
timeFrame: 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)
measure: Relation between upregulation ability of target areas (as obtained by functional MRI analysis) and perceived self control
timeFrame: Integrating imaging and psychometric data across the intervention period (appr. 2 months)
Locations:
city: Cardiff
country: United Kingdom
facility: CUBRIC
state: Wales
city: Cardiff
country: United Kingdom
facility: School of Medicine, Cardiff University
state: Wales
Study officials:
affiliation: Cardiff University
name: David E Linden, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.