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| ID | Type | Description | Link |
|---|---|---|---|
| G 1100629 | Other Grant/Funding Number | MRC | |
| HS/10/25 | Other Grant/Funding Number | NISCHR | |
| 11/WA/0106 | Other Identifier | NHS Research Ethics Committee |
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| Name | Class |
|---|---|
| Medical Research Council | OTHER_GOV |
| National Institute for Social Care and Health Research | UNKNOWN |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emotion network up-regulation | Experimental | 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). |
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| Place processing network up-regulation | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fMRI-based neurofeedback | Other | 5 sessions lasting one hour each |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at the end of intervention (after 5th session) | Before start trial (baseline), after intervention (appr. 2 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at follow-up | Baseline, 3-month follow-up | |
| Change from Baseline in Hospital Anxiety and Depression Scale (HADS) anxiety score at the end of intervention (after 5th session) | Baseline, end of intervention (appr. 2 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Self-efficacy-scale (general subscale: GSE) at the end of intervention (after 5th session) | Baseline, end of intervention (appr. 2 months) | |
| Change from Baseline in the Self-efficacy-scale (general subscale: GSE) at follow-up | Baseline, 3-month follow-up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David E Linden, MD | Cardiff University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CUBRIC | Cardiff | Wales | CF103AT | United Kingdom | ||
| School of Medicine, Cardiff University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19646532 | Background | 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. | |
| 21264651 | Background | 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. |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Change from Baseline in Hospital Anxiety and Depression Scale (HADS) anxiety score at follow-up | Baseline, 3-month follow-up |
| Change from Baseline in Hospital Anxiety and Depression Scale (HADS) depression score at the end of intervention (after 5th session) | Baseline, end of intervention (appr. 2 months) |
| Change from Baseline in Hospital Anxiety and Depression Scale (HADS) depression score at follow-up | Baseline, 3-month follow-up |
| Change from Baseline in the Quality of Life Scale (QOLS) at the end of intervention (after 5th session) | Baseline, end of intervention (appr. 2 months) |
| Change from Baseline in the Quality of Life Scale (QOLS) at follow-up | Baseline, 3-month follow-up |
| Change from Baseline in the European Quality of Life-5 dimensions scale (EQ-5D) at the end of intervention (after 5th session) | Baseline, end of intervention (appr. 2 months) |
| Change from Baseline in the European Quality of Life-5 dimensions scale (EQ-5D) at follow-up | Baseline, 3-month follow-up |
| Change from Baseline in the Self-efficacy-scale (social subscale: SSE) at the end of intervention (after 5th session) | Baseline, end of intervention (appr. 2 months) |
| Change from Baseline in the Self-efficacy-scale (social subscale: SSE) at follow-up | Baseline, 3-month follow-up |
| Change from Baseline in the Thought control questionnaire (TCQ) at the end of intervention (after 5th session) | Baseline, end of intervention (appr. 2 months) |
| Change from Baseline in the Thought control questionnaire (TCQ) at follow-up | Baseline, 3-month follow-up |
| Change from Baseline in the Thought control ability questionnaire (TCAQ) at the end of intervention (after 5th session) | Baseline, end of intervention (appr. 2 months) |
| Change from Baseline in the Thought control ability questionnaire (TCAQ) at follow-up | Baseline, 3-month follow-up |
| Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BAS scale, at the end of intervention (after 5th session) | Baseline, end of intervention (appr. 2 months) |
| Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BAS scale, at follow-up | Baseline, 3-month follow-up |
| Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BIS scale, at the end of intervention (after 5th session) | Baseline, end of intervention (appr. 2 months) |
| Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BIS scale, at follow-up | Baseline, 3-months follow-up |
| Change from Baseline in health service resource use as measured with a Resource Use Questionnaire | Baseline, 3-months follow-up |
| Change from before to after scan in the Profile of Mood States (POMS) | Measure to address any imminent changes in mood state. | 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) |
| Relation between upregulation ability of target areas (as obtained by functional MRI analysis) and perceived self control | 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. | Integrating imaging and psychometric data across the intervention period (appr. 2 months) |
| Cardiff |
| Wales |
| CF14 4XN |
| United Kingdom |
| 26088117 | Derived | 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. |