Unipolar Depression
Conditions
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.
Interventions
5 sessions lasting one hour each
Sponsors
Medical Research Council
National Institute for Social Care and Health Research
Cardiff University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 *
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| 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 Hamilton Depression Rating Scale (HDRS) score at follow-up | Baseline, 3-month follow-up |
| 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 Quality of Life Scale (QOLS) at the end of intervention (after 5th session) | Baseline, end of intervention (appr. 2 months) |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 the Self-efficacy-scale (general subscale: GSE) at the end of intervention (after 5th session) | Baseline, end of intervention (appr. 2 months) | — |
| Change from before to after scan in the Profile of Mood States (POMS) | 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 to address any imminent changes in mood state. |
| Relation between upregulation ability of target areas (as obtained by functional MRI analysis) and perceived self control | Integrating imaging and psychometric data across the intervention period (appr. 2 months) | 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. |
| Change from Baseline in health service resource use as measured with a Resource Use Questionnaire | Baseline, 3-months follow-up | — |
| Change from Baseline in the Self-efficacy-scale (general subscale: GSE) 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 | — |
Countries
United Kingdom
Outcome results
None listed