Neurofeedback as a Treatment Tool for Depression

Study Overview
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Brief Summary
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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.

Official Title
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fMRI Based Neurofeedback as a Treatment Method for Depression

Conditions
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Unipolar Depression

Intervention / Treatment
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* Other: fMRI-based neurofeedback


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emotion network up-regulation<br>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). | Other: fMRI-based neurofeedback<br>* 5 sessions lasting one hour each<br>|
| Active Comparator: Place processing network up-regulation<br>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). | Other: fMRI-based neurofeedback<br>* 5 sessions lasting one hour each<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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 |