Neurofeedback as a Treatment Tool for Depression

Not Applicable

Completed

• Conditions: Unipolar Depression
• Interventions: Other: fMRI-based neurofeedback

• Registration Number: NCT01544205
• Lead Sponsor: Cardiff University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-28
• Study Start: 2012-03
• Study First Posted: 2012-03-05
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-13
• Last Update Posted: 2016-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Emotion network up-regulation	fMRI-based neurofeedback	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).
Place processing network up-regulation	fMRI-based neurofeedback	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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 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 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 follow-up	Baseline, 3-month follow-up
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 European Quality of Life-5 dimensions scale (EQ-5D) at the end of intervention (after 5th session)	Baseline, end of intervention (appr. 2 months)

Trial Locations

Locations (2)

CUBRIC; 🇬🇧 Cardiff, Wales, United Kingdom

School of Medicine, Cardiff University; 🇬🇧 Cardiff, Wales, United Kingdom