Neurofeedback as a Treatment Tool for Depression (NFD)

fMRI Based Neurofeedback as a Treatment Method for Depression

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.

Study Overview

• Status: Completed
• Conditions: Unipolar Depression
• Intervention / Treatment: Other: fMRI-based neurofeedback

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Wales
    • Cardiff, Wales, United Kingdom, CF14 4XN
      • School of Medicine, Cardiff University
    • Cardiff, Wales, United Kingdom, CF103AT
      • CUBRIC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emotion network up-regulation; 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; 5 sessions lasting one hour each
Active Comparator: Place processing network up-regulation; 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; 5 sessions lasting one hour each

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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
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)

Collaborators and Investigators

• Sponsor: Cardiff University
• Collaborators: Medical Research Council; National Institute for Social Care and Health Research
• Investigators: Principal Investigator: David E Linden, MD, Cardiff University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: February 23, 2012
• First Submitted That Met QC Criteria: February 28, 2012
• First Posted (Estimate): March 5, 2012

Study Record Updates

• Last Update Posted (Estimate): December 15, 2016
• Last Update Submitted That Met QC Criteria: December 13, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: SPON927-11; G 1100629 (Other Grant/Funding Number: MRC); HS/10/25 (Other Grant/Funding Number: NISCHR); 11/WA/0106 (Other Identifier: NHS Research Ethics Committee)