NFD: Neurofeedback as a Treatment Tool for Depression

• Sponsor: Cardiff University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01544205
• Collaborator: Medical Research Council (Other), National Institute for Social Care and Health Research (Other)
• Enrollment: 43
• Locations: 2
• Arms: 2
• Duration (Months): 30
• Patients Per Site: 21.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Unipolar Depression	Other: fMRI-based neurofeedback	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: fMRI Based Neurofeedback as a Treatment Method for Depression
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at follow-up [Baseline, 3-month follow-up]

2. 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)]

3. Change from Baseline in Hospital Anxiety and Depression Scale (HADS) anxiety score at follow-up [Baseline, 3-month follow-up]

4. 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)]

5. Change from Baseline in Hospital Anxiety and Depression Scale (HADS) depression score at follow-up [Baseline, 3-month follow-up]

6. 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)]

7. Change from Baseline in the Quality of Life Scale (QOLS) at follow-up [Baseline, 3-month follow-up]

8. 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)]

9. 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

1. 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)]

2. Change from Baseline in the Self-efficacy-scale (general subscale: GSE) at follow-up [Baseline, 3-month follow-up]

3. 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)]

4. Change from Baseline in the Self-efficacy-scale (social subscale: SSE) at follow-up [Baseline, 3-month follow-up]

5. Change from Baseline in the Thought control questionnaire (TCQ) at the end of intervention (after 5th session) [Baseline, end of intervention (appr. 2 months)]

6. Change from Baseline in the Thought control questionnaire (TCQ) at follow-up [Baseline, 3-month follow-up]

7. 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)]

8. Change from Baseline in the Thought control ability questionnaire (TCAQ) at follow-up [Baseline, 3-month follow-up]

9. 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)]

10. Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BAS scale, at follow-up [Baseline, 3-month follow-up]

11. 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)]

12. Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BIS scale, at follow-up [Baseline, 3-months follow-up]

13. Change from Baseline in health service resource use as measured with a Resource Use Questionnaire [Baseline, 3-months follow-up]

14. 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.

15. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

• Exclusion criteria applicable to MRI

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CUBRIC	Cardiff	Wales	United Kingdom	CF103AT
2	School of Medicine, Cardiff University	Cardiff	Wales	United Kingdom	CF14 4XN

Sponsors and Collaborators

• Cardiff University
• Medical Research Council
• National Institute for Social Care and Health Research

Investigators

• Principal Investigator: David E Linden, MD, Cardiff University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: David Linden, Professor of Translational Neuroscience, Cardiff University
• ClinicalTrials.gov Identifier: NCT01544205
• Other Study ID Numbers: SPON927-11; G 1100629; HS/10/25; 11/WA/0106
• First Posted: Mar 5, 2012
• Last Update Posted: Dec 15, 2016
• Last Verified: Dec 1, 2016

• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

No Results Posted as of Dec 15, 2016