Neurofeedback as a Treatment Tool for Depression

Unipolar Depression Clinical Trial

— NFD  

Official title:

fMRI Based Neurofeedback as a Treatment Method for Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544205
• Other study ID #: SPON927-11
• Secondary ID: G 1100629HS/10/2
• Status: Completed
• Phase: N/A
• First received: February 23, 2012
• Last updated: December 13, 2016
• Start date: March 2012
• Est. completion date: September 2014

Study information

• Verified date: December 2016
• Source: Cardiff University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Unipolar Depression

Intervention

Other:
• fMRI-based neurofeedback
5 sessions lasting one hour each

Locations

Country	Name	City	State
United Kingdom	CUBRIC	Cardiff	Wales
United Kingdom	School of Medicine, Cardiff University	Cardiff	Wales

Sponsors (3)

Lead Sponsor	Collaborator
Cardiff University	Medical Research Council, National Institute for Social Care and Health Research

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	No
Other	Change from Baseline in the Self-efficacy-scale (general subscale: GSE) at follow-up		Baseline, 3-month follow-up	No
Other	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)	No
Other	Change from Baseline in the Self-efficacy-scale (social subscale: SSE) at follow-up		Baseline, 3-month follow-up	No
Other	Change from Baseline in the Thought control questionnaire (TCQ) at the end of intervention (after 5th session)		Baseline, end of intervention (appr. 2 months)	No
Other	Change from Baseline in the Thought control questionnaire (TCQ) at follow-up		Baseline, 3-month follow-up	No
Other	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)	No
Other	Change from Baseline in the Thought control ability questionnaire (TCAQ) at follow-up		Baseline, 3-month follow-up	No
Other	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)	No
Other	Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BAS scale, at follow-up		Baseline, 3-month follow-up	No
Other	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)	No
Other	Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BIS scale, at follow-up		Baseline, 3-months follow-up	No
Other	Change from Baseline in health service resource use as measured with a Resource Use Questionnaire		Baseline, 3-months follow-up	No
Other	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)	No
Other	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)	No
Primary	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)	No
Secondary	Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at follow-up		Baseline, 3-month follow-up	No
Secondary	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)	No
Secondary	Change from Baseline in Hospital Anxiety and Depression Scale (HADS) anxiety score at follow-up		Baseline, 3-month follow-up	No
Secondary	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)	No
Secondary	Change from Baseline in Hospital Anxiety and Depression Scale (HADS) depression score at follow-up		Baseline, 3-month follow-up	No
Secondary	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)	No
Secondary	Change from Baseline in the Quality of Life Scale (QOLS) at follow-up		Baseline, 3-month follow-up	No
Secondary	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)	No
Secondary	Change from Baseline in the European Quality of Life-5 dimensions scale (EQ-5D) at follow-up		Baseline, 3-month follow-up	No