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Neurofeedback as a Treatment Tool for Depression (NFD)

This study has been completed.
Sponsor:
Collaborators:
Medical Research Council
National Institute for Social Care and Health Research
Information provided by (Responsible Party):
David Linden, Cardiff University
ClinicalTrials.gov Identifier:
NCT01544205
First received: February 23, 2012
Last updated: December 13, 2016
Last verified: December 2016
  Purpose
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 Intervention
Unipolar Depression Other: fMRI-based neurofeedback

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: fMRI Based Neurofeedback as a Treatment Method for Depression

Further study details as provided by David Linden, Cardiff University:

Primary Outcome Measures:
  • Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at the end of intervention (after 5th session) [ Time Frame: Before start trial (baseline), after intervention (appr. 2 months) ]

Secondary Outcome Measures:
  • Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at follow-up [ Time Frame: 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) [ Time Frame: Baseline, end of intervention (appr. 2 months) ]
  • Change from Baseline in Hospital Anxiety and Depression Scale (HADS) anxiety score at follow-up [ Time Frame: 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) [ Time Frame: Baseline, end of intervention (appr. 2 months) ]
  • Change from Baseline in Hospital Anxiety and Depression Scale (HADS) depression score at follow-up [ Time Frame: Baseline, 3-month follow-up ]
  • Change from Baseline in the Quality of Life Scale (QOLS) at the end of intervention (after 5th session) [ Time Frame: Baseline, end of intervention (appr. 2 months) ]
  • Change from Baseline in the Quality of Life Scale (QOLS) at follow-up [ Time Frame: 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) [ Time Frame: Baseline, end of intervention (appr. 2 months) ]
  • Change from Baseline in the European Quality of Life-5 dimensions scale (EQ-5D) at follow-up [ Time Frame: Baseline, 3-month follow-up ]

Other Outcome Measures:
  • Change from Baseline in the Self-efficacy-scale (general subscale: GSE) at the end of intervention (after 5th session) [ Time Frame: Baseline, end of intervention (appr. 2 months) ]
  • Change from Baseline in the Self-efficacy-scale (general subscale: GSE) at follow-up [ Time Frame: Baseline, 3-month follow-up ]
  • Change from Baseline in the Self-efficacy-scale (social subscale: SSE) at the end of intervention (after 5th session) [ Time Frame: Baseline, end of intervention (appr. 2 months) ]
  • Change from Baseline in the Self-efficacy-scale (social subscale: SSE) at follow-up [ Time Frame: Baseline, 3-month follow-up ]
  • Change from Baseline in the Thought control questionnaire (TCQ) at the end of intervention (after 5th session) [ Time Frame: Baseline, end of intervention (appr. 2 months) ]
  • Change from Baseline in the Thought control questionnaire (TCQ) at follow-up [ Time Frame: Baseline, 3-month follow-up ]
  • Change from Baseline in the Thought control ability questionnaire (TCAQ) at the end of intervention (after 5th session) [ Time Frame: Baseline, end of intervention (appr. 2 months) ]
  • Change from Baseline in the Thought control ability questionnaire (TCAQ) at follow-up [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Baseline, 3-months follow-up ]
  • Change from Baseline in health service resource use as measured with a Resource Use Questionnaire [ Time Frame: Baseline, 3-months follow-up ]
  • Change from before to after scan in the Profile of Mood States (POMS) [ Time Frame: 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.

  • Relation between upregulation ability of target areas (as obtained by functional MRI analysis) and perceived self control [ Time Frame: 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.


Enrollment: 43
Study Start Date: March 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544205

Locations
United Kingdom
CUBRIC
Cardiff, Wales, United Kingdom, CF103AT
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
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Linden, Professor of Translational Neuroscience, Cardiff University
ClinicalTrials.gov Identifier: NCT01544205     History of Changes
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 )
Study First Received: February 23, 2012
Last Updated: December 13, 2016

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 23, 2017