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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

February 23, 2012
December 13, 2016
March 2012
September 2014   (Final data collection date for primary outcome measure)
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) ]
Change in Hamilton Depression Rating Scale (HDRS) score [ Time Frame: Before start trial, after 4 weeks (i.e. 4 sessions), after 2 months (i.e. 5 sessions) and at 5 months (follow-up) ]
Complete list of historical versions of study NCT01544205 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
  • 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.
Not Provided
 
Neurofeedback as a Treatment Tool for Depression
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Unipolar Depression
Other: fMRI-based neurofeedback
5 sessions lasting one hour each
  • 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).
    Intervention: Other: fMRI-based neurofeedback
  • 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).
    Intervention: Other: fMRI-based neurofeedback

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
September 2014
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01544205
SPON927-11, G 1100629, HS/10/25, 11/WA/0106
Not Provided
Not Provided
Not Provided
Not Provided
David Linden, Cardiff University
Cardiff University
  • Medical Research Council
  • National Institute for Social Care and Health Research
Principal Investigator: David E Linden, MD Cardiff University
Cardiff University
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP