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Completed

NCT Number: NCT01544205

Neurofeedback as a Treatment Tool 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.

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Key information

Conditions

Unipolar Depression Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CUBRIC, Cardiff, Wales, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fMRI-based neurofeedback

Other

5 sessions lasting one hour each

Primary outcomes

  1. 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 outcomes

  1. Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at follow-up

    Time frame: 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)

    Time frame: Baseline, end of intervention (appr. 2 months)

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

    Time frame: 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)

    Time frame: Baseline, end of intervention (appr. 2 months)

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

    Time frame: Baseline, 3-month follow-up

  6. 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)

  7. Change from Baseline in the Quality of Life Scale (QOLS) at follow-up

    Time frame: 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)

    Time frame: 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

    Time frame: Baseline, 3-month follow-up

Other outcomes

  1. 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)

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

    Time frame: 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)

    Time frame: Baseline, end of intervention (appr. 2 months)

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

    Time frame: Baseline, 3-month follow-up

  5. 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)

  6. Change from Baseline in the Thought control questionnaire (TCQ) at follow-up

    Time frame: Baseline, 3-month follow-up

  7. 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)

  8. Change from Baseline in the Thought control ability questionnaire (TCAQ) at follow-up

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: Baseline, 3-months follow-up

  13. Change from Baseline in health service resource use as measured with a Resource Use Questionnaire

    Time frame: Baseline, 3-months follow-up

  14. 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.

  15. 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.

Sponsors and collaborators

Lead sponsor

Cardiff University

Other

Collaborators

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

Registry information

Official study title

fMRI Based Neurofeedback as a Treatment Method for Depression

Acronym: NFD

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 5, 2012
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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