NCT01544205

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.5 years

First QC Date

February 23, 2012

Last Update Submit

September 5, 2024

Conditions

Unipolar Depression

Outcome Measures

Primary Outcomes (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 Outcomes (9)

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

    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)

    Baseline, end of intervention (appr. 2 months)

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

    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)

    Baseline, end of intervention (appr. 2 months)

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

    Baseline, 3-month follow-up

  • +4 more secondary outcomes

Other Outcomes (15)

  • 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)

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

    Baseline, 3-month follow-up

  • 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)

  • +12 more other outcomes

Study Arms (2)

Emotion network up-regulation

EXPERIMENTAL

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

Place processing network up-regulation

ACTIVE COMPARATOR

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

Interventions

fMRI-based neurofeedbackOTHER

5 sessions lasting one hour each

Emotion network up-regulationPlace processing network up-regulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • major depressive disorder (MDD) diagnosis
  • stable antidepressant dose medication

You may not qualify if:

  • Other physical or psychiatric disorders
  • Current substance abuse
  • Current psychotherapy or other specific intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CUBRIC

Cardiff, Wales, CF103AT, United Kingdom

Location

School of Medicine, Cardiff University

Cardiff, Wales, CF14 4XN, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 19646532BACKGROUND

  • 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.

    PMID: 21264651BACKGROUND

  • Fovet T, Jardri R, Linden D. Current Issues in the Use of fMRI-Based Neurofeedback to Relieve Psychiatric Symptoms. Curr Pharm Des. 2015;21(23):3384-94. doi: 10.2174/1381612821666150619092540.

    PMID: 26088117DERIVED

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Study Officials

  • David E Linden, MD

    Cardiff University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Translational Neuroscience

Study Record Dates

First Submitted

February 23, 2012

First Posted

March 5, 2012

Study Start

March 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

GB(2)