Neurofeedback as a Treatment Tool for Depression (NFD)

December 13, 2016 updated by: David Linden, Cardiff University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4XN
        • School of Medicine, Cardiff University
      • Cardiff, Wales, United Kingdom, CF103AT
        • CUBRIC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
Before start trial (baseline), after intervention (appr. 2 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at follow-up
Time Frame: Baseline, 3-month 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)
Time Frame: Baseline, end of intervention (appr. 2 months)
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
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)
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
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)
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
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)
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
Baseline, 3-month follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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
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.
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)
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.
Integrating imaging and psychometric data across the intervention period (appr. 2 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cardiff University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical Research Council
National Institute for Social Care and Health Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David E Linden, MD, Cardiff University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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