Unipolar DepressionNFDNCT01544205
Neurofeedback as a Treatment Tool for Depression
A study testing fMRI-based neurofeedback in people with Unipolar Depression, run by Cardiff University at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unipolar Depression
- What is being tested?
- fMRI-based neurofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Mar 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- major depressive disorder (MDD) diagnosis
- stable antidepressant dose medication
Who cannot join
- Other physical or psychiatric disorders
- Current substance abuse
- Current psychotherapy or other specific intervention
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
CUBRIC
Cardiff, Wales, CF103AT
School of Medicine, Cardiff University
Cardiff, Wales, CF14 4XN
About this study
Official title: 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.
- Conditions
- Unipolar Depression
- Being tested
- fMRI-based neurofeedback
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI-based neurofeedbackOther
5 sessions lasting one hour each
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: fMRI-based neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at the end of intervention (after 5th session)
Measured: 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
Measured: 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)
Measured: Baseline, end of intervention (appr. 2 months)
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) anxiety score at follow-up
Measured: 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)
Measured: Baseline, end of intervention (appr. 2 months)
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) depression score at follow-up
Measured: Baseline, 3-month follow-up
Change from Baseline in the Quality of Life Scale (QOLS) at the end of intervention (after 5th session)
Measured: Baseline, end of intervention (appr. 2 months)
Change from Baseline in the Quality of Life Scale (QOLS) at follow-up
Measured: 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)
Measured: Baseline, end of intervention (appr. 2 months)
Change from Baseline in the European Quality of Life-5 dimensions scale (EQ-5D) at follow-up
Measured: Baseline, 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, National Institute for Social Care and Health Research
- Responsible party
- Principal investigator, David Linden, Cardiff University
- Investigators
- David E Linden, MD, Principal investigator, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544205
- Sponsor's protocol ID
- SPON927-11
- Other IDs
- G 1100629, HS/10/25, 11/WA/0106
- Acronym
- NFD
- Status last verified
- Sep 2024
- First submitted
- 23 Feb 2012
- Last updated
- 19 Sep 2024
- Results posted
- No
Publications
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.
PubMed 19646532Johnston 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.
PubMed 21264651Fovet 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.
PubMed 26088117
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fMRI Based Neurofeedback as a Treatment Method for Depression
- ClinicalTrials.gov ID
- NCT01544205
- Acronym / sponsor ID
- NFD / SPON927-11
- Conditions
- Unipolar Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Cardiff UniversityUniversity, hospital or other
- Collaborators
- Medical Research Council, National Institute for Social Care and Health Research
- Study start
- Mar 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotion network up-regulation | Experimental | Other: fMRI-based neurofeedbackParticipants use fMRI-based neurofeedback to train the upregulation of brain areas that respond to positive affective pictures (as identified during a functional localiser scan). |
| Place processing network up-regulation | Active comparator | Other: fMRI-based neurofeedbackParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- major depressive disorder (MDD) diagnosis
- stable antidepressant dose medication
Key exclusion criteria (3 listed)
- Other physical or psychiatric disorders
- Current substance abuse
- Current psychotherapy or other specific intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRI-based neurofeedback5 sessions lasting one hour each | Other | Emotion network up-regulation, Place processing network up-regulation |
Primary outcome
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)
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 19646532Johnston 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.
- Background: PubMed 21264651Johnston 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.
- Derived from this study: PubMed 26088117Fovet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David E Linden, MD principal investigator
Cardiff University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI-based neurofeedback in people with Unipolar Depression, run by Cardiff University at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01544205, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.