Depression - Major Depressive DisorderPhase 1MediNFNCT06675240
Meditative Neurofeedback for Depression
A Phase 1 study testing MediNF in people with Depression - Major Depressive Disorder and Depression Disorders, run by University of California, San Diego at 1 site in United States.
Trial summary
The goal of this study is to test a meditative neurofeedback intervention for depressed mood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder, Depression Disorders
- What is being tested?
- MediNF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2024to 15 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- moderate depression per PHQ9 symptom ratings
Who cannot join
- active substance abuse/dependence
- psychotic disorders
- bipolar disorder
- displaying acutely suicidal behaviors
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Diego
La Jolla, California, 92093
Jyoti Mishra, 858-621-1517, braine@ucsd.edu
About this study
The goal of this study is to test a meditative neurofeedback intervention for depressed mood.
Read the detailed description
The goal of this study is to test whether a 5-session meditative neurofeedback intervention significantly alleviates depressive symptoms as well as improves secondary outcomes of rumination and mindfulness.
- Being tested
- MediNF, ShamMediNF
- Keywords
- meditation, neurofeedback, rumination, EEG, anxiety, depression
- Medical subject headings
- Rumination Syndrome, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MediNFBehavioural
Over 5-sessions participants will engage in a breath-focused meditative practice with frontal brain connectivity neurofeedback provided to enhance performance.
ShamMediNFBehavioural
Over 5-sessions participants will engage in a breath-focused meditative practice with frontal brain connectivity neurofeedback provided that is yoked to a closely-matched individual in the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| MediNF | Experimental | Over 5-sessions participants will engage in a breath-focused meditative practice with frontal brain connectivity neurofeedback provided to enhance performance. Receives: Behavioral: MediNF |
| ShamMediNF | Sham comparator | Over 5-sessions participants will engage in a breath-focused meditative practice with frontal brain connectivity neurofeedback provided that is yoked to a closely-matched individual in the experimental arm. Receives: Behavioral: ShamMediNF |
| No Contact | No intervention | No contact during the 4 week intervention period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FCz-FC4 alpha band coherence (iCoh)
EEG alpha band (8-12 Hz) imaginary coherence between FC4 and FCz electrodes is the primary outcome, higher scores represent better outcome, and the coherence measure is unitless.
Measured: 8 weeks
Secondary outcomes (6)
Change in EEG source localized right ACC - Insula alpha band connectivity
EEG source-localized right Anterior Cingulate Cortex (ACC) - Insula alpha band (8-12 Hz) connectivity during an attention to breathing task will serve as a secondary neural outcome, higher scores represent better outcome. The measure is based on regional neural activity correlations and is unitless.
Measured: 8 weeks
PHQ9
Self-rated depression symptoms on the Patient Health Questionnaire 9 item scale (PHJQ9), min 0 max 27 with lower scores representing better outcome.
Measured: 8 weeks
MADRS
Clinician rated depression symptoms on the Montgomery Åsberg Depression Rating Scale (MADRS), min 0 max 54 with lower scores representing better outcome.
Measured: 8 weeks
GAD7
Anxiety symptoms on the Generalized Anxiety Disorder 7-item (GAD7) scale, min 0 max 21 with lower scores representing better outcome.
Measured: 8 weeks
RRS
Rumination on the Ruminative Response Scale (RRS), min 22 max 88 with lower scores representing better outcome
Measured: 8 weeks
MAAS
Mindfulness on the Mindful Attention Awareness Scale (MAAS), min 6 max 84 with higher scores representing better outcome.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start15 Nov 2024
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jyoti Mishra, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675240
- Sponsor's protocol ID
- MediNF
- Acronym
- MediNF
- Status last verified
- Oct 2026
- First submitted
- 3 Nov 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditative Neurofeedback for Depression
- ClinicalTrials.gov ID
- NCT06675240
- Acronym / sponsor ID
- MediNF / MediNF
- Keywords
- meditation, neurofeedback, rumination, EEG, anxiety, depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 5 Nov 2024 (actual)
- 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 goal of this study is to test a meditative neurofeedback intervention for depressed mood.
Detailed description
The goal of this study is to test whether a 5-session meditative neurofeedback intervention significantly alleviates depressive symptoms as well as improves secondary outcomes of rumination and mindfulness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MediNF | Experimental | Behavioral: MediNFOver 5-sessions participants will engage in a breath-focused meditative practice with frontal brain connectivity neurofeedback provided to enhance performance. |
| ShamMediNF | Sham comparator | Behavioral: ShamMediNFOver 5-sessions participants will engage in a breath-focused meditative practice with frontal brain connectivity neurofeedback provided that is yoked to a closely-matched individual in the experimental arm. |
| No Contact | No intervention | –No contact during the 4 week intervention period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- moderate depression per PHQ9 symptom ratings
Key exclusion criteria (4 listed)
- active substance abuse/dependence
- psychotic disorders
- bipolar disorder
- displaying acutely suicidal behaviors
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 |
|---|---|---|
| MediNFOver 5-sessions participants will engage in a breath-focused meditative practice with frontal brain connectivity neurofeedback provided to enhance performance. | Behavioural | MediNF |
| ShamMediNFOver 5-sessions participants will engage in a breath-focused meditative practice with frontal brain connectivity neurofeedback provided that is yoked to a closely-matched individual in the experimental arm. | Behavioural | ShamMediNF |
Primary outcome
Change in FCz-FC4 alpha band coherence (iCoh)
Time frame: 8 weeks
EEG alpha band (8-12 Hz) imaginary coherence between FC4 and FCz electrodes is the primary outcome, higher scores represent better outcome, and the coherence measure is unitless.
6 secondary outcomes
Change in EEG source localized right ACC - Insula alpha band connectivity
Time frame: 8 weeks
PHQ9
Time frame: 8 weeks
MADRS
Time frame: 8 weeks
GAD7
Time frame: 8 weeks
RRS
Time frame: 8 weeks
MAAS
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MediNF in people with Depression - Major Depressive Disorder and Depression Disorders, run by University of California, San Diego at 1 site in United States.
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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jyoti Mishra, PhD (858-621-1517, braine@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FCz-FC4 alpha band coherence (iCoh) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.