NCT06675240

Brief Summary

The goal of this open-label single-arm study is to test a meditative neurofeedback intervention for depressed mood.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress57%
Nov 2024Jun 2027

First Submitted

Initial submission to the registry

November 3, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2027

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

November 3, 2024

Last Update Submit

January 12, 2026

Conditions

Depression - Major Depressive DisorderDepression Disorders

Keywords

meditationneurofeedbackruminationEEGanxietydepression

Outcome Measures

Primary Outcomes (1)

  • PHQ9

    Depression Symptoms on the Patient Health Questionnaire 9-item (PHQ9) scale, min 0 max 27 with lower scores representing better outcome

    8 weeks

Secondary Outcomes (3)

  • MAAS

    8 weeks

  • RRQ

    8 weeks

  • GAD7

    8 weeks

Study Arms (1)

MediNF

EXPERIMENTAL

Over 10-sessions participants will engage in a breath-focused meditative practice with frontal brain connectivity neurofeedback provided to enhance performance.

Behavioral: MediNF

Interventions

MediNFBEHAVIORAL

Over 10-sessions participants will engage in a breath-focused meditative practice with frontal brain connectivity neurofeedback provided to enhance performance.

MediNF

Eligibility Criteria

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

You may qualify if:

  • moderate depression per PHQ9 symptom ratings

You may not qualify if:

  • active substance abuse/dependence
  • psychotic disorders
  • bipolar disorder
  • displaying acutely suicidal behaviors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Rumination SyndromeAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesFeeding and Eating DisordersMental DisordersBehavioral SymptomsBehavior

Central Study Contacts

Jyoti Mishra, PhD

CONTACT

619-940-4230braine@ucsd.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 3, 2024

First Posted

November 5, 2024

Study Start

November 15, 2024

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

June 15, 2027

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)