Health TrialsbyHealthPanel

Meditative Neurofeedback for Depression

ConditionsDepression - Major Depressive DisorderDepression Disorders
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Diego

About this trial

The goal of this study is to test a meditative neurofeedback intervention for depressed mood.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

moderate depression per PHQ9 symptom ratings

Disqualifiers

active substance abuse/dependence

psychotic disorders

bipolar disorder

displaying acutely suicidal behaviors

Trial design

Design model

Parallel

Treatments tested in this trial

  • MediNF

    Behavioral

    Over 5-sessions participants will engage in a breath-focused meditative practice with frontal brain connectivity neurofeedback provided to enhance performance.

  • ShamMediNF

    Behavioral

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: MediNFExperimental treatment 1 intervention
Group B: ShamMediNFSham comparator 1 intervention
Group C: No ContactNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
8 weeks

Secondary outcomes

1

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.

Time frame
8 weeks
2

PHQ9

Self-rated depression symptoms on the Patient Health Questionnaire 9 item scale (PHJQ9), min 0 max 27 with lower scores representing better outcome.

Time frame
8 weeks
3

MADRS

Clinician rated depression symptoms on the Montgomery Åsberg Depression Rating Scale (MADRS), min 0 max 54 with lower scores representing better outcome.

Time frame
8 weeks
4

GAD7

Anxiety symptoms on the Generalized Anxiety Disorder 7-item (GAD7) scale, min 0 max 21 with lower scores representing better outcome.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Diego

Lead sponsor

Source ClinicalTrials.gov
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