Repeated Real-time Biofeedback With 7-Tesla MRI for Treatment of Depression

NCT07694076 | Recruiting

• 2 other identifiers: MS IDREC 879781226532/Z/22/Z
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Previous work demonstrated that individuals are able to self-regulate their ventral tegmental area (VTA) activity using real-time biofeedback. The current study expands this approach to a larger sample with repeated training sessions to more robustly characterize the effects of VTA modulation. The study will assess change in mood and motivation-related measures, as well as neural activity and connectivity changes.

Conditions

Major Depressive Disorder (MDD)

Keywords

Brain imaging; Biofeedback; 7-Tesla MRI; Depression; Dopamine

Outcome Measures

Primary Outcomes (2)

• Mood and Motivation Related Measures

  A single composite metric will be derived by factor analysis of a battery of validated mood and motivation related instruments (e.g. PANAS-SF, POMS-SF, PHQ-9, MAP-SR), providing one expected latent mood and motivation factor. Modelling the instruments jointly avoids nominating any single scale as the outcome, and controls for multiple comparisons. Unit of measure: standardized latent factor score (z / SD units).

  Pre to post biofeedback training, within a 6-week timeframe.

• VTA Connectivity

  Functional connectivity between the VTA seed and whole-brain (voxelwise), measured with 7-Tesla fMRI. Unit of measure: Fisher z-transformed correlation coefficient.

  Pre to post biofeedback training, within a 4-week timeframe.

Secondary Outcomes (2)

• VTA Activation

  Pre to post biofeedback training, within a 4-week timeframe.

• Association between change in VTA measures and change in the mood and motivation factor

  Pre to post biofeedback training, within a 6-week timeframe.

Other Outcomes (1)

• Mood and Motivation EMA

  Pre to post biofeedback training, within a 6-week timeframe.

Study Arms (2)

Active Biofeedback

EXPERIMENTAL

The participants in the active group will receive repeated active biofeedback training sessions.

Behavioral: Active Biofeedback

Sham Biofeedback

SHAM COMPARATOR

The participants in the sham group will receive repeated sham biofeedback training sessions.

Behavioral: Sham Biofeedback

Interventions

Active Biofeedback BEHAVIORAL

The active biofeedback session will be done within the 7T MRI. It will include MOTIVATE and active rest trials. During each MOTIVATE trial, subjects will be instructed to generate a heightened state of motivation. Subjects will simultaneously view a progress bar on the screen during MOTIVATE trials that represents their VTA activity and they will be trained to try to increase the level of the bar by motivating themselves.

Active Biofeedback

Sham Biofeedback BEHAVIORAL

The sham biofeedback session resembles the active condition, however, the progress bar seen during the MOTIVATE trials will represent yoked sham values.

Sham Biofeedback

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18-65 years;
• Meets DSM-5 criteria for major depressive disorder (MDD) as determined by the Structured Clinical Interview for DSM-5 Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI); with a current major depressive episode.
• Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process.

You may not qualify if:

• Current or history of schizophrenia or other psychotic disorder, neurodevelopmental disorder, neurocognitive disorder or cognitive impairment
• Active substance use disorder within the past 1 year;
• Any unstable medical illnesses;
• Women who are pregnant;
• Any contraindications to MRI
• Antidepressant medication initiated within 2 weeks of the Baseline Assessment and concomitant use of any other medication with central nervous system activity during active participation;
• Active suicidal intent or plan.

Sponsors & Collaborators

• University of Oxford: lead
• Wellcome Trust: collaborator

Study Sites (1)

Oxford Centre for Integrative Neuroimaging (OxCIN) FMRIB, Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital

Oxford, OX39DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Laurel S Morris, Dr

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurel S Morris, Dr

CONTACT

01865 (6)16577; laurel.morris@ndcn.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: July 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2033
• Last Updated: July 9, 2026

Record last verified: 2026-06

Locations

GB (1)