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

ConditionMajor Depressive Disorder (MDD)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversity of Oxford

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Active BiofeedbackExperimental treatment 1 intervention

Group B: Sham BiofeedbackSham comparator 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

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.

Time frame

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

Secondary outcomes

VTA Activation

Blood-oxygen-level-dependent (BOLD) signal in the bilateral ventral tegmental area (VTA) region of interest for MOTIVATE versus active rest trials, measured with task-based 7-Tesla fMRI. Unit of measure: percent BOLD signal change.

Time frame

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

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

The standardized VTA activation and connectivity measure will each be tested for an association with change in the mood and motivation factor. One coefficient is reported per VTA measure. Unit of measure: standardized regression coefficient (dimensionless, from -1 to 1).

Time frame

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

Other outcomes

Mood and Motivation EMA

Single-item mood and motivation ecological momentary assessment (EMA). Unit of measure: arbirary likert rating.

Time frame

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

Sponsors and contacts

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

University of Oxford

Lead sponsor

Wellcome Trust

Collaborator

Source ClinicalTrials.gov

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