Mechanisms of Repeated Real-time Biofeedback With 7-Tesla MRI in Depression
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. This mechanistic study will assess change in mood and motivation-related measures, as well as neural activity and connectivity changes.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Major depressive disorder (MDD) is one of the world's largest health problems with current treatments that are ineffective for a substantial proportion of individuals. There is a critical need for mechanistically informed interventions that are individualized and that aim to target core symptoms. Converging evidence from animal and human research in the field has implicated the ventral tegmental area (VTA), a key component of the brain's dopamine system, in regulating motivation and reward-related behaviour. Previous work has demonstrated that participants can successfully train to self-regulate their VTA activity using cognitive strategies while receiving real-time feedback. This shows that VTA self-regulation is feasible in humans. The current study builds on this previous work to further investigate the relationships between VTA activity modulation and mood and motivation related changes in individuals with MDD, in a mechanistic manner. Specifically, this study will aim to extend on prior findings by increasing the sample size and incorporating repeated training sessions. A total of 60 participants with MDD will be recruited and will be randomized in a 1:1 ratio to receive either active biofeedback or sham (control) feedback. Participants will complete two training sessions with real-time 7T-MRI biofeedback. During functional MRI (fMRI) scanning, participants will be trained to use self-generated cognitive strategies to modulate their VTA activity while viewing a visual representation of their brain signal (active condition) or a yoked control signal (sham condition). The primary objective of this study is to determine how variation in VTA modulation is associated with mood and motivation related mechanisms that might change over time. Secondary objectives include assessing changes in VTA activation and functional connectivity over time, as well as examining how neural changes relate to mood and motivation-related changes.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Laurel S Morris, Dr
- Numéro de téléphone: 01865 (6)16577
- E-mail: laurel.morris@ndcn.ox.ac.uk
Lieux d'étude
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Oxford, Royaume-Uni, OX39DU
- Recrutement
- Oxford Centre for Integrative Neuroimaging (OxCIN) FMRIB, Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 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; as conducted in a research-based non-clinical setting.
- 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.
Exclusion Criteria:
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Active Biofeedback
The participants in the active group will receive repeated active biofeedback training sessions. |
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. |
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Comparateur factice: Sham Biofeedback
The participants in the sham group will receive repeated sham biofeedback training sessions. |
The sham biofeedback session resembles the active condition, however, the progress bar seen during the MOTIVATE trials will represent yoked sham values. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mood and Motivation Related Mechanistic Measures
Délai: Pre to post biofeedback training, within a 6-week timeframe.
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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, MAP-SR), providing one expected latent mood and motivation factor. Modelling the instruments jointly avoids nominating any single scale as the mechanistic 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.
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VTA Connectivity
Délai: Pre to post biofeedback training, within a 4-week timeframe.
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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.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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VTA Activation
Délai: Pre to post biofeedback training, within a 4-week timeframe.
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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. |
Pre to post biofeedback training, within a 4-week timeframe.
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Association between change in VTA measures and change in the mood and motivation factor
Délai: Pre to post biofeedback training, within a 6-week timeframe.
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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). |
Pre to post biofeedback training, within a 6-week timeframe.
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
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Mood and Motivation EMA
Délai: Pre to post biofeedback training, within a 6-week timeframe.
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Single-item mood and motivation ecological momentary assessment (EMA). Unit of measure: arbitrary likert rating. |
Pre to post biofeedback training, within a 6-week timeframe.
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Laurel S Morris, Dr, University of Oxford
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MS IDREC 879781
- 226532/Z/22/Z (Autre subvention/numéro de financement: Wellcome Trust)
Plan pour les données individuelles des participants (IPD)
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