NCT03609749

Mindful Self-Regulation fMRI Study (MindfulPCfMRI)

Mindfulness Influences on Self-Regulation: Mindful Self-Regulation fMRI Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Cambridge Health Alliance · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate changes in functional neural activation during self-regulation tasks before compared to after the Mindfulness Training for Primary Care intervention (see MINDFUL-PC (Phase 3) clinical trial). The study will also look at whether chronic disease self-management action plan initiation and successful engagement of self-report and behavioral self-regulation targets relates to the observed brain activation changes after compared to before the mindfulness intervention.

Detailed description

The investigators will investigate the effects of MTPC on pre/post changes in neural function with self-regulation target engagement, using self-appraisal, cuff pain and pain anticipation, and interoceptive attention fMRI tasks among primary care patients with an anxiety or depressive disorder. Primary outcome for this study is evaluating the changes in OFC activation during self-criticism blocks within a self-appraisal fMRI task. Secondary outcomes include changes in activation during self-appraisal fMRI task, pain regulation task, and interoceptive attention task, and the relationship of these targets with medical regimen adherence.

Conditions

• Anxiety
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness Training for Primary Care	For intervention description see Mindfulness Training for Primary Care (MTPC) in the study "MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 3)"

Timeline

• Start date: 2019-01-30
• Primary completion: 2020-04-01
• Completion: 2020-08-01
• First posted: 2018-08-01
• Last updated: 2020-11-13

Locations

1 site across 1 country: United States