Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-02-28 @ 5:31 AM
Study NCT ID:
NCT03609450
Status:
TERMINATED
Last Update Posted:
2020-11-20
First Post:
2018-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 3)
Sponsor:
Cambridge Health Alliance
Organization:
Study Overview
Official Title:
Mindfulness Influences on Self-regulation: Mental and Physical Health Implications -- Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 3)
Status:
TERMINATED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID-19 Pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MINDFUL-PC-3
Brief Summary:
This study compares the effectiveness of an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care\[MTPC\]) vs. a low-dose mindfulness comparator on self-regulation targets, specifically the primary outcome of emotion regulation. Secondary outcomes include sustained attention/response inhibition and interoceptive awareness. A secondary analysis will investigate the extent to which these self-regulation targets mediate the impact of MTPC group on action plan initiation.
Detailed Description:
The current Phase 3 comparative effectiveness randomized controlled trial examines impact of MTPC on specific mechanisms of change such as emotion regulation (primary outcome), interoceptive awareness and sustained attention/response inhibition (secondary outcomes). This study will also investigate the extent to which these self-regulation targets mediate the impact of MTPC group on action plan initiation. Participants randomized to 8-week MTPC are compared with participants randomized to a low-dose mindfulness comparator condition, in which they receive a 1-hour introduction to mindfulness with a referral to community mindfulness resources. Outcome assessments are conducted at baseline and study weeks 8-10. This study builds on the Phase 2 study, which demonstrated that Mindfulness Training for Primary Care enhanced chronic illness self-management action plan initiation among primary care patients receiving care in an urban, community, multi-cultural safety net healthcare system.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UH3AT009145 | NIH | None | https://reporter.nih.gov/quic… | View |