Diabetes distress is common affecting over one-third of people with type 2 diabetes, negatively impacting self-management and outcomes, and disproportionately affecting low-income individuals. The proposed project will conduct a pilot randomized controlled trial comparing Mindfulness-Based Diabetes Education to standard Diabetes Self-Management Education in adults with type 2 diabetes and elevated diabetes distress who receive care within safety-net healthcare systems in order to assess feasibility and acceptability.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Participant assessment of perceived positive and negative effects
Timeframe: 2 months
Participant assessment of intervention content
Timeframe: 2 months
Participant assessment of appropriateness of intervention duration and frequency
Timeframe: 2 months
Participant satisfaction with interventionist
Timeframe: 2 months
Participant-reported barriers to engagement with the intervention sessions or content
Timeframe: 2 months
Participants' suggestions to improve the intervention
Timeframe: 2 months
Participants' overall satisfaction with the intervention
Timeframe: 2 months
Feasibility: percentage of screened participants who are eligible
Timeframe: 6 months
Feasibility: percentage of eligible participants who enroll
Timeframe: 6 months
Feasibility: ability to randomize participants to study arms
Timeframe: 6 months
Feasibility: distribution of participants by demographics
Timeframe: 6 months
Feasibility: percentage of sessions attended
Timeframe: 6 months
Feasibility: participant adherence to study tasks include home mindfulness practices, self-monitoring activities
Timeframe: 6 months
Feasibility: barriers to participation in intervention sessions or completing study activities at home
Timeframe: 6 months
Feasibility: reasons for dropping out
Timeframe: 6 months
Feasibility: overall study retention
Timeframe: 6 months