N/A
N=5
Intervention Mapping to Adapt a Mindfulness-based Intervention for Adults With Diabetes and Emotional Distress
Type 2 Diabetes · Stress
Bottom Line
View on ClinicalTrials.gov: NCT03987841 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Diabetes Distress — 2.64 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Integrated MBSR/DSME intervention (Behavioral)
- Age
- Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diabetes Distress |
2.19 | — |
| PRIMARY Diabetes Distress |
2.19 | — |
| PRIMARY Hemoglobin A1c (A1C) |
7.24 | — |
| PRIMARY Hemoglobin A1c (A1C) |
7.24 | — |
| SECONDARY Diabetes Self-management Behaviors |
4.4; 3.1; 4.7; 5.4 | — |
| SECONDARY Diabetes Self-management Behaviors |
4.4; 3.1; 4.7; 5.4 | — |
| SECONDARY Medication Adherence |
16.2 | — |
| SECONDARY Medication Adherence |
16.2 | — |
| SECONDARY Acceptability of the Intervention to Participants: Semi-structured Interviews |
5; 5; 5; 5; 5; 5 | — |
| SECONDARY Feasibility: Percentage of Screened Participants Who Are Eligible |
11 | — |
| SECONDARY Feasibility: Percentage of Eligible Participants Who Enroll |
5 | — |
| SECONDARY Feasibility: Distribution of Participants by Demographics |
1; 3; 1 | — |
| SECONDARY Feasibility: Percentage of Sessions Attended |
3; 1; 1 | — |
Summary
We will conduct a single-arm pilot study of an integrated mindfulness-based stress reduction (MBSR)/diabetes self-management education (DSME) intervention in a small group of participants, low-income adults with type 2 diabetes and diabetes distress. We will evaluate the preliminary efficacy, acceptability, and feasibility of the intervention.
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes
- Receipt of care at Cooper Green Mercy Healthcare System (CGMHS), one or more visits to primary care or diabetes clinic within the prior year
- An elevated point-of-care hemoglobin A1c (A1C) ≥7.5
- Presence of moderate diabetes distress (indicated by a score of ≥2 on the Diabetes Distress Scale)
Exclusion Criteria
- Non-English speaking
- Currently pregnant
- Personal history or prior diagnosis of bipolar disorder, schizophrenia, or psychosis
Data sourced from ClinicalTrials.gov (NCT03987841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.