Intervention Mapping to Adapt a Mindfulness-based Intervention for Adults With Diabetes and Emotional Distress
NCT ID: NCT03987841
Last Updated: 2023-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2021-10-01
2022-06-30
Brief Summary
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Detailed Description
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Participants will be assessed at baseline and 2 months. We will assess the preliminary efficacy of the intervention through pre/post evaluation of diabetes distress, diabetes self-management behaviors, and glycemic control as measured by hemoglobin A1c. Additionally, we will assess acceptability of the intervention through follow-up qualitative, focus groups with intervention participants; the feasibility of intervention delivery will be assessed using process measures.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Integrated MBSR/DSME intervention
Integrated mindfulness-based stress reduction/diabetes self-management education intervention. Single-arm study, a group of participants meeting eligibility requirements will be invited to participate.
Integrated MBSR/DSME intervention
Integrated mindfulness-based stress reduction/diabetes self-management education intervention. The intervention will comprise components of MBSR and DSME and will be delivered in a group setting with 8 weekly sessions. A trained masters-level interventionist will deliver the integrated intervention.
Interventions
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Integrated MBSR/DSME intervention
Integrated mindfulness-based stress reduction/diabetes self-management education intervention. The intervention will comprise components of MBSR and DSME and will be delivered in a group setting with 8 weekly sessions. A trained masters-level interventionist will deliver the integrated intervention.
Eligibility Criteria
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Inclusion Criteria
* 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
* Currently pregnant
* Personal history or prior diagnosis of bipolar disorder, schizophrenia, or psychosis
19 Years
64 Years
ALL
No
Sponsors
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National Center for Advancing Translational Sciences (NCATS)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
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Caroline Presley
Principal Investigator
Principal Investigators
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Caroline A Presley, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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Cooper Green Mercy Health Systems
Birmingham, Alabama, United States
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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IRB-300003578
Identifier Type: -
Identifier Source: org_study_id
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