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NCT03987841 · ClinicalTrials.gov registry record · NA

Intervention Mapping to Adapt a Mindfulness-based Intervention for Adults With Diabetes and Emotional Distress

A NA study of Type 2 Diabetes and Stress, sponsored by University of Alabama at Birmingham.

Completed
Registry status
NA
Development phase
5
Enrollment target
1
Study location

NCT03987841: Completed NA study of Type 2 Diabetes and Stress, sponsored by University of Alabama at Birmingham.

NCT03987841 is a NA study of Type 2 Diabetes and Stress that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 5 participants, below the 3,924-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03987841, a NA study of Type 2 Diabetes and Stress, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
NA
Development phase
5 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Measured by the diabetes distress scale (DDS), a 17-item self-report measure, assessing domains of emotional burden, physician-related distress, regimen-related distress, and interpersonal distress. The questionnaire will be administered to participants in English by a trained interviewer. The mean item score yields a possible score from 1 to 6; a score of \<2 indicates little/no distress, 2 to 2.9 moderate distress, and ≥3 high distress.

Conditions Studied

Type 2 Diabetes Stress

Interventions

  • BEHAVIORAL Integrated MBSR/DSME intervention

Study Locations (1)

Alabama

  • Cooper Green Mercy Health Systems - Birmingham

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2021-10-01
Est. Completion 2022-06-30
Phase NA
University of Alabama at Birmingham

1,160 total trials

What the finished NCT03987841 record still lists

NCT03987841 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 3,924-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (100% lower).

The record links to 2 conditions, with Type 2 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which Integrated MBSR/DSME intervention is the first listed.

NCT03987841 reports a single indexed study location in Alabama.

Frequently Asked Questions

What is clinical trial NCT03987841 about?

NCT03987841 is a clinical study titled "Intervention Mapping to Adapt a Mindfulness-based Intervention for Adults With Diabetes and Emotional Distress". 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, accept...

What is the current status of trial NCT03987841?

This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2021-10-01. Estimated completion is 2022-06-30.

What conditions does trial NCT03987841 study?

This clinical trial studies the following conditions: Type 2 Diabetes, Stress.

What interventions are being tested in trial NCT03987841?

The interventions under investigation include: Integrated MBSR/DSME intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT03987841?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03987841 being conducted?

This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Type 2 Diabetes

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03987841's enrollment target sits among peer trials

5 327th of 327 higher than 1 of 327 other Type 2 Diabetes trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Type 2 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03987841, the US trial registry maintained by the National Library of Medicine. NCT03987841 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.