Clinical Trials Directory

Trials / Completed

CompletedNCT05115175

Acceptability of Self-Led Mindfulness-Based Intervention

Mindfulness and Diabetes Distress: Acceptability of Self-Led Mindfulness-Based Intervention

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
29 (actual)
Sponsor
University of Nevada, Reno · Academic / Other
Sex
All
Age
13 Years – 19 Years
Healthy volunteers
Accepted

Summary

This study had two primary aims. First, the investigators examined the associations between mindfulness and diabetes-related outcomes. It was hypothesized that at baseline, increased mindfulness would be associated with decreased diabetes distress and more optimal glycemic levels and that all three variables would share similar associations with related constructs including greater self-compassion, lower general stress, better psychosocial health, increased diabetes treatment engagement, and greater diabetes-related quality of life. The association between specific aspects of dispositional mindfulness and diabetes distress was also explored. Second, the investigators examined the acceptability, feasibility, and potential utility of self-led MBSR intervention. It was hypothesized that participation in a self-led MBSR intervention would be feasible and acceptable, evidenced by treatment attrition and participant feedback. It was also hypothesized that participants who received the self-led Mindfulness-based stress reduction (MBSR) intervention would experience increased mindfulness and decreased diabetes distress compared to a waitlist control group.

Detailed description

The goal of the present study was to assess the associations of dispositional mindfulness, diabetes distress, and glycemic outcomes for adolescents with type 1 diabetes as well as to use an iterative approach to developing a self-led scalable mindfulness-based intervention. A self-led mindfulness-based intervention may provide a mindfulness practice to help adolescents with type 1 diabetes improve glycemic outcomes through diabetes distress reduction while also being practical within a pediatric endocrinology clinic. A self-led intervention may also reduce the burden associated with mindfulness-based interventions. This is important considering the heightened emotional and time burden adolescents may already experience due to disease management and the intensity of a traditional mindfulness-based intervention. This study had two primary aims. First, the investigators examined the associations between mindfulness and diabetes-related outcomes. It was hypothesized that at baseline, increased mindfulness would be associated with decreased diabetes distress and more optimal glycemic levels and that all three variables would share similar associations with related constructs including greater self-compassion, lower general stress, better psychosocial health, increased diabetes treatment engagement, and greater diabetes-related quality of life. The association between specific aspects of dispositional mindfulness and diabetes distress was also explored. Second, the investigators examined the acceptability, feasibility, and potential utility of self-led MBSR intervention. It was hypothesized that participation in a self-led MBSR intervention would be feasible and acceptable, evidenced by treatment attrition and participant feedback. It was also hypothesized that participants who received the self-led MBSR intervention would experience increased mindfulness and decreased diabetes distress compared to a waitlist control group.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMindfulness-Based Stress ReductionParticipants engaged in meditation and self-led exercises to help them understand and cope with stress.

Timeline

Start date
2019-07-14
Primary completion
2020-04-17
Completion
2020-07-17
First posted
2021-11-10
Last updated
2024-08-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05115175. Inclusion in this directory is not an endorsement.