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NCT Number: NCT05115175

Acceptability of Self-Led 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 Mindfulness-based stress reduction (MBSR) intervention would experience increased mindfulness and decreased diabetes distress compared to a waitlist control group.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nevada, Reno

Reno, Nevada, 89557, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 13-19 years old
  • Type 1 diabetes diagnosis
  • Currently attending school or a recent high school graduate

Exclusion criteria

  • Ward of the state
  • Severe psychiatric disturbances (e.g., active psychosis)
  • Severe developmental delay that hindered ability to self-report

Treatment and study plan

Mindfulness-Based Stress Reduction

Behavioral

Participants engaged in meditation and self-led exercises to help them understand and cope with stress.

Primary outcomes

  1. Change from Baseline in Mindfulness as Assessed by Mindful Attention Awareness Scale-Adolescent (MAAS-A)

    Time frame: 10 weeks intervention, 20 weeks waitlist

    Assessed difference in dispositional mindfulness in adolescents from pre-intervention to post-intervention. The Mindful Attention Awareness Scale-Adolescent has a single-factor structure with 14 items rated on a 6-point scale (1 = almost always, 6 = almost never). Higher scores indicate higher trait mindfulness.

  2. Change from Baseline in Engagement in Self-Compassionate Behavior as Assessed by Self-Compassion Scale (SCS)

    Time frame: 10 weeks intervention, 20 weeks waitlist

    Participants rated how often they engage in each self-compassionate behavior in specific situations pre- and post-intervention. The Self-Compassion Scale is a 26-item measure rated on a 5-point scale (1 = almost never, 5 = almost always). Higher scores indicate higher self-compassion.

  3. Change from Baseline in Diabetes Stress as Assessed by Diabetes Stress Questionnaire (DSQ)

    Time frame: 10 weeks intervention, 20 weeks waitlist

    Assessed different daily, diabetes-specific stressors from pre-intervention to post-intervention. The Diabetes Stress Questionnaire consists of 65 items and includes eight subscales. Participants rate severity of stress across several diabetes-related scenarios on a 4-point scale (0 = not at all, 3 = very much). Higher scores indicate higher diabetes distress.

  4. Change from Baseline in Health-Related Quality of Life as Assessed by Pediatric Quality of Life Inventory (PedsQL) 3.2 Diabetes Module

    Time frame: 10 weeks intervention, 20 weeks waitlist

    Assessed diabetes-specific, health-related quality of life in children, adolescents, and young adults from pre-intervention to post-intervention. The Pediatric Quality of Life Inventory 3.2 Diabetes Module consists of 33 items rated on a 5-point scale (0 = never, 4 = almost always). Higher scores indicate greater quality of life.

  5. Change from Baseline in Perceived Stress as Assessed by Perceived Stress Scale-10 Item Version (PSS-10)

    Time frame: 10 weeks intervention, 20 weeks waitlist

    Assessed the severity of broad, stressful situations in adolescents from pre-intervention to post-intervention. Participants rank how often each statement applies to their feelings of stress on a 5-point scale (0 = never, 4 = very often). Negative items are reversed and the sum of all 10 items is calculated. Higher scores indicate higher perceived stress.

  6. Change from Baseline in Psychosocial Impairment as Assessed by Pediatric Symptoms Checklist-17 (PSC-17)

    Time frame: 10 weeks intervention, 20 weeks waitlist

    Assessed psychosocial functioning from pre-intervention to post-intervention. Participants rate how frequently each symptom occurs on a 3-point scale (0 = never, 2 = often). Total scores range from 0-34 with higher scores indicating greater risk of psychosocial impairment.

  7. Change from Baseline in Diabetes Treatment Engagement as Assessed by Self Care Inventory (SCI)

    Time frame: 10 weeks intervention, 20 weeks waitlist

    Assessed to what degree individuals follow health care provider guidelines for diabetes-management behaviors from pre-intervention to post-intervention. The investigators removed the item "how frequently do you come in for appointments" from the study as the measure was not used within a physician/ appointment context. After removing the item, the Self Care Inventory consisted of 22 items and is rated on a 5-point scale (1 = never, 5 = always). Higher scores indicate higher diabetes treatment engagement.

  8. Change from Baseline in Glycosylated Hemoglobin Percentage

    Time frame: 10 weeks intervention, 20 weeks waitlist

    Assessed the difference in glycosylated hemoglobin percentage from pre-intervention to post-intervention.

  9. Engagement with the Scaled Mindfulness-Based Intervention as Assessed by Number of Weekly Surveys Completed.

    Time frame: 20 weeks

    Assessed the number of weekly surveys each participant completed during the intervention period. Participants were asked to complete at least 6 out of the 10 weekly surveys during the intervention period to be considered highly engaged.

  10. Feasibility of the Scaled Mindfulness-Based Intervention as Assessed by Participant Feedback

    Time frame: 20 weeks

    Assessed the acceptability and feasibility of a mindfulness-based intervention for teens with type 1 diabetes by examining participant feedback on reasons for attrition and low engagement. Weekly feedback surveys asked about barriers to engaging in the weekly material.

Sponsors and collaborators

Lead sponsor

University of Nevada, Reno

Other

Collaborators

  • AlterMed Research foundation

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 10, 2021
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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