Clinical trial NCT05115175: Acceptability of Self-Led Mindfulness-Based Intervention
Official title: Mindfulness and Diabetes Distress: Acceptability of Self-Led Mindfulness-Based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: diabetes distress
adolescents
mindfulness
psychosocial intervention
Lead sponsor: University of Nevada, Reno
Sponsor class: OTHER
Collaborators: name: AlterMed Research foundation
First posted: 2021-11-10
Enrollment: 29
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adolescents (N=25) aged 14 to 18 diagnosed with type 1 diabetes completed a baseline assessment. Participants were randomized to receive a 10-week self-guided mindfulness-based stress reduction program immediately (n=10) or after a 10-week wait (n=15). During the intervention period, participants completed weekly assignments and qualitative and quantitative feedback surveys. At 10-weeks and 20-weeks follow-up assessments were completed.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Mindfulness as Assessed by Mindful Attention Awareness Scale-Adolescent (MAAS-A)
timeFrame: 10 weeks intervention, 20 weeks waitlist
measure: Change from Baseline in Engagement in Self-Compassionate Behavior as Assessed by Self-Compassion Scale (SCS)
timeFrame: 10 weeks intervention, 20 weeks waitlist
measure: Change from Baseline in Diabetes Stress as Assessed by Diabetes Stress Questionnaire (DSQ)
timeFrame: 10 weeks intervention, 20 weeks waitlist
measure: Change from Baseline in Health-Related Quality of Life as Assessed by Pediatric Quality of Life Inventory (PedsQL) 3.2 Diabetes Module
timeFrame: 10 weeks intervention, 20 weeks waitlist
measure: Change from Baseline in Perceived Stress as Assessed by Perceived Stress Scale-10 Item Version (PSS-10)
timeFrame: 10 weeks intervention, 20 weeks waitlist
measure: Change from Baseline in Psychosocial Impairment as Assessed by Pediatric Symptoms Checklist-17 (PSC-17)
timeFrame: 10 weeks intervention, 20 weeks waitlist
measure: Change from Baseline in Diabetes Treatment Engagement as Assessed by Self Care Inventory (SCI)
timeFrame: 10 weeks intervention, 20 weeks waitlist
measure: Change from Baseline in Glycosylated Hemoglobin Percentage
timeFrame: 10 weeks intervention, 20 weeks waitlist
measure: Engagement with the Scaled Mindfulness-Based Intervention as Assessed by Number of Weekly Surveys Completed.
timeFrame: 20 weeks
measure: Feasibility of the Scaled Mindfulness-Based Intervention as Assessed by Participant Feedback
timeFrame: 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Reno
country: United States
facility: University of Nevada, Reno
state: Nevada
Study officials:
affiliation: University of Nevada, Reno
name: Holly Hazlett-Stevens, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nevada, Reno
name: Amy Hughes Lansing, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shubrook JH, Brannan GD, Wapner A, Klein G, Schwartz FL. Time Needed for Diabetes Self-Care: Nationwide Survey of Certified Diabetes Educators. Diabetes Spectr. 2018 Aug;31(3):267-271. doi: 10.2337/ds17-0077.
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citation: Neff KD, Bluth K, Toth-Kiraly I, Davidson O, Knox MC, Williamson Z, Costigan A. Development and Validation of the Self-Compassion Scale for Youth. J Pers Assess. 2021 Jan-Feb;103(1):92-105. doi: 10.1080/00223891.2020.1729774. Epub 2020 Mar 3.
citation: Delamater AM, Patino-Fernandez AM, Smith KE, Bubb J. Measurement of diabetes stress in older children and adolescents with type 1 diabetes mellitus. Pediatr Diabetes. 2013 Feb;14(1):50-6. doi: 10.1111/j.1399-5448.2012.00894.x. Epub 2012 Aug 23.
citation: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
citation: Varni JW, Delamater AM, Hood KK, Raymond JK, Chang NT, Driscoll KA, Wong JC, Yi-Frazier JP, Grishman EK, Faith MA, Corathers SD, Kichler JC, Miller JL, Doskey EM, Heffer RW, Wilson DP; Pediatric Quality of Life Inventory 3.2 Diabetes Module Testing Study Consortium. PedsQL 3.2 Diabetes Module for Children, Adolescents, and Young Adults: Reliability and Validity in Type 1 Diabetes. Diabetes Care. 2018 Oct;41(10):2064-2071. doi: 10.2337/dc17-2707. Epub 2018 Jul 30.
citation: Gardner, W., Murphy, M., Childs, G., Kelleher, K., Pagano, M., Jellinek, M., ... & Chiappetta, L. (1999). The PSC-17: A brief pediatric symptom checklist with psychosocial problem subscales. A report from PROS and ASPN. Ambulatory Child Health, 5, 225-225.
citation: La Greca, A., Swales, T., Klemp, S., & Madigan, S. (1988). Self-care behaviors among adolescents with diabetes. Proceedings of the Ninth Annual Sessions of the Society of Behavioral Medicine.