Mindfulness and Diabetes Distress: Acceptability of Self-Led Mindfulness-Based Intervention
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Sponsor: University of Nevada, Reno

 
 
 
Study title: Mindfulness and Diabetes Distress: Acceptability of Self-Led 
Mindfulness-Based Intervention 
 
 
Document Date: Study Protocol last approved by the University of Nevada, Reno 
Institutional Review Board on 12/13/2019; Statistical Analysis Plan last approved 
by the University of Nevada, Reno Institutional Review Board on 04/19/2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

1. Study Protocol 
Objectives 
This study had two primary aims. First, to examine the associations of mindfulness and 
diabetes-related outcomes, and second, to examine the acceptability, feasibility, and potential 
utility of self-led mindfulness-based stress reduction (MBSR) intervention.  
Participants 
Participants for the present study included a sample of 25 adolescents (14 females; 
56%), 14-18 years old (M= 16.25, SD= 1.6 years) from urban and rural areas of Nevada. Most 
participants identified as White (n=22; 88%) and one participant as Asian, one participant as 
Native Hawaiian or Pacific Islander, and one participant as bi-racial. Participants reported a 
wide range of diagnosis length, ranging from less than a year to 16.15 years (M=5.3, SD=4.1). 
Nineteen participants reported using a continuous blood glucose monitor (76%) and 17 
endorsed using an insulin pump (68%). Additionally, 10 participants reported that they qualify 
for free lunch at school (40%). Participants were asked to report on psychopathology and other 
medications that may impact attention for mindfulness activities. Inclusion criteria included 
being an adolescent (aged 13-19) with a type 1 diabetes diagnosis and currently attending 
school or being a recent high school graduate. Participants were excluded if they were a ward 
of the state, or had severe psychiatric disturbances (e.g., active psychosis) or severe 
developmental delay that hindered their ability to self-report. Participants were not excluded 
based on length of type 1 diabetes diagnosis. Trained undergraduate research staff screened 
participants for eligibility during the consent process. 
Procedures 

Procedures were approved by the Institutional Review Board at the University of 
Nevada, Reno. Electronic parental consent was obtained when the child was under the age of 
18, in which case child assent was also obtained. Participants 18 and older provided electronic 
consent. Participants were recruited with flyers at a regional diabetes camp, flyers to 
community diabetes support groups, and direct recruitment by research staff in a local 
pediatric endocrinology clinic to obtain participants from both urban and rural areas of Nevada. 
Recruitment for this parallel pilot trial began in the fall of 2018 and completed in early spring 
2020. All enrolled participants completed a baseline survey and were randomized to either 
begin the 10-week intervention period immediately or in 10-weeks. Based on prior studies of 
predictors of glycemic levels and treatment response, randomization was computerized and 
stratified based on gender, length since type 1 diabetes diagnosis (at or below 2 years versus 
more than 2 years) and most recent HbA1c (at or below 8.5% versus at or above 8.6%). After 
the baseline assessment and across the initial and waitlist intervention periods, participants 
also completed assessment questionnaires 10 weeks and 20 weeks after the study start date.   
Research staff were trained by two graduate students on recruitment procedures and 
eligibility criteria. Sixty-four participants contacted our research staff indicating interest in 
participating in the study and provided permission to contact either online or in person (See 
Figure 1). During the study period, an interim study endpoint was reached where it was 
determined due to attrition and loss to follow-up as well as feedback from the enrolled 
participants (n = 29) that the intervention required revision to increase acceptability. Thus, 
enrollment was stopped prior to reaching the planned, per a priori power analyses, sixty 
participants. Of the 64 participants that indicated interested in the study, five participants 

declined further screening and two participants were not eligible after screening. At the interim 
stop point, 29 participants had been consented and enrolled in the study. An additional 28 
participants expressed interest in enrolling but did not complete the consent process before 
the interim study endpoint was reached. Among the 29 enrolled participants, 25 participants 
completed their baseline survey and were randomized to intervention now (n=15) or waitlist 
(n=10); groups were not balanced as enrollment was stopped early. Four of the 29 participants 
passively declined to complete the baseline survey and were not randomized. During the 
course of the study, two participants withdrew from the study after intake (reasons: busy with 
school, study participation was stressful), but nine were lost to follow-up at 10-weeks and 
another six were lost to follow-up at 20-weeks.  
Intervention Program. The mindfulness-based intervention in the present study was 
delivered via a teen MBSR workbook and online communication across the 10-week 
intervention period. Participants were assigned weekly readings and activities from an MBSR 
workbook for teens (Biegel, 2017). Topics included understanding stress, introduction to 
mindfulness, mindful eating and other mindfulness-based principles and were recommended to 
be completed daily. Mindfulness-based exercises were either self-led per instructions provided 
in the workbook or to be completed using an audio recording directing participants’ behaviors. 
Participants received emails twice per week with reminders about their assignments for the 
upcoming week and reminders to practice mindfulness daily. At the end of the week, 
participants received a reminder to complete a brief survey to obtain qualitative data regarding 
the acceptability of that week’s content. Qualitative feedback regarding participants’ 
acceptability of the workbook were used in analyses and included open-ended questions 

regarding how helpful participants found each exercise and what hindered them from 
completing the exercises.  
Participants could earn $10 for each assessment questionnaire, $10 for completing at 
least six of the ten weekly survey over the ten-week intervention period, and an additional $10 
for completing all 10 weekly surveys. Maximum earning for each participant was $50. All 
measures were completed electronically through RedCap. 
Measures 
Mindful Attention Awareness Scale-Adolescent. The Mindful Attention Awareness 
Scale-Adolescent (MAAS-A; Brown et al., 2011), adapted from the MAAS for adults (Brown & 
Ryan, 2003), assesses dispositional mindfulness in adolescents. The MAAS-A 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. The MAAS-A has high internal consistency and test-
retest reliability as well as both concurrent and incremental validity (Brown et al., 2011) with 
strong internal consistency in the study sample (a = .92).  
Self-Compassion Scale. The Self-Compassion Scale (SCS; Neff, 2003) is a 26-item 
measure that assesses different aspects of self-compassion in individuals 14 and older. 
Participants rate how often they engage in each self-compassionate behavior in specific 
situations (for example, “When I fail at something important to me, I try to keep things in 
perspective”). The SCS is rated on a 5-point scale (1 = almost never, 5 = almost always). Total 
score is calculated by computing the sum of all items. The SCS has been shown to have good 
internal consistency (a = 0.92) and convergent validity with adolescents (Cunha, Xavier & 
Castilho, 2016) and had strong internal consistency in this sample (a = .95). 

Diabetes Distress. The Diabetes Stress Questionnaire (DSQ; Delamater et al., 2013) 
assesses different daily, diabetes-specific stressors. The measure 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). A total score is calculated by 
computing the mean of all items in addition to the mean score for each subscale. The DSQ has 
high internal consistency (a > 0.7) and strong convergent validity (0.46 < r > 0.77; Kamody et al., 
2014) and had strong internal consistency in this sample (a = .97). 
Health-related Quality of Life. The PedsQL 3.2 -Diabetes Module (PedsQL- DM; Varni et 
al., 2018) assesses diabetes-specific, health-related quality of life in children, adolescents, and 
young adults. Each item is rated on a 5-point scale (0 = never, 4 = almost always). Summary 
scores are calculated by computing the sum of all items divided by the total number of items 
answered. The PedsQL-DM has strong internal consistency and construct validity (Varni et al., 
2018) and had strong internal consistency in this sample (a = .92). 
Perceived Stress. The Perceived Stress Scale-10 Item Version (PSS-10; Cohen, Kamarack, 
& Mermelstein, 1982) assesses the severity of broad, stressful situations. 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. The PSS-10 has well-documented reliability and validity (a = 
0.84; Perera et al., 2017) and had strong internal consistency in this sample (a = .93). 
Psychosocial Impairment. The Pediatric Symptoms Checklist-17 (PSC-17; Gardner et al., 
1999) assesses a child’s psychosocial functioning. The present study uses the self-report PSC-17, 
consisting of three subscales. 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 dysfunction. The PSC-17 has strong concurrent validity and high 
internal constancy (a = 0.89; Murphy et al., 2016) and had sufficient internal consistency in this 
sample (a = .86). 
Diabetes Treatment Engagement. The Self Care Inventory (SCI), originally developed by 
La Greca et al. (1988), was modified to include eight additional items reflecting modern 
diabetes management behaviors (Helgeson et al., 2007). The SCI assesses to what degree 
individuals follow health care provider guidelines for diabetes-management behaviors. 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 SCI consisted of 22 items and is rated on a 5-point scale (1 = never, 5 = always). A 
total score is calculated by computing the average of all of the items. The modified version of 
the SCI has high internal consistency (a = 0.78-0.82) and is highly correlated with the original SCI 
(Helgeson et al., 2010) and had sufficient internal consistency in this sample (a = .88).   
Glycosylated hemoglobin percentage (HbA1c). At intake, participants self-reported 
their most recent HbA1c. Higher HbA1c percentages are associated with less optimal glycemic 
control in the past two to three months. 
 
2. Statistical Analysis Plan 
The aim of the present study was two-fold. First, to examine the association between 
mindfulness, diabetes distress, Hba1c, self-compassion, general perceived stress, diabetes 
treatment engagement, and diabetes-related quality of life, the investigators used baseline 

assessment data from all randomized participants and conducted Pearson correlations. 
Additionally, to inform what aspects of mindfulness are most connected with diabetes distress, 
the investigators explored the associations of each item on the MAAS-A scale with diabetes 
distress ratings. Second, to assess the feasibility, acceptability and utility of the self-led MBSR 
intervention for adolescents with type 1 diabetes the investigators examined attrition and the 
number of weekly surveys completed as well as feedback from the participants during the 
study.  
To further consider the potential utility of the self-led MBSR intervention in this 
population, the investigators examined changes in the primary outcomes of mindfulness and 
diabetes related-stress at baseline and 10-week follow-up between the intervention and 
waitlist groups using independent sample t-tests and from pre-to post-intervention in high 
engagement participants (those who completed at least six of 10 weekly surveys) using paired 
sample t-tests. To limit bias from missing data at 10-week follow-up (n = 11) in independent 
sample t-tests an intent-to-treat approach was used, where the baseline level of mindfulness 
and diabetes-stress was used as the 10-week level for missing data rather than excluding those 
participants from analyses. The same intent to treat approach was used for the assessment of 
pre-to post-intervention changes in high engagement participants using paired sample t-tests. 
 
 
 
 
 

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