Diabetes Mellitus, Type 1NCT05115175
Acceptability of Self-Led Mindfulness-Based Intervention
A study testing Mindfulness-Based Stress Reduction in people with Diabetes Mellitus, Type 1, run by University of Nevada, Reno at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Mindfulness-Based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2019to 17 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 13-19 years old
- Type 1 diabetes diagnosis
- Currently attending school or a recent high school graduate
Who cannot join
- Ward of the state
- Severe psychiatric disturbances (e.g., active psychosis)
- Severe developmental delay that hindered ability to self-report
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness and Diabetes Distress: 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.
Read the 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
- Diabetes Mellitus, Type 1
- Being tested
- Mindfulness-Based Stress Reduction
- Keywords
- diabetes distress, adolescents, mindfulness, psychosocial intervention
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress ReductionBehavioural
Participants engaged in meditation and self-led exercises to help them understand and cope with stress.
| Study group | Role | What they receive |
|---|---|---|
| Intervention immediately | Experimental | The intervention 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. Topics included understanding stress, introduction to mindfulness, mindful eating and other mindfulness-based intervention 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 during the exercise. Receives: Behavioral: Mindfulness-Based Stress Reduction |
| Intervention in ten weeks following waitlist | Experimental | This group received the same intervention as the first arm, however, the participants in arm 2 received the intervention after a 10-week waitlist period. The intervention 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. Topics included understanding stress, introduction to mindfulness, mindful eating and other mindfulness-based intervention 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 during the exercise. Receives: Behavioral: Mindfulness-Based Stress Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Mindfulness as Assessed by Mindful Attention Awareness Scale-Adolescent (MAAS-A)
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.
Measured: 10 weeks intervention, 20 weeks waitlist
Change from Baseline in Engagement in Self-Compassionate Behavior as Assessed by Self-Compassion Scale (SCS)
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.
Measured: 10 weeks intervention, 20 weeks waitlist
Change from Baseline in Diabetes Stress as Assessed by Diabetes Stress Questionnaire (DSQ)
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.
Measured: 10 weeks intervention, 20 weeks waitlist
Change from Baseline in Health-Related Quality of Life as Assessed by Pediatric Quality of Life Inventory (PedsQL) 3.2 Diabetes Module
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.
Measured: 10 weeks intervention, 20 weeks waitlist
Change from Baseline in Perceived Stress as Assessed by Perceived Stress Scale-10 Item Version (PSS-10)
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.
Measured: 10 weeks intervention, 20 weeks waitlist
Change from Baseline in Psychosocial Impairment as Assessed by Pediatric Symptoms Checklist-17 (PSC-17)
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.
Measured: 10 weeks intervention, 20 weeks waitlist
Change from Baseline in Diabetes Treatment Engagement as Assessed by Self Care Inventory (SCI)
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.
Measured: 10 weeks intervention, 20 weeks waitlist
Change from Baseline in Glycosylated Hemoglobin Percentage
Assessed the difference in glycosylated hemoglobin percentage from pre-intervention to post-intervention.
Measured: 10 weeks intervention, 20 weeks waitlist
Engagement with the Scaled Mindfulness-Based Intervention as Assessed by Number of Weekly Surveys Completed.
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.
Measured: 20 weeks
Feasibility of the Scaled Mindfulness-Based Intervention as Assessed by Participant Feedback
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.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start14 Jul 2019
- Primary completion17 Apr 2020
- Study completion17 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Reno
- Sponsor type
- University, hospital or other
- Collaborators
- AlterMed Research foundation
- Responsible party
- Principal investigator, Holly Hazlett-Stevens, University of Nevada, Reno
- Investigators
- Holly Hazlett-Stevens, Ph.D., Principal investigator, University of Nevada, RenoAmy Hughes Lansing, Ph.D., Principal investigator, University of Nevada, Reno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115175
- Sponsor's protocol ID
- 1221205
- Status last verified
- Jul 2024
- First submitted
- 11 Oct 2021
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Overall analyses and scales can be shared as described in participant consent, however, individual participant data will not be shared.
Publications
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.
PubMed 30140143Brown KW, West AM, Loverich TM, Biegel GM. Assessing adolescent mindfulness: validation of an adapted Mindful Attention Awareness Scale in adolescent normative and psychiatric populations. Psychol Assess. 2011 Dec;23(4):1023-33. doi: 10.1037/a0021338. Epub 2011 Feb 14.
PubMed 21319908Neff 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.
PubMed 32125190Delamater 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.
PubMed 22913570Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Varni 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.
PubMed 30061317Gardner, 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.
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.
Humiston T, Cummings C, Suss S, Cohen LB, Hazlett-Stevens H, Hughes Lansing A. Acceptability of a Self-Led Mindfulness-Based Intervention for Teens with Type 1 Diabetes: Pilot Randomized Controlled Trial. JMIR Form Res. 2024 Jan 30;8:e45659. doi: 10.2196/45659.
PubMed 38289663
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness and Diabetes Distress: Acceptability of Self-Led Mindfulness-Based Intervention
- ClinicalTrials.gov ID
- NCT05115175
- Acronym / sponsor ID
- 1221205
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- diabetes distress, adolescents, mindfulness, psychosocial intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Nevada, RenoUniversity, hospital or other
- Collaborators
- AlterMed Research foundation
- Study start
- 14 Jul 2019 (actual)
- Primary completion
- 17 Apr 2020 (actual)
- Study completion
- 17 Jul 2020 (actual)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention immediately | Experimental | Behavioral: Mindfulness-Based Stress ReductionThe intervention 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. Topics included understanding stress, introduction to mindfulness, mindful eating and other mindfulness-based intervention 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 during the exercise. |
| Intervention in ten weeks following waitlist | Experimental | Behavioral: Mindfulness-Based Stress ReductionThis group received the same intervention as the first arm, however, the participants in arm 2 received the intervention after a 10-week waitlist period. The intervention 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. Topics included understanding stress, introduction to mindfulness, mindful eating and other mindfulness-based intervention 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 during the exercise. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Aged 13-19 years old
- Type 1 diabetes diagnosis
- Currently attending school or a recent high school graduate
Key exclusion criteria (3 listed)
- Ward of the state
- Severe psychiatric disturbances (e.g., active psychosis)
- Severe developmental delay that hindered ability to self-report
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Stress ReductionParticipants engaged in meditation and self-led exercises to help them understand and cope with stress. | Behavioural | Intervention immediately, Intervention in ten weeks following waitlist |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Background: PubMed 30140143Shubrook 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.
- Background: PubMed 21319908Brown KW, West AM, Loverich TM, Biegel GM. Assessing adolescent mindfulness: validation of an adapted Mindful Attention Awareness Scale in adolescent normative and psychiatric populations. Psychol Assess. 2011 Dec;23(4):1023-33. doi: 10.1037/a0021338. Epub 2011 Feb 14.
- Background: PubMed 32125190Neff 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.
- Background: PubMed 22913570Delamater 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.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 30061317Varni 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.
- BackgroundGardner, 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.
- BackgroundLa 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.
- Derived from this study: PubMed 38289663Humiston T, Cummings C, Suss S, Cohen LB, Hazlett-Stevens H, Hughes Lansing A. Acceptability of a Self-Led Mindfulness-Based Intervention for Teens with Type 1 Diabetes: Pilot Randomized Controlled Trial. JMIR Form Res. 2024 Jan 30;8:e45659. doi: 10.2196/45659.
- Individual participant dataSharing planned: No. Overall analyses and scales can be shared as described in participant consent, however, individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly Hazlett-Stevens, Ph.D. principal investigator
University of Nevada, Reno
Amy Hughes Lansing, Ph.D. principal investigator
University of Nevada, Reno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction in people with Diabetes Mellitus, Type 1, run by University of Nevada, Reno at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Mindfulness as Assessed by Mindful Attention Awareness Scale-Adolescent (MAAS-A) (time frame: 10 weeks intervention, 20 weeks waitlist). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05115175, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.