Clinical trial NCT05577169: Incorporating Mind-body Skills With Diabetes Education in Adolescents With Type 1 Diabetes
Official title: Incorporating Mind-body Skills With Diabetes Education in Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Adolescent Behavior
Keywords: Type 1 diabetes
Adolescents
Mind-body skills
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2022-10-13
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention will have two arms - one group will receive diabetes education with the addition of mind-body skills, and the other group will receive only diabetes education.
Primary purpose: TREATMENT

Brief summary: Adolescence presents a challenging time for type 1 diabetes management, and despite a multitude of studies aimed at increasing disease compliance in this age group, none have been deemed superior. The purpose of this study is to incorporate mindfulness skills in with diabetes education sessions for adolescents with type 1 diabetes and study if this translates to improved outcomes in glycemic control, patient satisfaction, and mental wellness.

Detailed description: This is a pilot study to learn if adding mind-body skills to diabetes education is useful in helping adolescents manage their type 1 diabetes. Specifically, the investigators will be studying adolescents aged 15-17 years old with uncontrolled diabetes defined by an A1c \>9.0% who have also had the diagnosis of diabetes for at least 12 months. This study combines the teaching of mind-body skills with short virtual diabetes education sessions, in order to address both the direct needs of good diabetes management and the indirect needs of coping with diabetes-related stress and other external factors. The investigators will have two arms of the study - one receiving diabetes education with the addition of mind-body skills, and the other arm receiving only diabetes education. Sessions will be conducted virtually with 20-30 minutes of diabetes education, followed by 20-30 minutes of mind-body skills teaching in the respective arm. The study will consist of 10-12 weekly group sessions, with pre- and post-study questionnaires to evaluate mental and physical health. Participants will continue to attend their regular diabetes clinic appointments every three months. At the end of the study, participants will also partake in a short interview to gather feedback about their experience. The goals of this study are to evaluate the effect of mind-body skills as well as pilot test the feasibility and acceptability of such a project.

Eligibility criteria: Inclusion Criteria:

* Age 15-17 years
* Diagnosis of type 1 diabetes for at least 12 months
* Uncontrolled diabetes with A1c at least 9.0%
* Parent or guardian agrees for adolescent to participate

Exclusion Criteria:

* Diagnosed cognitive disabilities
* Other uncontrolled chronic diseases as assessed by PI
* Inability to attend visits due to individual schedules

Primary outcomes:
measure: Feasibility of intervention in the study population.
timeFrame: 12 months
measure: Acceptability of intervention in the study population.
timeFrame: 12 months
Secondary outcomes:
measure: Hemoglobin A1c (HbA1c, %)
timeFrame: 12 months
Other outcomes:
measure: Patient Health Questionnaire for Adolescents (PHQ-A)
timeFrame: 12 months
measure: Screen for Childhood Anxiety Related Emotional Disorders (SCARED-5) questionnaire
timeFrame: 12 months
measure: Problem Areas in Diabetes - Teens (PAID-T) questionnaire
timeFrame: 12 months
measure: Peds QL Diabetes Module questionnaire
timeFrame: 12 months
measure: Mindful Attention Awareness Scale (MAAS) questionnaire for adolescents
timeFrame: 12 months
measure: Difficulties in Emotion Regulation Scale (DERS) questionnaire
timeFrame: 12 months
measure: Child and Adolescent Social Support Scale (CASSS) questionnaire
timeFrame: 12 months
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
Study officials:
affiliation: Riley Hospital for Children at Indiana University Health
name: Tamara S. Hannon, MD
role: PRINCIPAL_INVESTIGATOR
References: