CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 400 enrolled
Drug / intervention
Positive Affect + Education +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03845465
NCT03845465N/ACompleted

Positive Psychology Intervention to Treat Diabetes Distress in Teens With Type 1 Diabetes

Vanderbilt University Medical Center·interventional·Posted Feb 19, 2019·Updated Mar 21, 2025

In Brief

A clinical study evaluating Positive Affect + Education and Education for Type 1 Diabetes Mellitus. Completed, enrolled 400 participants across 2 sites.

Detailed Summary

The treatment regimen for type 1 diabetes is complex and demanding, and many adolescents experience diabetes distress related to the daily demands of diabetes care, which can cause problems with diabetes management and glycemic control. The proposed study will conduct a multisite, randomized trial to test the effects of a positive psychology intervention aimed at treating diabetes distress and improving glycemic outcomes. The potential benefits include helping adolescents achieve better glycemic control, improved self-management, and psychosocial outcomes

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 19, 2019
Enrollment StartDec 17, 2019
Primary CompletionAug 23, 2023
Study CompletionSep 7, 2023
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 7.4 years ago

Interventions

Positive Affect + Educationbehavioral

Adolescents will complete a health behavior contract and receive an educational packet at baseline. Adolescents will complete a positive affect interview at baseline. They will receive automated text messages 5 days/week for 8 weeks. Messages will be tailored to include adolescents' responses to the baseline interview, including reminders to engage in gratitude and self-affirmation. Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths.

Educationbehavioral

Adolescents will complete a health behavior contract and receive an educational packet with information about diabetes management.