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Clinical Trials/NCT03845465
NCT03845465
Completed
N/A

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

Vanderbilt University Medical Center2 sites in 1 country400 target enrollmentDecember 17, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Type 1 Diabetes Mellitus
Sponsor
Vanderbilt University Medical Center
Enrollment
400
Locations
2
Primary Endpoint
Hemoglobin A1c
Status
Completed
Last Updated
last year

Overview

Brief 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

Detailed Description

Adolescents with type 1 diabetes (T1D) struggle to meet treatment goals - only 17% met the target for glycemic control in a recent national study - and many adolescents experience high levels of diabetes distress related to the daily demands of diabetes care. Yet, previous interventions to improve glycemic control in adolescents with type 1 diabetes have only shown modest to moderate effects, and many have been time-intensive and expensive. Thus, there is a need for novel interventions to improve outcomes in adolescents with T1D. Increasing positive affect, or pleasurable engagement with the environment (e.g., feeling happy, cheerful, proud), has been shown to promote the use of more adaptive coping strategies to manage stress. Thus, the proposed study is based on the premise that, by boosting positive affect in teens with diabetes, we will enhance the use of adaptive coping strategies and reduce diabetes distress, thereby improving glycemic control in adolescents. Through an iterative series of pilot studies, our research team adapted a behavioral intervention using a positive psychology framework that we demonstrated to be feasible and acceptable for adolescents with T1D. This intervention is aimed at inducing positive affect in adolescents (age 13-17) through empirically-validated, tailored exercises in gratitude, self-affirmation, and caregiver affirmations. In our pilot studies, the intervention had promising effects on adolescents' quality of life, diabetes-related stress, and family conflict, all of which are closely linked with diabetes distress. We now plan to evaluate the efficacy of the intervention in a multisite, randomized controlled trial. The aims of this study are to 1) evaluate the effects of a positive psychology intervention for adolescents (age 13-17) and their caregivers on glycemic control; 2) evaluate the effects of the intervention on diabetes distress, coping, and self-care behavior; and 3) explore the differential impact of intervention effects across demographic and treatment variables. We plan to randomize 200 adolescent-caregiver dyads to the Positive Affect + Education intervention (n=100) or the Education only intervention (n=100) from two clinical sites (Vanderbilt University Medical Center and Children's National Medical Center). By employing a positive psychology framework, we propose an innovative approach to treat diabetes distress and improve glycemic outcomes. We believe this novel intervention has the potential to improve outcomes in adolescents with T1D, and the use of automated text messaging to deliver the intervention offers possibilities for wide dissemination.

Registry
clinicaltrials.gov
Start Date
December 17, 2019
End Date
September 7, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sarah Jaser

Associate Professor

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Age 13-17
  • Diagnosed with type 1 diabetes for at least 12 months
  • Speak and read English
  • Report at least moderate diabetes distress on the Problem Areas in Diabetes Scale - Teen version

Exclusion Criteria

  • Other serious health conditions

Outcomes

Primary Outcomes

Hemoglobin A1c

Time Frame: 3 months

Hemoglobin A1c measures the amount of glucose attached to hemoglobin. It is assessed as part of regular diabetes clinic visits. The target is \<7.0%.

Secondary Outcomes

  • Diabetes Distress(3 months)
  • Primary Control Coping(3 months)
  • Positive Affect(3 months)
  • Secondary Control Coping(3 months)
  • Disengagement Coping(3 months)
  • Diabetes Self-Care Behavior(3 months)
  • Diabetes-Related Quality of Life(3 months)

Study Sites (2)

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