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Positive Psychology Intervention to Treat Diabetes Distress in Teens With Type 1 Diabetes (T1D)

Vanderbilt University Medical Center logo

Vanderbilt University Medical Center

Status

Completed

Conditions

Type 1 Diabetes Mellitus

Treatments

Behavioral: Positive Affect + Education
Behavioral: Education

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

400 patients

Sex

All

Ages

13 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

400 participants in 2 patient groups

Education
Active Comparator group
Description:
Participants in the Education group will complete a behavioral health contract and will receive an educational packet.
Treatment:
Behavioral: Education
PA + Education
Experimental group
Description:
Participants in the Positive Affect + Education group will complete a behavioral health contract and receive an educational packet. In addition, they will receive intervention components aimed at inducing positive affect.
Treatment:
Behavioral: Education
Behavioral: Positive Affect + Education

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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