Positive Psychology Intervention to Treat Diabetes Distress in Teens With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

Intervention name(s): Positive Affect + Education; Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; Adolescents will complete a health behavior contract and receive an educational packet with information about diabetes management.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment