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

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ClinicalTrials.gov Identifier: NCT03845465
Recruitment Status : Not yet recruiting
First Posted : February 19, 2019
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
Children's Research Institute
Information provided by (Responsible Party):
Sarah Jaser, Vanderbilt University Medical Center

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

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Behavioral: Check It Behavioral: Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Positive Psychology Intervention to Treat Diabetes Distress in Teens With Type 1 Diabetes
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: Education
Participants in the Education group will complete a behavioral health contract and will receive an educational packet.
Behavioral: Education
Adolescents will complete a health behavior contract and receive an educational packet with information about diabetes management.

Experimental: PA + Education
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.
Behavioral: Check It
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.

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




Primary Outcome Measures :
  1. Glycemic Control (A1C) [ Time Frame: 3 months ]
    A1C is the percentage of glycosylated hemoglobin and represents an average of glycemic control


Secondary Outcome Measures :
  1. Diabetes Distress [ Time Frame: 3 months ]
    The Problem Area In Diabetes - Teen (PAID-T) will be used to measure diabetes distress. Scores range from 14-84, and a total score of 44 or higher is considered clinically significant.

  2. Primary Control Coping [ Time Frame: 3 months ]
    Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher scores indicate greater relative use of primary control coping (e.g., problem solving, emotional modulation).

  3. Secondary Control Coping [ Time Frame: 3 months ]
    Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher levels indicate greater relative use of secondary control coping (e.g., acceptance, distraction, positive thinking).

  4. Disengagement Coping [ Time Frame: 3 months ]
    Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher levels indicate greater relative use of disengagement coping (e.g., avoidance, denial).

  5. Positive Affect [ Time Frame: 3 months ]
    Positive affect measured using the Positive and Negative Affect Scale for children (PANAS-C). The positive affect scale consists of 15 items, which are summed for a total score, ranging from 15-60. Higher scores indicate higher levels of positive affect.

  6. Diabetes Self-Care Behavior [ Time Frame: 3 months ]
    The Self Care Inventory measures adherence to the recommended diabetes treatment regimen. Adolescents and parents report on the adolescents' self-care behaviors. Items are summed for a total score, ranging from 7-35. Higher scores indicate higher levels of adherence.

  7. Diabetes-Related Quality of Life [ Time Frame: 3 months ]
    Type 1 Diabetes and Life measures diabetes-related quality of life. Scores range from 0-100, and higher scores indicate better quality of life.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (score 44 or higher)

Exclusion Criteria:

- Other serious health conditions


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845465


Contacts
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Contact: Sarah Jaser, PhD 6153436775 sarah.jaser@vumc.org
Contact: Emily Hamburger, MEd 6158758781 emily.hamburger@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Children's Research Institute

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Responsible Party: Sarah Jaser, Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03845465     History of Changes
Other Study ID Numbers: 190020
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases