- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03845465
Positive Psychology Intervention to Treat Diabetes Distress in Teens With Type 1 Diabetes (T1D)
September 26, 2023 updated by: Sarah Jaser, Vanderbilt University Medical Center
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
396
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- Children's National
-
-
Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Education
Participants in the Education group will complete a behavioral health contract and will receive an educational packet.
|
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.
|
Adolescents will complete a health behavior contract and receive an educational packet with information about diabetes management.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycemic Control (HbA1c)
Time Frame: 3 months
|
HbA1c is the percentage of glycosylated hemoglobin and represents an average of glycemic control
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
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 months
|
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).
|
3 months
|
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.
|
3 months
|
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).
|
3 months
|
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.
|
3 months
|
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.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 17, 2019
Primary Completion (Actual)
August 23, 2023
Study Completion (Actual)
September 7, 2023
Study Registration Dates
First Submitted
February 15, 2019
First Submitted That Met QC Criteria
February 18, 2019
First Posted (Actual)
February 19, 2019
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 26, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 190020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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