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Protocol for Self-Compassion Intervention for Teens With Diabetes Type 1 and Their Caregivers

Brief Self-Compassion Intervention for Adolescents With Diabetes Type 1 and Their Caregivers: Protocol for a Single Case Multiple-baseline Feasibility Study

NCT05437913•University of Valencia

View on ClinicalTrials.gov

Summary

The goal of this study is to examine the feasibility and potential effectiveness of a short (4 sessions) self-compassion intervention for adolescents with T1D and their caregivers on psychological, metabolic, and behavioral outcomes.

Detailed Description

Type 1 Diabetes (TD1) has a significant impact on individuals dealing with this chronic metabolic condition, their families and the whole society. A particularly vulnerable group of individuals with TD1 are adolescents. The investigators created a short (4 sessions) self-compassion intervention for adolescents with T1D and their caregivers. Both feasibility and potential clinical effectiveness will be assessed using a single-case, multiple baseline experimental design where psychological, behavioral, and metabolic outcomes will be evaluated at baseline, post intervention, and 3- and 6-months follow ups. Moreover, ecological momentary assessment will be performed daily.

Eligibility

Age

12 - 15 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•have taken care of the management of the patient with diabetes for at least one year since the day of recruitment
•they have access to a personal mobile phone.
•aged 11-15 years old
•diagnosed with T1D more than 12 months ago at the time of recruitment
•they have access to a personal mobile phone.

Exclusion Criteria

•non-Spanish native speakers
•presenting developmental or attention deficit disorders (e.g., autism spectrum disorder, ADHD)
•being diagnosed with a serious mental disorder requiring ongoing treatment (e.g., psychosis) or receiving a pharmacological intervention (e.g., depression, anxiety).
•untreated hypothyroidism
•recently (in previous 48 hours of the recruiting process) diagnosed with (a) diabetic ketoacidosis (DKA) or (b) severe hypoglycaemia.

Locations (1)

University of Valencia

Valencia, Spain

Key Dates

Start Date

September 6, 2021

Primary Completion Date

March 15, 2022

Completion Date

September 15, 2022

Last Updated

June 29, 2022

Enrollment

ACTUAL participants

Conditions

Diabetes type1

Interventions

Psychological intervention (self-compassion based)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Protocol for Self-Compassion Intervention for Teens With Diabetes Type 1 and Their Caregivers

Inclusion Criteria

Exclusion Criteria

Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes

Exploration of Health Literacy in Diabetes in Reunion Island and France

Pilot of Pragmatic Delivery of Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes

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