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

University of Valencia

Status: Unknown

Conditions: Diabetes type1

Treatments: Other: Psychological intervention (self-compassion based)

Study type: Interventional

Funder types: Other

Identifiers

NCT05437913

SWEET2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 12 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for the caregivers:

• 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.

Inclusion Criteria for the patients/teens:

• 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.

General 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).

Exclusion criteria for teens:

• untreated hypothyroidism
• recently (in previous 48 hours of the recruiting process) diagnosed with (a) diabetic ketoacidosis (DKA) or (b) severe hypoglycaemia.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Self compassion intervention

Other group

Description:

4 weeks group and online format self compassion intervention

Treatment:

Other: Psychological intervention (self-compassion based)