Body Emotional Map Method for the Reduction of Parental Stress Related to Diabetes (BEM-02)

Valentino Cherubini

Status: Completed

Conditions: Stress (Psychology); Diabete Type 1

Treatments: Other: The BEM (Body Emotional Maps) program; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT07098689

26072023

Details and patient eligibility

About

The purpose of this study is to evaluate the impact of the BEM method on stress and well-being in parents of children/adolescents with type 1 diabetes, compared to a standard group approach focused on therapeutic education (control group). The BEM Program involves an experiential, group-based approach facilitated by 2-3 trained facilitators and a maximum of 25 parent participants. Each session takes place over three consecutive days and includes both plenary sessions with the entire group and smaller subgroup activities. Metodology of BEM approach includes: relaxation techniques, breathing exercises, and guided visualizations NLP (Neuro-Linguistic Programming) techniques: spatial anchoring, Time Line therapy, and future pacing. Approaches based on Transactional Analysis (T.A.) and Systemic-Relational frameworks, brief interventions focused on problem-solving. Techniques for enhancing bodily and emotional awareness. Interactive group discussions. The control intervention will take place during a camp specifically dedicated to parents, with the same duration as the BEM program. The intervention includes educational and informational sessions on key aspects of type 1 diabetes management (management of acute complications, importance of glycemic indices, carbohydrate counting, current and emerging perspectives in type 1 diabetes care). In addition, the program includes opportunities for parents to share personal experiences and participate in recreational activities.

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Parents of children and adolescents under 18 years of age with type 1 diabetes duration exceeding 12 months;
• Parents of children who have never been diagnosed with psychiatric or behavioral disorders;
• Adequate understanding of the Italian language, as assessed by the clinician;
• Parents willing to: Actively participate in group experiential activities; Complete the required questionnaires; Signed informed consent from the participating individual; Signed informed consent for data processing of the minor by both parents (if applicable).

Exclusion criteria

Parents:

• with psychiatric conditions
• of patients with psychiatric issues or behavioral disorders
• with any problem that, according to the clinician's judgment, would prevent active participation in group experiential activities

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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139 participants in 2 patient groups

BEM group

Experimental group

Description:

In the BEM group, participants will receive basic information on diabetes management through external resources (medical support, technology, telemedicine, carbohydrate counting techniques) and internal resources (learning effective techniques and behaviors to improve metabolic control).

Treatment:

Other: The BEM (Body Emotional Maps) program

Control group

Active Comparator group

Description:

In the control group, basic information on diabetes management will be provided through external resources (medical support, technology, telemedicine, carbohydrate counting techniques) and internal resources (learning effective techniques and behaviors to improve metabolic control).

Treatment:

Other: Control group