Body Emotional Map Method for the Reduction of Parental Stress Related to Diabetes

NCT07098689 | Completed

• 1 other identifier: 26072023
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress (Psychology); Diabete Type 1

Keywords

BODY EMOTIONAL MAP; PARENTAL STRESS; chronic condition; Type 1 diabetes

Outcome Measures

Primary Outcomes (1)

• Difference in PSI-SF (Parental Stress Index Short-Form) scores after 3 months

  The primary endpoint is represented by the difference in PSI-SF (Parental Stress Index Short-Form) scores after 3 months of participation in the group activities compared to baseline. PSI-SF subscale scores range from 12 to 60, and the total score from 36 to 180. High subscale scores and a high PSI-SF total score indicate higher levels of stress. Responses above the 85th percentile are considered clinically significant.

  From enrollment to 3 months after the participation in the BEM activities

Secondary Outcomes (7)

• Difference in PSI-SF (Parental Stress Index Short-Form) scores after 6 months and in the scores of the individual components of the PSI-SF questionnaire

  from enrollment to 6 months from participation in the group activities compared to baseline

• Patient Health Questionnaire (PHQ-9)

  From enrollment to 3 and 6 months from participation in the group activities compared to baseline

• General Anxiety Disorder (GAD-7)

  From enrollment to 3 and 6 months from participation in the group activities compared to baseline.

• Brief Pittsburgh Sleep Quality Index (B-PSQI)

  From enrollment to 3 and 6 months from participation in the group activities compared to baseline

• Parental Self-Efficacy for the Management of Diabetes Mellitus (PSESDM) questionnaire.

  From enrollment to 3 and 6 months from participation in the group activities compared to baseline

Study Arms (2)

BEM group

EXPERIMENTAL

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).

Other: The BEM (Body Emotional Maps) program

Control group

ACTIVE COMPARATOR

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).

Other: Control group

Interventions

The BEM (Body Emotional Maps) program OTHER

The BEM method involves an intervention with the parents of children with diabetes, conducted in group settings, aimed at facilitating parents' adaptation to their child's "diabetes condition". The BEM method involves an intervention with the parents of children with diabetes, conducted in group settings, aimed at facilitating parents' adaptation to their child's "diabetes condition". The intervention is organized into three sessions. The first session consists of an introduction and group formation. The second session involves sharing the onset of diabetes, identifying the most critical daily challenges, and the primary change the participants wish to implement. The third session features the BEM pathway, which includes guided visualization and the creation of a map with spatial anchors.

BEM group

Control group OTHER

The control group will receive the same diabetes management information, accompanied by parent discussion sessions and recreational activities guided by the diabetes team staff. As with the BEM group, activities will take place over three days in an off-hospital location, in contact with nature.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Valentino Cherubini: lead

Study Sites (1)

Department of Women's and Children's Health Azienda Ospedaliero Universitaria delle Marche, G. Salesi Hospital

Ancona, 60123, Italy

Location

MeSH Terms

Conditions

Chronic Disease; Diabetes Mellitus, Type 1

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Unit, Paediatric Diabetology Department of Women's and Children's Health "G. Salesi Hospital", AOU OORR Ancona, Via F. Corridoni, 11 60123 Ancona, Italy

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 1, 2025
• Study Start: April 11, 2024
• Primary Completion: March 15, 2025
• Study Completion: June 12, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)