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Completed

NCT Number: NCT07098689

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ancona, 60123, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: From enrollment to 3 months after the participation in the BEM activities

    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.

Secondary outcomes

  1. 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

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

    The secondary endpoint is represented by the difference in PSI-SF (Parental Stress Index Short-Form) scores (total and of each suscale) after 6 months of participation in the group activities compared to baseline. 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.

  2. Patient Health Questionnaire (PHQ-9)

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

    Difference in the scores of the Patient Health Questionnaire (PHQ-9) for the assessment of depression and depressive symptoms after 3 and 6 months from the baseline. Each symptom is rated on a 4-point scale. Scores range from 0 to 27, with different levels of depression severity depending on the score: 10-14 = Mild major depression; 15-19 = Moderate major depression; ≥ 20 = Severe major depression.

  3. General Anxiety Disorder (GAD-7)

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

    Difference in the scores of the General Anxiety Disorder (GAD-7) questionnaire for the assessment of anxiety and anxious symptoms. Scores of 0, 1, 2, or 3 are assigned for symptoms occurring "not at all," "several days," "more than half the days," and "almost every day," respectively. The scores are then summed and range from 0 to 21. Scores of 5, 10, and 15 represent cutoffs for mild, moderate, and severe anxiety, respectively.

  4. Brief Pittsburgh Sleep Quality Index (B-PSQI)

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

    Difference in the scores of the Brief Pittsburgh Sleep Quality Index (B-PSQI) for the assessment of sleep disturbances. For each area, a score from 0 (highest positive) to 3 (lowest negative) is assigned, as follows: "Never during the last month" = 0; "Less than once a week" = 1; "1 or 2 times a week" = 2; "3 or more times a week" = 3. Summary score is then generated, obtained by adding the scores for the individual areas, with a value ranging from 0 to 21. Score between 5 and 7 indicates mild sleep disturbances may occur; score above 7 indicates that it is recommended to consult a doctor for a more in-depth evaluation of sleep disturbances.

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

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

    Difference in the scores of the Parental Self-Efficacy for the Management of Diabetes Mellitus (PSESDM) questionnaire for the evaluation of self-efficacy perception in managing their child's diabetes. Responses range from 1 = "Strongly disagree" to 5 = "Strongly agree." Items 1, 2, 6, and 7 are reverse-scored. The total score on the measure ranges from 8 to 40. A higher score on the PSESDM represents greater parental confidence in managing their child's diabetes.

  6. Coping Orientation to the Problems Experienced - Italian Version (COPE-NVI)

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

    Difference in the scores of the Coping Orientation to the Problems Experienced - Italian Version (COPE-NVI) questionnaire for assessing parental adaptation and coping strategies. Responses to each question are given on a scale from 1 = "I usually don't do it" to 4 = "I almost always do it." Individual question scores are summed separately for each of the 5 areas.

  7. Glucometric data of children/adolescents

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

    Difference in glucometric data of children/adolescents:

    • HbA1c; if CGM, glucose values in the last 15 days:
    • Time in Range;
    • Time below range level 1;
    • Time below range level 2;
    • Time above range level 1;
    • Time above range level 2,
    • Average blood glucose.

Sponsors and collaborators

Lead sponsor

Valentino Cherubini

Other

Registry information

Official study title

Body Emotional Map Method for the Reduction of Parental Stress Related to Diabetes: a Randomized Study. BEM-02

Acronym: BEM-02

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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