An interventional study of The BEM (Body Emotional Maps) program and Control group in Stress (Psychology) and Diabete Type 1, sponsored by Valentino Cherubini. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by Valentino Cherubini · Not applicable, Interventional, and Other
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.
990 studies on the registry are indexed under Chronic Disease; 178 are open to participants now.
This study's enrollment of 139 is above the median of 120 across 722 interventional studies indexed under Chronic Disease.
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Exclusion Criteria:
Parents:
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
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
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.
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.
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.
Time frame: From enrollment to 3 months after the participation in the BEM activities
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
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.
Time frame: from enrollment to 6 months from participation in the group activities compared to baseline
Patient Health Questionnaire (PHQ-9)
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.
Time frame: From enrollment to 3 and 6 months from participation in the group activities compared to baseline
General Anxiety Disorder (GAD-7)
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.
Time frame: From enrollment to 3 and 6 months from participation in the group activities compared to baseline.
Brief Pittsburgh Sleep Quality Index (B-PSQI)
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.
Time frame: 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.
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.
Time frame: From enrollment to 3 and 6 months from participation in the group activities compared to baseline
Coping Orientation to the Problems Experienced - Italian Version (COPE-NVI)
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.
Time frame: From enrollment to 3 and 6 months from participation in the group activities compared to baseline
Glucometric data of children/adolescents
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.
Time frame: From enrollment to 3 and 6 months from participation in the group activities compared to baseline.
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