Stress (Psychology)BEM-02NCT07098689
Body Emotional Map Method for the Reduction of Parental Stress Related to Diabetes
A study testing The BEM (Body Emotional Maps) program in people with Stress (Psychology) and Diabete Type 1, run by Valentino Cherubini at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress (Psychology), Diabete Type 1
- What is being tested?
- The BEM (Body Emotional Maps) program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteItaly
- Study dates
- 11 Apr 2024to 12 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
Department of Women's and Children's Health Azienda Ospedaliero Universitaria delle Marche, G. Salesi Hospital
Ancona, 60123
About this study
Official title: Body Emotional Map Method for the Reduction of Parental Stress Related to Diabetes: a Randomized Study. BEM-02
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
- Being tested
- The BEM (Body Emotional Maps) program, Control group
- Keywords
- BODY EMOTIONAL MAP, PARENTAL STRESS, chronic condition, Type 1 diabetes
- Medical subject headings
- Chronic Disease, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The BEM (Body Emotional Maps) programOther
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to 3 and 6 months from participation in the group activities compared to baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start11 Apr 2024
- Primary completion15 Mar 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress (Psychology)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valentino Cherubini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Valentino Cherubini, Ospedali Riuniti Ancona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098689
- Sponsor's protocol ID
- 26072023
- Acronym
- BEM-02
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Emotional Map Method for the Reduction of Parental Stress Related to Diabetes: a Randomized Study. BEM-02
- ClinicalTrials.gov ID
- NCT07098689
- Acronym / sponsor ID
- BEM-02 / 26072023
- Conditions
- Stress (Psychology), Diabete Type 1
- Keywords
- BODY EMOTIONAL MAP, PARENTAL STRESS, chronic condition, Type 1 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Valentino CherubiniUniversity, hospital or other
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BEM group | Experimental | Other: The BEM (Body Emotional Maps) programIn 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). |
| Control group | Active comparator | Other: Control groupIn 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The BEM (Body Emotional Maps) programThe 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. | Other | BEM group |
| Control groupThe 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. | Other | Control group |
Primary outcome
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.
7 secondary outcomes
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
Patient Health Questionnaire (PHQ-9)
Time frame: From enrollment to 3 and 6 months from participation in the group activities compared to baseline
General Anxiety Disorder (GAD-7)
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)
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.
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)
Time frame: From enrollment to 3 and 6 months from participation in the group activities compared to baseline
Glucometric data of children/adolescents
Time frame: From enrollment to 3 and 6 months from participation in the group activities compared to baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The BEM (Body Emotional Maps) program in people with Stress (Psychology) and Diabete Type 1, run by Valentino Cherubini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.