Borderline Personality DisorderPABORDNCT06461104
Physical Activity in People With Borderline Personality Disorder (PABORD)
A study testing Structured Physical Activity Programme and Psychoeducational Programme in people with Borderline Personality Disorder, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
Trial summary
The aim of this Randomised Controlled Trial (RCT) is to test the effects of a structured physical activity (PA) program on symptoms in female outpatients aged 18 to 40 years with a diagnosis of Borderline Personality Disorder (BPD). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Structured Physical Activity Programme and Psychoeducational Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2024to 1 Apr 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female gender.
- Age between 18 and 40 years.
- Primary diagnosis of Borderline Personality Disorder (BPD) according to the diagnostic criteria of the DSM-5.
- Outpatient treatment.
- Ability to provide written informed consent.
- Good understanding of the Italian language.
- Proficiency in using a smartphone.
- The presence of ongoing pharmacological and/or psychotherapeutic treatments is not considered an exclusion criterion.
Who cannot join
- Current pregnancy or planning a pregnancy within the next 6 months.
- Acute psychotic symptoms.
- Comorbidities with Eating Disorders, Substance Use Disorder, and Bipolar Disorder.
- Absolute contraindications to physical exercise, such as medical conditions that interfere with the ability to perform exercise or with the physiological response to exercise tests, e.g., the use of beta-adrenergic blocking agents.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, 25125
Giovanni de Girolamo, MD, 030 3501590 ext. 0039, gdegirolamo@fatebenefratelli.eu
Giovanni de Girolamo, MD
About this study
Official title: Physical Activity in People With Borderline Personality Disorder (PABORD): a Study Protocol for a Pilot Randomised Controlled Trial (RCT)
The aim of this Randomised Controlled Trial (RCT) is to test the effects of a structured physical activity (PA) program on symptoms in female outpatients aged 18 to 40 years with a diagnosis of Borderline Personality Disorder (BPD). The main questions it aims to answer are:
- Does a structured PA program reduce clinical symptoms in patients with BPD?
- How does the effectiveness of a structured PA program compare to a psychoeducational intervention in reducing clinical symptoms and improving physical activity parameters?
Read more
Participants will participate in a 12-week structured PA program preceded by three weekly psychoeducation sessions focused on nutrition (intervention group) or will receive a 12-week psychoeducational program on nutrition and PA (control group).
Researchers will compare the intervention group (structured PA program) and the control group (psychoeducational program) to see if the structured PA program leads to greater improvements in clinical symptoms and physical activity parameters. Moreover, the study includes a multidimensional assessment (physical, psychological, and biological) at four time points: at the start of the treatment (T0), at 6 weeks (mid-treatment, when changes from PA become visible and measurable), at the end of the 3-month treatment period (T3), and at a 3-month follow-up after the treatment (T6).
Read the detailed description
Background and Objectives This randomised controlled trial (RCT) aims to investigate the effects of a structured physical activity (PA) programme on the symptoms of outpatients who meet DSM-5-TR criteria for Borderline Personality Disorder (BPD). The hypothesis is that these symptoms may improve over the course of the PA treatment. The primary objective is to evaluate the efficacy of a structured PA intervention on reducing clinical symptoms and improving PA-related parameters compared to a psychoeducational intervention on healthy lifestyle.
Study Design The PABORD RCT is a controlled study involving female outpatients aged 18 to 40 years with a BPD diagnosis. Participants will be informed about the study's objectives, procedures, and the potential risks and benefits of the proposed treatments. After confirming inclusion/exclusion criteria, obtaining signed informed consent, and reviewing the data processing information, participants will be randomly assigned to two groups. This trial will be conducted in accordance with the Declaration of Helsinki (World Medical Association, 2013).
Treatment Arms
The study involves two treatment arms:
Intervention Group (n=30): Participants will engage in a 12-week structured PA programme, preceded by three weekly psychoeducational sessions focused on nutrition. This includes three 60-minute PA sessions per week supervised by a personal trainer.
Control Group (n=30): Participants will receive a 12-week psychoeducational programme on nutrition and PA. This programme includes 8 sessions divided into modules of 2 or 3 lessons each, covering topics such as the benefits of PA and sports, healthy eating habits, and health risks associated with a sedentary lifestyle. Sessions will be conducted by a dietitian and a clinical psychologist. At the end of the trial, control group participants will be offered the opportunity to participate in the same PA programme as the intervention group at no cost.
Assessment and Follow-Up
The study includes a multidimensional assessment (physical, psychological, and biological) at four time points: T0 (baseline), 6 weeks (mid-treatment), T3 (end of treatment), and T6 (3-month follow-up). These assessments will include:
- Standardised tests for BPD symptoms and general functioning.
- Physical examinations by a sports physician to create a personalised PA plan and assess health status post-intervention.
- Evaluation of premenstrual syndrome (PMS) and obstetric history to determine potential improvements related to PA.
- Use of an accelerometer for 7 days to monitor movement and sleep-wake patterns, and an app using the Experience Sampling Method (ESM) for real-time mood and psychosocial dimension assessments.
- Use of an app for dietary tracking.
- Blood and saliva sample analysis to detect PA-induced changes at the biological level.
The follow-up aims to determine whether the structured PA intervention results in medium-term improvements in BPD symptoms, sustained PA levels, changes in motivation for PA, and alterations in PMS symptoms. This will be assessed through accelerometer data, ESM mood and social interaction reports, and analysis of selected biomarkers in blood and saliva.
- Conditions
- Borderline Personality Disorder
- Being tested
- Structured Physical Activity Programme, Psychoeducational Programme
- Keywords
- Physical Activity, Borderline Personality Disorder, ESM, Females, Global Functioning, Accelerometer, Motivation, Premenstrual Syndrome, Outpatients
- Medical subject headings
- Borderline Personality Disorder, Motor Activity, Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Physical Activity ProgrammeBehavioural
Also called Physical Activity
A somatic examination will also be conducted by a sports physician, which will include the assessment of muscle strength, cardiorespiratory fitness, walking gait, blood pressure, and body mass index (BMI). Based on this evaluation, the sports physician will design a personalised physical activity programme for the participants in the intervention group.
Psychoeducational ProgrammeBehavioural
Also called Psychoeducation, Psychoeducation Intervention
The control group undergoes a 12-week psychoeducational programme on nutrition and PA, consisting of 8 sessions. Led by a dietitian and psychologist, topics include PA benefits, healthy eating, and sedentary lifestyle risks. The experimental group receives 3 sessions on dietary habits before starting PA intervention, ensuring differentiation. It's expected the experimental group directly benefits from exercise, while the control group benefits from PA education. At the trial's end, control group members can join the PA programme for free.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will engage in a 12-week structured PA programme, preceded by three weekly psychoeducational sessions focused on nutrition. This includes three 60-minute PA sessions per week supervised by a personal trainer. Receives: Behavioral: Structured Physical Activity Programme; Behavioral: Psychoeducational Programme |
| Control Group | Active comparator | Participants will receive a 12-week psychoeducational programme on nutrition and PA. This programme includes 8 sessions divided into modules of 2 or 3 lessons each, covering topics such as the benefits of PA and sports, healthy eating habits, and health risks associated with a sedentary lifestyle. Sessions will be conducted by a dietitian and a clinical psychologist. At the end of the trial, control group participants will be offered the opportunity to participate in the same PA programme as the intervention group at no cost. Receives: Behavioral: Psychoeducational Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Borderline Personality Disorder Symptomatology
The Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) scale measures borderline personality symptomatology. A reduction in score of at least 3.5 indicates improvement, as demonstrated in previous pharmacological treatment studies. Administered at baseline, end of treatment (T3), and end of follow-up (T6) to assess the impact of structured PA treatment on DBP symptomatology. Evaluators blinded to group assignment will obtain and examine outcome measurements.
Measured: Baseline (start of the study), end of 3-months treatment (week 12), end of 3-months follow-up (week 24)
Improvement of BPD-Related Symptomatology
Additional primary outcomes include psychological variables associated with BPD, including sleep hygiene, mood changes, anxiety, impulsivity, and disability impact on daily functioning. Assessment tools include the Experience Sampling Method (ESM), Beck Depression Inventory short form (BDI-13), State-Trait Anxiety Inventory (STAI-Y), Impulsive Behavior Scale (UPPS-P), World Health Organization Disability Assessment Schedule (WHODAS 2.0), and Premenstrual Symptom Screening Tool (PSST). ESM utilizes a custom app for real-time evaluation, while other tools are self-reported questionnaires administered at different time points throughout the study.
Measured: Baseline (start of the study), end of 3-months treatment (week 12), end of 3-months follow-up (week 24)
Secondary outcomes (2)
Improvement of Physical Activity-Related Parameters
The secondary outcomes aim to measure increased physical activity (PA) intensity and quantity using actigraphic, dynamometric measures, and questionnaires at various intervals. Expected physical health improvements include enhanced muscle strength, cardiorespiratory fitness, blood pressure, and BMI. Biological markers such as BDNF, kynurenine, cortisol, and DHEA, as well as specific biomarkers like agrin and Nf-L, will be analyzed post-PA intervention. Additional assessments cover innovative biomarkers, resting blood glucose, and basic hematological analyses. Motivation and self-regulation will be assessed using validated Italian versions of BREQ-3, P-scale, and RSES.
Measured: Baseline (start of the study), week 6 (half of the 3-months treatment), end of 3-months treatment (week 12), end of 3-months follow-up (week 24)
Reduction of Premenstrual Symptom Exacerbation
The presence, severity, and changes in premenstrual symptoms will be assessed using the Premenstrual Symptom Screening Tool (PSST) questionnaire.
Measured: Baseline (start of the study), end of 3-months treatment (week 12), end of 3-months follow-up (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomised controlled trial (RCT) is designed to evaluate the efficacy of a structured physical activity (PA) programme compared to a psychoeducational intervention on healthy lifestyle in female outpatients aged 18 to 40 years with a diagnosis of Borderline Personality Disorder (BPD). Participants will be randomly assigned to one of two groups: an intervention group that engages in a 12-week structured PA programme preceded by three psychoeducational sessions focused on nutrition, and a control group that receives a 12-week psychoeducational programme on nutrition and PA. The study aims to assess changes in clinical symptoms, PA-related parameters, and various physical, psychological, and biological outcomes at baseline, mid-treatment, end of treatment, and at a 3-month follow-up. This RCT adheres to the Declaration of Helsinki and involves comprehensive informed consent and data processing protocols.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni de Girolamo, MD, Principal investigator, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461104
- Sponsor's protocol ID
- P1A1B2O3R5D8
- Acronym
- PABORD
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Girolamo G, Leone S, D'Addazio M, Toffol E, Martinelli A, Bellini S, Calza S, Carnevale M, Cattane N, Cattaneo A, Ghidoni R, Longobardi A, Maffezzoni D, Martella D, Meloni S, Mombelli E, Pogliaghi S, Saraceno C, Tura GB, Rossi R. Physical Activity in young female outpatients with BORderline personality Disorder (PABORD): a study protocol for a randomized controlled trial (RCT). Trials. 2024 Oct 16;25(1):685. doi: 10.1186/s13063-024-08525-8.
PubMed 39415283
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity in People With Borderline Personality Disorder (PABORD): a Study Protocol for a Pilot Randomised Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT06461104
- Acronym / sponsor ID
- PABORD / P1A1B2O3R5D8
- Conditions
- Borderline Personality Disorder
- Keywords
- Physical Activity, Borderline Personality Disorder, ESM, Females, Global Functioning, Accelerometer, Motivation, Premenstrual Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 14 Jun 2024 (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 aim of this Randomised Controlled Trial (RCT) is to test the effects of a structured physical activity (PA) program on symptoms in female outpatients aged 18 to 40 years with a diagnosis of Borderline Personality Disorder (BPD). The main questions it aims to answer are:
- Does a structured PA program reduce clinical symptoms in patients with BPD?
- How does the effectiveness of a structured PA program compare to a psychoeducational intervention in reducing clinical symptoms and improving physical activity parameters?
Participants will participate in a 12-week structured PA program preceded by three weekly psychoeducation sessions focused on nutrition (intervention group) or will receive a 12-week psychoeducational program on nutrition and PA (control group).
Researchers will compare the intervention group (structured PA program) and the control group (psychoeducational program) to see if the structured PA program leads to greater improvements in clinical symptoms and physical activity parameters. Moreover, the study includes a multidimensional assessment (physical, psychological, and biological) at four time points: at the start of the treatment (T0), at 6 weeks (mid-treatment, when changes from PA become visible and measurable), at the end of the 3-month treatment period (T3), and at a 3-month follow-up after the treatment (T6).
Detailed description
Background and Objectives This randomised controlled trial (RCT) aims to investigate the effects of a structured physical activity (PA) programme on the symptoms of outpatients who meet DSM-5-TR criteria for Borderline Personality Disorder (BPD). The hypothesis is that these symptoms may improve over the course of the PA treatment. The primary objective is to evaluate the efficacy of a structured PA intervention on reducing clinical symptoms and improving PA-related parameters compared to a psychoeducational intervention on healthy lifestyle.
Study Design The PABORD RCT is a controlled study involving female outpatients aged 18 to 40 years with a BPD diagnosis. Participants will be informed about the study's objectives, procedures, and the potential risks and benefits of the proposed treatments. After confirming inclusion/exclusion criteria, obtaining signed informed consent, and reviewing the data processing information, participants will be randomly assigned to two groups. This trial will be conducted in accordance with the Declaration of Helsinki (World Medical Association, 2013).
Treatment Arms
The study involves two treatment arms:
Intervention Group (n=30): Participants will engage in a 12-week structured PA programme, preceded by three weekly psychoeducational sessions focused on nutrition. This includes three 60-minute PA sessions per week supervised by a personal trainer.
Control Group (n=30): Participants will receive a 12-week psychoeducational programme on nutrition and PA. This programme includes 8 sessions divided into modules of 2 or 3 lessons each, covering topics such as the benefits of PA and sports, healthy eating habits, and health risks associated with a sedentary lifestyle. Sessions will be conducted by a dietitian and a clinical psychologist. At the end of the trial, control group participants will be offered the opportunity to participate in the same PA programme as the intervention group at no cost.
Assessment and Follow-Up
The study includes a multidimensional assessment (physical, psychological, and biological) at four time points: T0 (baseline), 6 weeks (mid-treatment), T3 (end of treatment), and T6 (3-month follow-up). These assessments will include:
- Standardised tests for BPD symptoms and general functioning.
- Physical examinations by a sports physician to create a personalised PA plan and assess health status post-intervention.
- Evaluation of premenstrual syndrome (PMS) and obstetric history to determine potential improvements related to PA.
- Use of an accelerometer for 7 days to monitor movement and sleep-wake patterns, and an app using the Experience Sampling Method (ESM) for real-time mood and psychosocial dimension assessments.
- Use of an app for dietary tracking.
- Blood and saliva sample analysis to detect PA-induced changes at the biological level.
The follow-up aims to determine whether the structured PA intervention results in medium-term improvements in BPD symptoms, sustained PA levels, changes in motivation for PA, and alterations in PMS symptoms. This will be assessed through accelerometer data, ESM mood and social interaction reports, and analysis of selected biomarkers in blood and saliva.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This randomised controlled trial (RCT) is designed to evaluate the efficacy of a structured physical activity (PA) programme compared to a psychoeducational intervention on healthy lifestyle in female outpatients aged 18 to 40 years with a diagnosis of Borderline Personality Disorder (BPD). Participants will be randomly assigned to one of two groups: an intervention group that engages in a 12-week structured PA programme preceded by three psychoeducational sessions focused on nutrition, and a control group that receives a 12-week psychoeducational programme on nutrition and PA. The study aims to assess changes in clinical symptoms, PA-related parameters, and various physical, psychological, and biological outcomes at baseline, mid-treatment, end of treatment, and at a 3-month follow-up. This RCT adheres to the Declaration of Helsinki and involves comprehensive informed consent and data processing protocols.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Structured Physical Activity Programme, Behavioral: Psychoeducational ProgrammeParticipants will engage in a 12-week structured PA programme, preceded by three weekly psychoeducational sessions focused on nutrition. This includes three 60-minute PA sessions per week supervised by a personal trainer. |
| Control Group | Active comparator | Behavioral: Psychoeducational ProgrammeParticipants will receive a 12-week psychoeducational programme on nutrition and PA. This programme includes 8 sessions divided into modules of 2 or 3 lessons each, covering topics such as the benefits of PA and sports, healthy eating habits, and health risks associated with a sedentary lifestyle. Sessions will be conducted by a dietitian and a clinical psychologist. At the end of the trial, control group participants will be offered the opportunity to participate in the same PA programme as the intervention group at no cost. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female gender.
- Age between 18 and 40 years.
- Primary diagnosis of Borderline Personality Disorder (BPD) according to the diagnostic criteria of the DSM-5.
- Outpatient treatment.
- Ability to provide written informed consent.
Key exclusion criteria (4 listed)
- Current pregnancy or planning a pregnancy within the next 6 months.
- Acute psychotic symptoms.
- Comorbidities with Eating Disorders, Substance Use Disorder, and Bipolar Disorder.
- Absolute contraindications to physical exercise, such as medical conditions that interfere with the ability to perform exercise or with the physiological response to exercise tests, e.g., the use of beta-adrenergic blocking agents.
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 |
|---|---|---|
| Structured Physical Activity ProgrammeAlso: Physical ActivityA somatic examination will also be conducted by a sports physician, which will include the assessment of muscle strength, cardiorespiratory fitness, walking gait, blood pressure, and body mass index (BMI). Based on this evaluation, the sports physician will design a personalised physical activity programme for the participants in the intervention group. | Behavioural | Intervention Group |
| Psychoeducational ProgrammeAlso: Psychoeducation, Psychoeducation InterventionThe control group undergoes a 12-week psychoeducational programme on nutrition and PA, consisting of 8 sessions. Led by a dietitian and psychologist, topics include PA benefits, healthy eating, and sedentary lifestyle risks. The experimental group receives 3 sessions on dietary habits before starting PA intervention, ensuring differentiation. It's expected the experimental group directly benefits from exercise, while the control group benefits from PA education. At the trial's end, control group members can join the PA programme for free. | Behavioural | Control Group, Intervention Group |
Primary outcome
Reduction in Borderline Personality Disorder Symptomatology
Time frame: Baseline (start of the study), end of 3-months treatment (week 12), end of 3-months follow-up (week 24)
The Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) scale measures borderline personality symptomatology. A reduction in score of at least 3.5 indicates improvement, as demonstrated in previous pharmacological treatment studies. Administered at baseline, end of treatment (T3), and end of follow-up (T6) to assess the impact of structured PA treatment on DBP symptomatology. Evaluators blinded to group assignment will obtain and examine outcome measurements.
Improvement of BPD-Related Symptomatology
Time frame: Baseline (start of the study), end of 3-months treatment (week 12), end of 3-months follow-up (week 24)
Additional primary outcomes include psychological variables associated with BPD, including sleep hygiene, mood changes, anxiety, impulsivity, and disability impact on daily functioning. Assessment tools include the Experience Sampling Method (ESM), Beck Depression Inventory short form (BDI-13), State-Trait Anxiety Inventory (STAI-Y), Impulsive Behavior Scale (UPPS-P), World Health Organization Disability Assessment Schedule (WHODAS 2.0), and Premenstrual Symptom Screening Tool (PSST). ESM utilizes a custom app for real-time evaluation, while other tools are self-reported questionnaires administered at different time points throughout the study.
2 secondary outcomes
Improvement of Physical Activity-Related Parameters
Time frame: Baseline (start of the study), week 6 (half of the 3-months treatment), end of 3-months treatment (week 12), end of 3-months follow-up (week 24)
Reduction of Premenstrual Symptom Exacerbation
Time frame: Baseline (start of the study), end of 3-months treatment (week 12), end of 3-months follow-up (week 24)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Derived from this study: PubMed 39415283de Girolamo G, Leone S, D'Addazio M, Toffol E, Martinelli A, Bellini S, Calza S, Carnevale M, Cattane N, Cattaneo A, Ghidoni R, Longobardi A, Maffezzoni D, Martella D, Meloni S, Mombelli E, Pogliaghi S, Saraceno C, Tura GB, Rossi R. Physical Activity in young female outpatients with BORderline personality Disorder (PABORD): a study protocol for a randomized controlled trial (RCT). Trials. 2024 Oct 16;25(1):685. doi: 10.1186/s13063-024-08525-8.
- 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.
Giovanni de Girolamo, MD principal investigator
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Physical Activity Programme and Psychoeducational Programme in people with Borderline Personality Disorder, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli 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 8 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: status not confirmed, as of the sponsor's last update on 14 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giovanni de Girolamo, MD (030-3501590 ext. 0039, gdegirolamo@fatebenefratelli.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Borderline Personality Disorder Symptomatology (time frame: Baseline (start of the study), end of 3-months treatment (week 12), end of 3-months follow-up (week 24)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06461104, which also lists 1 linked publication.
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 14 Jun 2024.