Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461104
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-05
Brief Title:
Physical Activity in People With Borderline Personality Disorder PABORD
Sponsor:
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Organization:
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Study Overview
Official Title:
Physical Activity in People With Borderline Personality Disorder PABORD a Study Protocol for a Pilot Randomised Controlled Trial RCT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PABORD
Brief 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 Does a structured PA program reduce clinical symptoms in patients with BPD
2 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
1 Does a structured PA program reduce clinical symptoms in patients with BPD
2 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 studys objectives procedures and the potential risks and benefits of the proposed treatments After confirming inclusionexclusion 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 n30 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 n30 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 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 studys objectives procedures and the potential risks and benefits of the proposed treatments After confirming inclusionexclusion 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 n30 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 n30 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None