Physical Activity in People With Borderline Personality Disorder (PABORD)
NCT Number: NCT06461104
Acronym: PABORD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Borderline Personality Disorder
Interventions: BEHAVIORAL: Structured Physical Activity Programme|BEHAVIORAL: Psychoeducational Programme
Sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
Sex: FEMALE
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-04-01
Locations: IRCCS Centro San Giovanni di Dio Fatebenefratelli, Brescia, 25125, Italy

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).

Primary Outcome Measures: 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., 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., Baseline (start of the study), end of 3-months treatment (week 12), end of 3-months follow-up (week 24)
Secondary Outcome Measures: 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., 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., Baseline (start of the study), end of 3-months treatment (week 12), end of 3-months follow-up (week 24)