Physical Activity in People With Borderline Personality Disorder (PABORD)

NCT06461104 | Not Yet Recruiting

• 1 other identifier: P1A1B2O3R5D8
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Does a structured PA program reduce clinical symptoms in patients with BPD?
2. 2.How does the effectiveness of a structured PA program compare to a psychoeducational intervention in reducing clinical symptoms and improving physical activity parameters?

Conditions

Borderline Personality Disorder

Keywords

Physical Activity; Borderline Personality Disorder; ESM; Females; Global Functioning; Accelerometer; Motivation; Premenstrual Syndrome; Outpatients

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Improvement of Physical Activity-Related Parameters

  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

  Baseline (start of the study), end of 3-months treatment (week 12), end of 3-months follow-up (week 24)

Study Arms (2)

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.

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.

Behavioral: Psychoeducational Programme

Interventions

Structured Physical Activity Programme BEHAVIORAL

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.

Also known as: Physical Activity

Intervention Group

Psychoeducational Programme BEHAVIORAL

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.

Also known as: Psychoeducation, Psychoeducation Intervention

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Centro San Giovanni di Dio Fatebenefratelli: lead

Study Sites (1)

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Brescia, 25125, Italy

Location

Related Publications (1)

• 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.

  PMID: 39415283 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder; Motor Activity; Premenstrual Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Behavior; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Giovanni de Girolamo, MD

  IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni de Girolamo, MD

CONTACT

030-3501590; gdegirolamo@fatebenefratelli.eu

Silvia Leone, PsyD

CONTACT

030-3501333; sleone@fatebenefratelli.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 14, 2024
• Study Start: September 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: April 1, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)