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Clinical Trials/NCT06699732
NCT06699732
Recruiting
Not Applicable

Impact of Mindful Self-Compassion Therapy on Self Harm Behaviors, Emotional Regulation and Quality of Life Among Patients With Borderline Personality Disorder: A Randomized Controlled Trial

Fatima Jinnah Women University2 sites in 1 country60 target enrollmentSeptember 21, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychological Distress
Sponsor
Fatima Jinnah Women University
Enrollment
60
Locations
2
Primary Endpoint
World Health Organization Quality of Life Scale Urdu Version
Status
Recruiting
Last Updated
8 months ago

Overview

Brief Summary

The primary purpose of the study is to investigate whether Mindful Self-Compassion (MSC) therapy can significantly reduce self-harm behaviors, improve emotional regulation, and enhance the quality of life in individuals diagnosed with Borderline Personality Disorder (BPD). The study aims to contribute to the existing literature by providing robust evidence on the efficacy of MSC therapy for BPD, which could inform clinical practices and improve treatment outcomes

Detailed Description

The current quantitative study will be carried out in two phases. A cross-sectional survey will assess quality of life, emotional regulation, psychological distress, self-harm behaviors, social support, and state of mindfulness during the first phase. A randomized controlled trial (RCT) will be done during the second phase where patients with Borderline Personality Disorder who are identified with psychological distress, low level of social support, and quality of life, will be categorized into two groups i.e. waitlist control group and intervention group through the process of randomization. Then Mindful Self Compassion therapy would be applied to participants in the intervention group. The control group is the waitlist control group so initially no intervention will be given to participants in the control group but the intervention will be given to the control group participants once the study is completed. The Mindful Self Compassion therapy would be implemented on participants using individual and in-person modes. The pre-and post-assessment will be done at Times 1 and 2 within and between control and interventional groups. After doing post-assessment the difference between pre and post-assessment will be compared to explore the efficacy of Mindful Self Compassion Therapy in patients with borderline personality.

Registry
clinicaltrials.gov
Start Date
September 21, 2024
End Date
December 30, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Asma Mansoor

Principal Investigator

Fatima Jinnah Women University

Eligibility Criteria

Inclusion Criteria

  • 1\. First time diagnosed non-hospitalized patients of Borderline Personality Disorder.
  • 2\. Patients of Borderline Personality Disorder experiencing psychological distress,low level of quality of life, social support, emotional dysregulation would be included.
  • 3\. Borderline Personality Disorder patients with age 18 years and above (both gender) from outpatient department (OPD)
  • Borderline personality patients who would be able to understand Urdu language and can give the informed consent
  • Exclusion criteria
  • The study would have the following exclusion criteria:
  • Hospitalized patients of Borderline Personality
  • Patients with Borderline Personality having other chronic co-morbid diseases such as cancer, cognitive deficits, and other chronic psychological disorders.
  • Patients with Borderline Personality younger than 18 years of age

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

World Health Organization Quality of Life Scale Urdu Version

Time Frame: 3 months

It has 26 items and four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains quality of life and general health items. The minimum value is 26 and the maximum value is 130. Higher scores on the scale indicate higher quality of life and low scores indicate low quality of life.

Study Sites (2)

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