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临床试验/NCT06699732
NCT06699732已完成不适用

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 University6 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年9月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
6
主要终点
World Health Organization Quality of Life Scale Urdu Version

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

盲法说明

Double

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Experimental

Experimental

Who receives intervention i.e. Mindful Self Compassion Therapy

干预措施: Mindful Self Compassion Therapy (Behavioral)

Waitlist Control

Active Comparator

Who would receive intervention after study completion

干预措施: Mindful Self Compassion Therapy (Behavioral)

结局指标

主要结局

World Health Organization Quality of Life Scale Urdu Version

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Asma Mansoor

Principal Investigator

Fatima Jinnah Women University

研究点 (6)

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