Psychological DistressNCT06699732
Impact of Mindful Self-Compassion Therapy on Self Harm Behaviors, Emotional Regulation and Quality of Life Among Patients With Borderline Personality Disorder
A study testing Mindful Self Compassion Therapy in people with Psychological Distress and Emotional Regulation, run by Fatima Jinnah Women University at 2 sites in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Distress, Emotional Regulation, Self Harm
- What is being tested?
- Mindful Self Compassion Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesPakistan
- Study dates
- 21 Sep 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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) 4. Borderline personality patients who would be able to understand Urdu language and can give the informed consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Commandant Afimh
Rawalpindi, Punjab Province, 46000
Farid Family Hospital
Rawalpindi, Punjab Province, 46000
About this study
Official title: 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
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
Read the 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.
- Conditions
- Psychological Distress, Emotional Regulation, Self Harm, Quality of Life (QOL), Borderline Personality Disorder (BPD)
- Being tested
- Mindful Self Compassion Therapy
- Medical subject headings
- Emotional Regulation, Self-Injurious Behavior, Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Self Compassion TherapyBehavioural
Mindful Self-Compassion (MSC) therapy is an 8-week program blending mindfulness and self-compassion to improve emotional resilience and well-being.
Week 1: Introduction - Learn the basics of mindfulness, self-compassion, and reframing self-critical thoughts with kindness.
Week 2: Mindfulness - Practice observing thoughts and emotions without judgment to build self-awareness.
Week 3: Self-Kindness - Develop skills to treat yourself with warmth and care during difficult times.
Week 4: Common Humanity - Explore shared human experiences to reduce feelings of isolation.
Week 5: Working with Challenges - Learn strategies to respond compassionately to emotional pain.
Week 6: Growing Compassion - Deepen compassion for yourself and others through guided exercises.
Week 7: Resilience Building - Strengthen coping skills and foster emotional flexibility.
Week 8: Integration - Consolidate skills to maintain self-compassion in daily life.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Who receives intervention i.e. Mindful Self Compassion Therapy Receives: Behavioral: Mindful Self Compassion Therapy |
| Waitlist Control | Active comparator | Who would receive intervention after study completion Receives: Behavioral: Mindful Self Compassion Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization Quality of Life Scale Urdu Version
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start21 Sep 2024
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Women University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asma Mansoor, Fatima Jinnah Women University
- Investigators
- Asma Mansoor, PhD Scholar, Principal investigator, Fatima Jinnah Women University, Rawalpindi, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699732
- Sponsor's protocol ID
- FJWU/EC/2024/94
- Status last verified
- Aug 2026
- First submitted
- 19 Nov 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical concerns the data will not be shared. All research findings will be published in aggregate form maintaining patient anonymity
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06699732
- Acronym / sponsor ID
- FJWU/EC/2024/94
- Conditions
- Psychological Distress, Emotional Regulation, Self Harm, Quality of Life (QOL), Borderline Personality Disorder (BPD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fatima Jinnah Women UniversityUniversity, hospital or other
- Study start
- 21 Sep 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Mindful Self Compassion TherapyWho receives intervention i.e. Mindful Self Compassion Therapy |
| Waitlist Control | Active comparator | Behavioral: Mindful Self Compassion TherapyWho would receive intervention after study completion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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) 4. Borderline personality patients who would be able to understand Urdu language and can give the informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful Self Compassion TherapyMindful Self-Compassion (MSC) therapy is an 8-week program blending mindfulness and self-compassion to improve emotional resilience and well-being. Week 1: Introduction - Learn the basics of mindfulness, self-compassion, and reframing self-critical thoughts with kindness. Week 2: Mindfulness - Practice observing thoughts and emotions without judgment to build self-awareness. Week 3: Self-Kindness - Develop skills to treat yourself with warmth and care during difficult times. Week 4: Common Humanity - Explore shared human experiences to reduce feelings of isolation. Week 5: Working with Challenges - Learn strategies to respond compassionately to emotional pain. Week 6: Growing Compassion - Deepen compassion for yourself and others through guided exercises. Week 7: Resilience Building - Strengthen coping skills and foster emotional flexibility. Week 8: Integration - Consolidate skills to maintain self-compassion in daily life. | Behavioural | Experimental, Waitlist Control |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Due to ethical concerns the data will not be shared. All research findings will be published in aggregate form maintaining patient anonymity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asma Mansoor, PhD Scholar principal investigator
Fatima Jinnah Women University, Rawalpindi, Pakistan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Self Compassion Therapy in people with Psychological Distress and Emotional Regulation, run by Fatima Jinnah Women University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization Quality of Life Scale Urdu Version (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.