Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-01-01 @ 8:42 AM
Study NCT ID:
NCT06699732
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2024-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Mindful Self-Compassion Therapy on Self Harm Behaviors, Emotional Regulation and Quality of Life Among Patients With Borderline Personality Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080103', 'term': 'Emotional Regulation'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001883', 'term': 'Borderline Personality Disorder'}], 'ancestors': [{'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2024-11-19', 'studyFirstSubmitQcDate': '2024-11-19', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'World Health Organization Quality of Life Scale Urdu Version', 'timeFrame': '3 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychological Distress', 'Emotional Regulation', 'Self Harm', 'Quality of Life (QOL)', 'Borderline Personality Disorder (BPD)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0248409', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. First time diagnosed non-hospitalized patients of Borderline Personality Disorder.\n\n 2\\. Patients of Borderline Personality Disorder experiencing psychological distress,low level of quality of life, social support, emotional dysregulation would be included.\n\n 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\n* Exclusion criteria\n\nThe study would have the following exclusion criteria:\n\n1. Hospitalized patients of Borderline Personality\n2. Patients with Borderline Personality having other chronic co-morbid diseases such as cancer, cognitive deficits, and other chronic psychological disorders.\n3. Patients with Borderline Personality younger than 18 years of age'}, 'identificationModule': {'nctId': 'NCT06699732', 'briefTitle': 'Impact of Mindful Self-Compassion Therapy on Self Harm Behaviors, Emotional Regulation and Quality of Life Among Patients With Borderline Personality Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Fatima Jinnah Women University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'FJWU/EC/2024/94'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Who receives intervention i.e. Mindful Self Compassion Therapy', 'interventionNames': ['Behavioral: Mindful Self Compassion Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Waitlist Control', 'description': 'Who would receive intervention after study completion', 'interventionNames': ['Behavioral: Mindful Self Compassion Therapy']}], 'interventions': [{'name': 'Mindful Self Compassion Therapy', 'type': 'BEHAVIORAL', 'description': 'Mindful Self-Compassion (MSC) therapy is an 8-week program blending mindfulness and self-compassion to improve emotional resilience and well-being.\n\nWeek 1: Introduction - Learn the basics of mindfulness, self-compassion, and reframing self-critical thoughts with kindness.\n\nWeek 2: Mindfulness - Practice observing thoughts and emotions without judgment to build self-awareness.\n\nWeek 3: Self-Kindness - Develop skills to treat yourself with warmth and care during difficult times.\n\nWeek 4: Common Humanity - Explore shared human experiences to reduce feelings of isolation.\n\nWeek 5: Working with Challenges - Learn strategies to respond compassionately to emotional pain.\n\nWeek 6: Growing Compassion - Deepen compassion for yourself and others through guided exercises.\n\nWeek 7: Resilience Building - Strengthen coping skills and foster emotional flexibility.\n\nWeek 8: Integration - Consolidate skills to maintain self-compassion in daily life.', 'armGroupLabels': ['Experimental', 'Waitlist Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Commandant Afimh', 'role': 'CONTACT', 'phone': '0320 5080050'}, {'name': 'Asma Mansoor, PhD Scholar', 'role': 'CONTACT', 'email': 'asmansoor31@yahoo.com', 'phone': '03365374633'}, {'name': 'Asma Mansoor, PhD Scholar', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Commandant Afimh', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}, {'zip': '46000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Medical, Superintendent', 'role': 'CONTACT', 'phone': '(051) 5124470'}, {'name': 'Asma Mansoor', 'role': 'CONTACT', 'email': 'asmansoor31@yahoo.com'}, {'name': 'Asma Mansoor, PhD Scholar', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sehrish Khan', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Farid Family Hospital', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'centralContacts': [{'name': 'Asma Mansoor, PhD Scholar', 'role': 'CONTACT', 'email': 'asmansoor31@yahoo.com', 'phone': '+923365374633'}, {'name': 'Sajida Naz, PhD', 'role': 'CONTACT', 'email': 'dr.sajida@fjwu.edu.pk', 'phone': '+923235493535'}], 'overallOfficials': [{'name': 'Asma Mansoor, PhD Scholar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fatima Jinnah Women University, Rawalpindi, Pakistan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to ethical concerns the data will not be shared. All research findings will be published in aggregate form maintaining patient anonymity'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatima Jinnah Women University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Asma Mansoor', 'investigatorAffiliation': 'Fatima Jinnah Women University'}}}}