Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 3:57 AM
Study NCT ID:
NCT07468994
Status:
COMPLETED
Last Update Posted:
2026-03-13
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the MindUP Program on Depression, Anxiety, and Stress in Pakistani Orphan Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were assigned to two parallel groups: an intervention group receiving the MindUP mindfulness-based program and a comparison group receiving routine institutional activities. Outcomes were measured at baseline and post-intervention to assess changes in depression, anxiety, and stress.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2024-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Depression Symptoms (DASS-21 Depression Subscale)', 'timeFrame': 'Baseline to Post-Intervention (15 weeks)', 'description': 'Depression symptoms were measured using the Depression subscale of the Depression Anxiety Stress Scales (DASS-21). Higher scores indicate greater levels of depressive symptoms. Changes from baseline to post-intervention were assessed to evaluate the effectiveness of the MindUP program.'}], 'secondaryOutcomes': [{'measure': 'Change in Stress Levels (DASS-21 Stress Subscale)', 'timeFrame': 'Baseline to Post-Intervention (15 weeks)'}, {'measure': 'Change in Anxiety Symptoms (DASS-21 Anxiety Subscale)', 'timeFrame': 'Baseline to Post-Intervention (15 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MindUP', 'Mindfulness Intervention', 'Orphan Adolescents', 'Mental Health', 'Pakistan', 'School based intervention'], 'conditions': ['Depression', 'Anxiety', 'Stress']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of the MindUP mindfulness-based program in reducing depression, anxiety, and stress among orphan adolescents in Pakistan. Adolescents living in orphan care institutions often experience significant psychological distress due to early life adversity, loss of parental support, and institutional living conditions.\n\nA school-based quasi-experimental design was used to examine whether participation in the MindUP program improves mental health outcomes among orphan adolescents. Participants were adolescents residing in orphanages in Pakistan who were assigned to either an intervention group receiving the MindUP program or a comparison group receiving routine institutional activities.\n\nThe MindUP intervention consisted of structured mindfulness and social-emotional learning sessions designed to enhance emotional regulation, attention, and psychological well-being. The program was delivered over several weeks by trained facilitators.\n\nPsychological outcomes including depression, anxiety, and stress were measured using standardized self-report scales before and after the intervention. The study aims to determine whether the MindUP program is effective in improving mental health among orphan adolescents in low-resource institutional settings.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male adolescents aged 11-16 years.\n\nResiding in an orphan care institution.\n\nCurrently enrolled in school (grades 7-8).\n\nAble to understand and participate in the MindUP program sessions.\n\nProvided assent to participate and permission obtained from the institutional authorities/guardians.\n\nExclusion Criteria:\n\n* Adolescents currently receiving psychological or psychiatric treatment.\n\nAdolescents with severe cognitive or developmental disorders that would interfere with participation in the intervention.\n\nAdolescents who did not complete baseline assessments or were absent for most intervention sessions.'}, 'identificationModule': {'nctId': 'NCT07468994', 'acronym': 'MINDUP-PAK', 'briefTitle': 'Effect of the MindUP Program on Depression, Anxiety, and Stress in Pakistani Orphan Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Quaid-e-Azam University'}, 'officialTitle': 'Does MindUP Work With Pakistani Orphan Adolescents? Assessing Its Efficacy in Lowering Depression, Anxiety and Stress', 'orgStudyIdInfo': {'id': 'NIP-MINDUP-2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MindUP Intervention Group', 'description': 'Participants in this group received the MindUP mindfulness-based intervention program designed to improve emotional regulation, attention, and psychological well-being. The program consisted of structured sessions focusing on mindfulness practices, social-emotional learning, and awareness exercises delivered over several weeks.', 'interventionNames': ['Behavioral: MindUP Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants in this group continued their routine institutional activities and did not receive the MindUP intervention during the study period. Psychological outcomes were assessed at the same time points as the intervention group.'}], 'interventions': [{'name': 'MindUP Program', 'type': 'BEHAVIORAL', 'description': 'MindUP is a mindfulness-based social and emotional learning program that teaches participants skills related to mindful awareness, emotional regulation, attention, and stress management through structured exercises and activities.', 'armGroupLabels': ['MindUP Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Islamabad', 'state': 'Islamabad', 'country': 'Pakistan', 'facility': 'Aghosh Alkhidmat Foundation College Murree', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'overallOfficials': [{'name': 'Rubina Hanif, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quaid-i-Azam University, Islamabad.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quaid-e-Azam University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Scholar, Department of Psychology', 'investigatorFullName': 'Atteen Rohail', 'investigatorAffiliation': 'Quaid-e-Azam University'}}}}