Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-02-13 @ 8:30 AM
Study NCT ID:
NCT05197595
Status:
UNKNOWN
Last Update Posted:
2023-10-18
First Post:
2022-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Compassion Program in University Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012064', 'term': 'Relaxation Therapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2022-01-05', 'studyFirstSubmitQcDate': '2022-01-05', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The Relationship Questionnaire (RQ)', 'timeFrame': 'Baseline', 'description': 'In the compassion condition group'}, {'measure': 'The Relationship Questionnaire (RQ)', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'The Relationship Questionnaire (RQ)', 'timeFrame': 'Post-treatment 6 weeks from baseline', 'description': 'In the compassion condition group'}, {'measure': 'The Relationship Questionnaire (RQ)', 'timeFrame': 'Post-treatment 6 weeks from baseline', 'description': 'In the relaxation program group'}, {'measure': 'The Relationship Questionnaire (RQ)', 'timeFrame': 'Six-months follow-up', 'description': 'In the compassion condition group'}, {'measure': 'The Relationship Questionnaire (RQ)', 'timeFrame': 'Six-months follow-up', 'description': 'In the relaxation program group'}, {'measure': 'Acceptance and Action Questionnaire-II (AAQ-II)', 'timeFrame': 'Baseline', 'description': 'In the compassion condition group'}, {'measure': 'Acceptance and Action Questionnaire-II (AAQ-II)', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'Acceptance and Action Questionnaire-II (AAQ-II)', 'timeFrame': 'Post-treatment 6 weeks from baseline', 'description': 'In the compassion condition group'}, {'measure': 'Acceptance and Action Questionnaire-II (AAQ-II)', 'timeFrame': 'Post-treatment 6 weeks from baseline', 'description': 'In the relaxation program group'}, {'measure': 'Acceptance and Action Questionnaire-II (AAQ-II)', 'timeFrame': 'Six-months follow-up', 'description': 'In the compassion condition group'}, {'measure': 'Acceptance and Action Questionnaire-II (AAQ-II)', 'timeFrame': 'Six-months follow-up', 'description': 'In the relaxation program group'}, {'measure': 'Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)', 'timeFrame': 'Baseline', 'description': 'In the compassion condition group'}, {'measure': 'Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)', 'timeFrame': 'Post-treatment 6 weeks from baseline', 'description': 'In the compassion condition group'}, {'measure': 'Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)', 'timeFrame': 'Post-treatment 6 weeks from baseline', 'description': 'In the relaxation program group'}, {'measure': 'Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)', 'timeFrame': 'Six-months follow-up', 'description': 'In the compassion condition group'}, {'measure': 'Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)', 'timeFrame': 'Six-months follow-up', 'description': 'In the relaxation program group'}, {'measure': 'Five Facets of Mindfulness Questionnaire (FFMQ)', 'timeFrame': 'Baseline', 'description': 'In the compassion condition group'}, {'measure': 'Five Facets of Mindfulness Questionnaire (FFMQ)', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'Five Facets of Mindfulness Questionnaire (FFMQ)', 'timeFrame': 'Post-treatment 6 weeks from baseline', 'description': 'In the compassion condition group'}, {'measure': 'Five Facets of Mindfulness Questionnaire (FFMQ)', 'timeFrame': 'Post-treatment 6 weeks from baseline', 'description': 'In the relaxation program group'}, {'measure': 'Five Facets of Mindfulness Questionnaire (FFMQ)', 'timeFrame': 'Six-months follow-up', 'description': 'In the compassion condition group'}, {'measure': 'Five Facets of Mindfulness Questionnaire (FFMQ)', 'timeFrame': 'Six-months follow-up', 'description': 'In the relaxation program group'}], 'primaryOutcomes': [{'measure': 'Depression Anxiety and Stress Scale - 21 (DASS-21)', 'timeFrame': 'Baseline', 'description': 'In the compassion program group'}, {'measure': 'Depression Anxiety and Stress Scale - 21 (DASS-21)', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'Depression Anxiety and Stress Scale - 21 (DASS-21)', 'timeFrame': 'Post-treatment 6 weeks from baseline', 'description': 'In the compassion condition group'}, {'measure': 'Depression Anxiety and Stress Scale - 21 (DASS-21)', 'timeFrame': 'Post-treatment 6 weeks from baseline', 'description': 'In the relaxation program group'}, {'measure': 'Depression Anxiety and Stress Scale - 21 (DASS-21)', 'timeFrame': 'Six-months follow-up', 'description': 'In the compassion condition group'}, {'measure': 'Depression Anxiety and Stress Scale - 21 (DASS-21)', 'timeFrame': 'Six-months follow-up', 'description': 'In the relaxation program group'}], 'secondaryOutcomes': [{'measure': 'Sociodemographic data Gender, age, marital status, education, occupation, economical level', 'timeFrame': 'Baseline', 'description': 'In the compassion condition group'}, {'measure': 'Sociodemographic data Gender, age, marital status, education, occupation, economical level', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'Positive and negative affect (PANAS)', 'timeFrame': 'Baseline', 'description': 'In the compassion condition group'}, {'measure': 'Positive and negative affect (PANAS)', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'Positive and negative affect (PANAS)', 'timeFrame': 'Post-treatment 6 weeks from baseline', 'description': 'In the compassion condition group'}, {'measure': 'Positive and negative affect (PANAS)', 'timeFrame': 'Post-treatment 6 weeks from baseline', 'description': 'In the relaxation program group'}, {'measure': 'Positive and negative affect (PANAS)', 'timeFrame': 'Six-months follow-up', 'description': 'In the compassion condition group'}, {'measure': 'Positive and negative affect (PANAS)', 'timeFrame': 'Six-months follow-up', 'description': 'In the relaxation program group'}, {'measure': 'Emotional Regulation Questionnaire (ERQ)', 'timeFrame': 'Baseline', 'description': 'In the compassion condition group'}, {'measure': 'Emotional Regulation Questionnaire (ERQ)', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'Emotional Regulation Questionnaire (ERQ)', 'timeFrame': 'Post-treatment 6 weeks from baseline', 'description': 'In the compassion condition group'}, {'measure': 'Emotional Regulation Questionnaire (ERQ)', 'timeFrame': 'Post-treatment 6 weeks from baseline', 'description': 'In the relaxation program group'}, {'measure': 'Emotional Regulation Questionnaire (ERQ)', 'timeFrame': 'Six-months follow-up', 'description': 'In the compassion condition group'}, {'measure': 'Emotional Regulation Questionnaire (ERQ)', 'timeFrame': 'Six-months follow-up', 'description': 'In the relaxation program group'}, {'measure': 'Maslach Burnout Inventory Student Survey (MBI-SS)', 'timeFrame': 'Baseline', 'description': 'In the compassion condition group'}, {'measure': 'Maslach Burnout Inventory Student Survey (MBI-SS)', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'Maslach Burnout Inventory Student Survey (MBI-SS)', 'timeFrame': 'Post-treatment 6 weeks from baseline', 'description': 'In the compassion condition group'}, {'measure': 'Maslach Burnout Inventory Student Survey (MBI-SS)', 'timeFrame': 'Post-treatment 6 weeks from baseline', 'description': 'In the relaxation program group'}, {'measure': 'Maslach Burnout Inventory Student Survey (MBI-SS)', 'timeFrame': 'Six-months follow-up', 'description': 'In the compassion condition group'}, {'measure': 'Maslach Burnout Inventory Student Survey (MBI-SS)', 'timeFrame': 'Six-months follow-up', 'description': 'In the relaxation program group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Attachment-based compassion therapy', 'Students', 'Psychological well-being'], 'conditions': ['Mental Health Wellness']}, 'referencesModule': {'references': [{'pmid': '37691796', 'type': 'DERIVED', 'citation': 'Beltran-Ruiz M, Fernandez S, Garcia-Campayo J, Puebla-Guedea M, Lopez-Del-Hoyo Y, Navarro-Gil M, Montero-Marin J. Effectiveness of attachment-based compassion therapy to reduce psychological distress in university students: a randomised controlled trial protocol. Front Psychol. 2023 Aug 24;14:1185445. doi: 10.3389/fpsyg.2023.1185445. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'University life is a challenging period. College students are exposed to a large number of stressors such as increased workload, multitasking, new responsibilities, changes in sleep and eating habits, social stressors, financial concerns and future employability, unlimited access to technology, etc. The participation of some of them in unhealthy activities should also be noted.\n\nThere is sufficient evidence to affirm that high levels of stress cause different alterations in students, such as attention and concentration deficits, difficulties in memorizing and solving problems, low productivity and poor academic performance. Due to this, in addition to the psychological and social impact of said mental health problems, the academic functioning of the students decreases and the dropout rates increase, which represents a problem for themselves and for the institutions. On the other hand, students and future professionals in training run the risk of suffering burnout as a consequence of the chronic stress to which they are subjected, with the consequent negative effects on their future professional practice.\n\nThe main objective of the present research is to evaluate the efficacy of a six-week compassion program for the reduction of psychological distress in university students compared to an active control condition based on relaxation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: 18-30 years old.\n* Study undergraduate or master's degrees at the University of Zaragoza.\n* Understand perfectly spoken and written Spanish.\n* Grant informed consent.\n\nExclusion Criteria:\n\n* Any diagnose of disease that may affect central nervous system (brain pathology traumatic brain injury, dementia, etc.).\n* Other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders, etc.) except for anxious pathology or personality disorders.\n* Any medical, infectious or degenerative disease that may affect mood, presence of delusional ideas or hallucinations consistent or not with mood, and suicide risk."}, 'identificationModule': {'nctId': 'NCT05197595', 'briefTitle': 'Efficacy of a Compassion Program in University Students', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Miguel Servet'}, 'officialTitle': 'Efficacy of a Compassion Program for the Reduction of Psychological Distress in University Students', 'orgStudyIdInfo': {'id': '18/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Compassion condition', 'description': '90-minute group sessions, held once a week over a space of 6 weeks, and is offered as an extra-curricular activity.', 'interventionNames': ['Behavioral: Attachment-based compassion therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Relaxation condition', 'description': '90-minute group sessions, held once a week over a space of 6 weeks, and will be offered as an extracurricular activity.', 'interventionNames': ['Behavioral: Relaxation program']}], 'interventions': [{'name': 'Attachment-based compassion therapy', 'type': 'BEHAVIORAL', 'description': 'Compassion program consists of 6 sessions of 90 minutes/session (15-20 people) Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months', 'armGroupLabels': ['Compassion condition']}, {'name': 'Relaxation program', 'type': 'BEHAVIORAL', 'description': 'Relaxation program consists of 6 sessions of 90 minutes/session (15-20 people) Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months', 'armGroupLabels': ['Relaxation condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Miguel Servet University Hospital', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Miguel Servet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Javier Garcia Campayo', 'investigatorAffiliation': 'Hospital Miguel Servet'}}}}