Ignite Creation Date:
2025-12-24 @ 1:07 PM
Ignite Modification Date:
2025-12-30 @ 3:36 PM
Study NCT ID:
NCT06926361
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-09
First Post:
2025-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Mindfulness-based Interventions on Improving Teacher Wellbeing and Teaching Outcomes: A Multi-site, Mixed-methods Randomized Controlled Study
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': 'D064866', 'term': 'Mindfulness'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2025-04-07', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Trait mindfulness', 'timeFrame': 'Baseline, 9 weeks, and 3 months post-intervention', 'description': 'The Five-Facet Mindfulness Questionnaire (FFMQ-15). Participants give ratings on a 5-point Likert scale from 1 (never or very rarely true) to 5 (very often or always true). A higher total score means a higher level of trait mindfulness.'}, {'measure': 'Emotion regulation', 'timeFrame': 'Baseline, 9 weeks, and 3 months post-intervention', 'description': 'The Emotion Regulation Questionnaire (ERQ). Participants will rate their responses on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). A higher total score in each subscale indicates a higher tendency of using the specific emotion regulation strategy.'}], 'primaryOutcomes': [{'measure': 'Teaching efficacy', 'timeFrame': 'Baseline, 9 weeks, and 3 months post-intervention', 'description': "The Teachers' Sense of Efficacy Scale-Short Form (TSES-SF). Participants will rate their responses on a 9-point Likert scale ranging from 1 (nothing) to 9 (a great deal). A higher total score indicates a higher sense of teaching efficacy of teachers."}, {'measure': 'Teaching practices', 'timeFrame': 'Baseline, 9 weeks, and 3 months post-intervention', 'description': 'The Classroom Strategies Scale-Teacher Form (CSS-T). Participants will rate their frequency of using a specific strategy in two domains on a 7-point Likert scale from 1 (never used) to 7 (always used). Higher scores indicate teachers use specific strategies more frequently.'}, {'measure': 'Classroom climate', 'timeFrame': 'Baseline, 9 weeks, and 3 months post-intervention', 'description': 'Three subscales of Delaware School Climate Scale-Teacher/Staff (DSCS-T/S): Student-Student Relations, Student Engagement, and Clarity of Expectations. It uses a 4-point Likert scale from 1 (disagree a lot) to 4 (agree a lot). A higher total score indicates a better classroom climate.'}], 'secondaryOutcomes': [{'measure': 'Stress', 'timeFrame': 'Baseline, 9 weeks, and 3 months post-intervention', 'description': 'The Perceived Stress Scale. Participates rate their stress on a 5-point Likert scale ranging from 0 (never) to 4 (very often). A higher total score indicates higher stress levels.'}, {'measure': 'Anxiety', 'timeFrame': 'Baseline, 9 weeks, and 3 months post-intervention', 'description': 'Generalized Anxiety Disorder Assessment (GAD-7). The items are rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day) over the past two weeks. A higher total score indicates a higher level of anxiety.'}, {'measure': 'Depression', 'timeFrame': 'Baseline, 9 weeks, and 3 months post-intervention', 'description': 'The Patient Health Questionnaire-9 (PHQ-9). The items are rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day) over the past two weeks. A higher total score indicates higher depressive symptoms.'}, {'measure': 'Burnout', 'timeFrame': 'Baseline, 9 weeks, and 3 months post-intervention', 'description': 'Maslach Burnout Inventory - Educators Survey (MBI-ES). Participants report scores on a 7-point Likert scale ranging from 0 (never) to 6 (every day). A higher total score indicates a higher level of burnout.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness', 'Teachers', 'School', 'Professional development'], 'conditions': ['Mental Health', 'Teaching Skills']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effectiveness of MBCT-L among Chinese teachers on their mental well-being and teaching outcomes and explore the mechanisms of how mindfulness practice brings these benefits. The study is a multi-site, mixed-methods randomized controlled trial including 160 teachers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Teachers aged 21-65 years;\n2. Teachers currently working in a school; and\n3. Teachers willing to commit time for the 8-week course.\n\nExclusion Criteria:\n\n1. Teachers previously joined a related group mindfulness-based intervention, such as mindfulness-based cognitive therapy (MBCT), mindfulness-based stress reduction (MBSR), Mindfulness - Finding Peace in a Frantic World (FPFW); or\n2. Teachers who are mentally unstable or having active suicidal risk.'}, 'identificationModule': {'nctId': 'NCT06926361', 'briefTitle': 'Effects of Mindfulness-based Interventions on Improving Teacher Wellbeing and Teaching Outcomes: A Multi-site, Mixed-methods Randomized Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Effects of Mindfulness-based Interventions on Improving Teacher Wellbeing and Teaching Outcomes', 'orgStudyIdInfo': {'id': 'SBRE-24-0445'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness for Life', 'description': 'MBCT-L is an 8-week program consisting of mindfulness practices and cognitive-behavioral techniques with 8 sessions (2 hours and 15 minutes per session) and one-day retreat that can provide participants with an extended period to deepen their personal mindfulness practices.', 'interventionNames': ['Behavioral: Mindfulness for Life']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Positive education training', 'description': "Positive Education program is an 8-week course consisting of theories and activities of positive psychology to enhance teachers' skills to support students' learning and wellbeing using a strength-based approach.", 'interventionNames': ['Behavioral: Positive education training']}], 'interventions': [{'name': 'Mindfulness for Life', 'type': 'BEHAVIORAL', 'description': 'Behavioral: Mindfulness for Life (MBCT-L) MBCT-L is an 8-week program consisting of mindfulness practices and cognitive-behavioral techniques with 8 sessions (2 hours and 15 minutes per session) and one-day retreat that can provide participants with an extended period to deepen their personal mindfulness practices.', 'armGroupLabels': ['Mindfulness for Life']}, {'name': 'Positive education training', 'type': 'BEHAVIORAL', 'description': "Positive Education program is an 8-week course consisting of theories and activities of positive psychology to enhance teachers' skills to support students' learning and wellbeing using a strength-based approach.", 'armGroupLabels': ['Positive education training']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jennifer Tang, PhD', 'role': 'CONTACT', 'email': 'jymtang@cuhk.edu.hk', 'phone': '852-39435677'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'The University of Hong Kong', 'class': 'OTHER'}, {'name': 'University of Macau', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jennifer Yee Man Tang', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}