Viewing Study NCT07437092


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Study NCT ID: NCT07437092
Status: NOT_YET_RECRUITING
Last Update Posted: 2026-03-02
First Post: 2026-02-20
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Facilitating Psychological Closure and Emotional Change Through Mindfulness Meditation
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-20', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Memory Characteristics', 'timeFrame': 'Immediately after the intervention (post-test)', 'description': 'Using the Memory Experience Questionnaire Short-Form. Measures distinct qualities of autobiographical memory (e.g., coherence, vividness, visual perspective).\n\nItems are rated on a 5-point Likert scale (1 = Strongly disagree, 5 = Strongly agree), with higher scores indicating greater endorsement of a given memory characteristic.'}, {'measure': 'State Mindfulness (Manipulation Check)', 'timeFrame': 'Immediately after the intervention (post-test)', 'description': "Using the State Mindfulness Scale. Administered as a manipulation check to measure participants' reports of mindful states during the assigned tasks.\n\nItems are rated on a 5-point Likert scale (1 = Not at all, 5 = Very well), with higher scores indicating greater states of mindfulness."}], 'primaryOutcomes': [{'measure': 'Pre- to Post-Test Changes in Psychological Closure using the Closure and Resolution Scale (CRS)', 'timeFrame': 'Baseline (24-72 hours prior to the intervention) and post-test (immediately after intervention)', 'description': 'Items are rated on a 7-point Likert scale (1 = Completely disagree, 7 = Completely agree), with higher scores reflecting greater levels of closure and resolution.'}, {'measure': 'Pre- to Post-Test Changes in Negative Emotion using the Positive and Negative Affect Schedule (PANAS)', 'timeFrame': 'Baseline (24-72 hours prior to the intervention) and post-test (immediately after intervention)', 'description': 'Items are rated on a 5-point Likert scale (1 = Not at all, 5 = Extremely), with higher scores reflecting a stronger endorsement of that emotional experience.'}], 'secondaryOutcomes': [{'measure': 'Experiential Acceptance Towards Thoughts and Emotions', 'timeFrame': 'Immediately after the intervention (post-test)', 'description': 'Using the acceptance subscale of The Southampton Experiential Avoidance and Acceptance Scale.\n\nItems are rated on a 7-point Likert scale (1 = Strongly disagree, 7 = Strongly agree), with higher scores indicating greater levels of openness towards internal experience.'}, {'measure': 'Reappraisal', 'timeFrame': 'Immediately after the intervention (post-test)', 'description': 'Using the Regulation of Emotion Systems Survey. Items are rated on a 5-point Likert scale (1 = Strongly disagree, 5 = Strongly agree), with higher scores indicating greater engagement in reappraisal during the assigned task.'}, {'measure': 'State Decentering', 'timeFrame': 'Immediately after the intervention (post-test)', 'description': 'Using the Metacognitive Processes of Decentering-state scale. Items are rated on an 11-point Likert scale (0 = Not at all, 10 = Very much), with higher scores reflecting greater levels of state decentering (i.e., being aware of, disidentified with, and nonreactive to thoughts and emotions).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Unresolved memories', 'Psychological closure', 'Closure', 'Mindfulness meditation'], 'conditions': ['Unresolved Event Memories', 'Psychological Closure']}, 'referencesModule': {'references': [{'pmid': '25894806', 'type': 'BACKGROUND', 'citation': 'Luchetti M, Sutin AR. Measuring the phenomenology of autobiographical memory: A short form of the Memory Experiences Questionnaire. Memory. 2016;24(5):592-602. doi: 10.1080/09658211.2015.1031679. Epub 2015 Apr 20.'}, {'type': 'BACKGROUND', 'citation': 'De France, K., & Hollenstein, T. (2017). Assessing emotion regulation repertoires: The Regulation of Emotion Systems Survey. Personality and Individual Differences, 119, 204-215. https://doi.org/10.1016/j.paid.2017.07.018'}, {'type': 'BACKGROUND', 'citation': 'McAndrews, Z., Hart, C. M., & Stopa, L. (2024). Development of the Southampton Experiential Avoidance and Acceptance Scale (SEAAS). Journal of Contextual Behavioral Science, 33, 100822-. https://doi.org/10.1016/j.jcbs.2024.100822'}, {'pmid': '24059475', 'type': 'BACKGROUND', 'citation': 'Tanay G, Bernstein A. State Mindfulness Scale (SMS): development and initial validation. Psychol Assess. 2013 Dec;25(4):1286-99. doi: 10.1037/a0034044. Epub 2013 Sep 23.'}, {'pmid': '3397865', 'type': 'BACKGROUND', 'citation': 'Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.'}, {'pmid': '32700920', 'type': 'BACKGROUND', 'citation': 'Hanley AW, Bernstein A, Nakamura Y, Hadash Y, Rojas J, Tennant KE, Jensen RL, Garland EL. The Metacognitive Processes of Decentering Scale: Development and initial validation of trait and state versions. Psychol Assess. 2020 Oct;32(10):956-971. doi: 10.1037/pas0000931. Epub 2020 Jul 23.'}, {'pmid': '39561135', 'type': 'BACKGROUND', 'citation': 'Boucher CM, Scoboria A, Soucie K, Pascual-Leone A. Development and validation of the Closure and Resolution Scale (CRS). Memory. 2025 Feb;33(2):205-222. doi: 10.1080/09658211.2024.2427666. Epub 2024 Nov 19.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if mindfulness meditation can improve closure and emotion towards unresolved memories in an undergraduate student population. This will be tested through a brief, novel intervention called Mindful Recollection, where participants transition immediately from mindfulness meditation into the recollection of an unresolved memory. The secondary aim of the study is to investigate the mechanisms of change underlying Mindful Recollection. Overall then, the main questions this study aims to answer are:\n\n* Does mindful recollection reduce negative emotions associated with unresolved event memories?\n* Can increases in acceptance, decentering, and reappraisal account for the observed effects of mindful recollection on negative emotion?\n* Does mindful recollection facilitate closure towards unresolved event memories?\n* Can increases in acceptance, decentering, and reappraisal account for the observed effects of mindful recollection on closure?\n\nResearchers will compare the Mindful Recollection intervention to a mind-wandering control task to see if mindfulness meditation uniquely produces positive changes in emotion and closure above and beyond placebo. Mindful Recollection will involve a 13-minute audio-guided mindfulness meditation followed immediately by 2 minutes of memory recollection. The control task will involve 13-minutes of audio-guided mind-wandering followed immediately by 2 minutes of memory recollection.\n\nParticipants will:\n\n* Complete pretest measures of emotion and closure towards an unresolved event memory.\n* Engage in either the Mindful Recollection intervention or the placebo control task after a 24-72 hour delay.\n* Complete post-test measures of emotion and closure towards the same unresolved event memory.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to hear and understand spoken instructions clearly; English language proficiency\n\nExclusion Criteria:\n\n* Trauma history/Dissociative tendencies'}, 'identificationModule': {'nctId': 'NCT07437092', 'briefTitle': 'Facilitating Psychological Closure and Emotional Change Through Mindfulness Meditation', 'organization': {'class': 'OTHER', 'fullName': 'University of Windsor'}, 'officialTitle': 'Mindful Recollection: Attending to the Present Before Resolving the Past', 'orgStudyIdInfo': {'id': 'REB #25-135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindful Recollection', 'interventionNames': ['Behavioral: Mindfulness Meditation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Mind-Wandering', 'interventionNames': ['Behavioral: Mind-Wandering Task']}], 'interventions': [{'name': 'Mindfulness Meditation', 'type': 'BEHAVIORAL', 'description': 'Mindful Recollection consists of a 15-minute audio-guided task (13 minutes of guided meditation followed immediately by 2 minutes of unresolved event recollection). The 13-minute guided meditation is intended to facilitate a broad mindful awareness by working through sensations of the breath, body, and mind (in that respective order), eventually coming together in a practice of open monitoring - the non-selective observation of any and all aspects of experience. The 2-minute recollection period will have participants transition from meditating to recalling and reflecting on an unresolved memory they identified during the pretest period (approximately 24-72 hours prior).', 'armGroupLabels': ['Mindful Recollection']}, {'name': 'Mind-Wandering Task', 'type': 'BEHAVIORAL', 'description': 'The mind-wandering control task consists of a 15-minute audio-guided task (13 minutes of mind-wandering followed immediately by 2 minutes of unresolved event recollection). Mind-wandering is a common sham mindfulness technique that repeatedly prompts participants to let their thoughts flow freely, thinking about whatever comes to mind. This exposes participants to the same procedure (i.e., listening to a 13-minute audio-recording) without receiving guided mindful meditation instructions. Thus, this condition will guide participants to have a typical mental experience of thinking freely about whatever comes to mind, without developing a mindful awareness of their internal experience.', 'armGroupLabels': ['Mind-Wandering']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N9B 3P4', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Anas Alsayed Hasan', 'role': 'CONTACT', 'email': 'alsayed4@uwindsor.ca', 'phone': '647-224-1595'}], 'facility': 'University of Windsor', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}], 'centralContacts': [{'name': 'Anas Alsayed Hasan', 'role': 'CONTACT', 'email': 'alsayed4@uwindsor.ca', 'phone': '647-224-1595'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Windsor', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MA Student', 'investigatorFullName': 'Anas Alsayed Hasan', 'investigatorAffiliation': 'University of Windsor'}}}}