Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-20 @ 8:08 PM
Study NCT ID:
NCT02655835
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2016-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet Mindfulness Meditation Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-25', 'studyFirstSubmitDate': '2016-01-06', 'studyFirstSubmitQcDate': '2016-01-12', 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment rate', 'timeFrame': 'Week 0 - Screening', 'description': 'Number of participants who are eligible and enroll in the study'}, {'measure': 'Participant satisfaction', 'timeFrame': 'Week 8 - Endpoint assessment', 'description': 'Client Satisfaction Questionnaire'}, {'measure': 'Number of internet mindfulness meditation training sessions completed', 'timeFrame': 'Week 8 - Endpoint Assessment (after intervention is complete)', 'description': 'There are a total of 6 internet training sessions, and participants are instructed to complete one per week (where Week 0 is screening, Week 1 is Baseline Assessment, Week 2 is Training 1, Week 3 is Training 2, Week 4 is Training 3, Week 5 is Training 4, Week 6 is Training 5, and Week 7 is Training 6) . At the time of the endpoint assessment (Week 8), the number of completed training sessions is tabulated.'}, {'measure': 'Completion Rate', 'timeFrame': 'Week 8 - Endpoint assessment', 'description': 'Number of participants who complete the endpoint assessment.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life SF-36', 'timeFrame': 'Week 1 - Baseline assessment & Week 8 - Endpoint assessment', 'description': 'Measured with Short-Form Health Survey (SF-36) self-report measure'}, {'measure': 'Self-efficacy', 'timeFrame': 'Week 1 - Baseline assessment & Week 8 - Endpoint assessment', 'description': 'Measured with General Perceived Self Efficacy (GPSE) self-report questionnaire'}, {'measure': 'Mood', 'timeFrame': 'Week 1 - Baseline assessment & Week 8 - Endpoint assessment', 'description': 'Measured with Center for Epidemiological Studies Depression Scale (CESD) self-report questionnaire'}, {'measure': 'Sleep', 'timeFrame': 'Week 1 - Baseline assessment & Week 8 - Endpoint assessment', 'description': 'Measured with Pittsburgh Sleep Quality Index (PSQI) self-report questionnaire'}, {'measure': 'Mindfulness', 'timeFrame': 'Week 1 - Baseline assessment & Week 8 - Endpoint assessment', 'description': 'Measured with Five Factor Mindfulness Questionnaire (FFMQ)'}, {'measure': 'Perceived Stress', 'timeFrame': 'Week 1 - Baseline assessment & Week 8 - Endpoint assessment', 'description': 'Measured with perceived stress scale (PSS)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mindfulness', 'meditation', 'internet'], 'conditions': ['Stress']}, 'referencesModule': {'references': [{'pmid': '27502759', 'type': 'DERIVED', 'citation': 'Wahbeh H, Oken BS. Internet Mindfulness Meditation Intervention for the General Public: Pilot Randomized Controlled Trial. JMIR Ment Health. 2016 Aug 8;3(3):e37. doi: 10.2196/mental.5900.'}]}, 'descriptionModule': {'briefSummary': "Phase 1 will follow 40 subjects and hopes to address whether or not IMMI can increase meditation practice as compared to another meditation program. The study will last six weeks for both the IMMI group (20 subjects) and the Access group (20 subjects). Access groups will receive learning materials and guided meditations, but the implementation will be self-paced. Participants in the IMMI group will receive weekly learning sessions and be required to practice meditation every day. IMMI group participants will also receive a weekly reminder call from a member of the study staff and have access to technical support in the event of trouble with the online program. All subjects will complete online self-report questionnaires that measure quality of life, self-efficacy, mood, sleep, mindfulness, and perceived stress at baseline and at the end of the six-week intervention. Subjects will also be given a questionnaire at the end of the study gauging their satisfaction with the mindfulness program they participated in.\n\nPhase 2 will follow 80 subjects and hopes to address whether or not IMMI is acceptable to participants and demographic information about IMMI users. The study will be the same as noted above, but all subjects will be entered in the IMMI program.\n\nDifferences in recruitment rates, drop out, and patient satisfaction between the IMMI and Access groups will be analyzed. IMMI's ability to change meditation behavior (i.e. increasing time or frequency of meditation sessions), and improve quality of life will be examined as well.", 'detailedDescription': 'Participants will undergo the following: Week 0 - Telephone screening; Week 1 - Baseline Assessment; Week 2-Week 7 - Internet Mindfulness Meditation Intervention (or Access in Phase 1); Week 8 - Endpoint Assessment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 - 80 years old\n* Access to Computer and Internet\n* Can hear and understand instructions\n* Willing to accept randomization scheme and agrees to follow the study protocol\n\nExclusion Criteria:\n\n* Significant acute medical illness that would decrease likelihood of study completion (self-report)\n* Significant, untreated depression, as assessed by CESD-5 \\>20 during screening\n* Current daily meditation practice (≥ 5 min/day daily for at least 30 days in the last 6 months. Past practice not exclusionary but will be recorded)'}, 'identificationModule': {'nctId': 'NCT02655835', 'acronym': 'IMMI', 'briefTitle': 'Internet Mindfulness Meditation Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Internet Mindfulness Meditation Intervention', 'orgStudyIdInfo': {'id': '10939'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet Mindfulness Meditation Intervention', 'description': 'Six-week internet mindfulness meditation training program including handouts and daily guided meditations', 'interventionNames': ['Behavioral: Internet Mindfulness Meditation']}, {'type': 'EXPERIMENTAL', 'label': 'Access', 'description': 'Written information handouts on mindfulness meditation and access to guided daily meditations', 'interventionNames': ['Behavioral: Access']}], 'interventions': [{'name': 'Internet Mindfulness Meditation', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Internet Mindfulness Meditation Intervention']}, {'name': 'Access', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Access']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Barry S Oken, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ND, MCR', 'investigatorFullName': 'Helane Wahbeh', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}