Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT05998967
Status:
COMPLETED
Last Update Posted:
2024-03-21
First Post:
2023-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pilot Trial of Mobile Mantram Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ariel.lang@va.gov', 'phone': '(858) 552-8585', 'title': 'Ariel J Lang, PhD, MPH', 'organization': 'VA San Diego HCS'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 week study period', 'eventGroups': [{'id': 'EG000', 'title': 'Self-directed MRP', 'description': 'Self-directed instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Supported MRP', 'description': 'Supported instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 1, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Emotional distress', 'notes': 'Distress related to assessment of mental health symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Eligibility Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Enrolled Sample', 'description': 'All Veterans screened for participation in the study'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0', 'description': 'Rate of eligibility among those screened for participation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Screened individuals'}, {'type': 'PRIMARY', 'title': 'Initiation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eligible Veterans', 'description': 'Number of individuals meeting all eligibility requirements'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Rate of intervention initiation among eligible Veterans', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible individuals'}, {'type': 'PRIMARY', 'title': 'Completion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eligible Veterans', 'description': 'Number of individuals meeting all eligibility requirements'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28', 'description': 'Rate of intervention completion among eligible Veterans', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Credibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-directed MRP', 'description': 'Self-directed instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}, {'id': 'OG001', 'title': 'Supported MRP', 'description': 'Supported instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}], 'classes': [{'categories': [{'measurements': [{'value': '4.78', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '5.23', 'spread': '1.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Average Veteran perception of the logic, utility and expected benefit of treatment rated on a scale of 0 (not at all) to 8 (very)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Abbreviated Client Satisfaction Questionnaire (CSQ-8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-directed MRP', 'description': 'Self-directed instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}, {'id': 'OG001', 'title': 'Supported MRP', 'description': 'Supported instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}], 'classes': [{'categories': [{'measurements': [{'value': '11.75', 'spread': '3.41', 'groupId': 'OG000'}, {'value': '12.92', 'spread': '2.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'description': 'Degree of satisfaction with care received as measured by 4 items from the CSQ-8, creating a 4-item total score. Scores range from 4-16 with higher scores indicating greater satisfaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Acceptability of Intervention Measure (AIM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-directed MRP', 'description': 'Self-directed instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}, {'id': 'OG001', 'title': 'Supported MRP', 'description': 'Supported instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}], 'classes': [{'categories': [{'measurements': [{'value': '4.46', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '4.23', 'spread': '0.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'description': 'Perceived acceptability of the intervention as measured by an AIM average score. Scores range from 1-5 with higher scores indicating greater acceptability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Intervention Appropriateness Measure (IAM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-directed MRP', 'description': 'Self-directed instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}, {'id': 'OG001', 'title': 'Supported MRP', 'description': 'Supported instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}], 'classes': [{'categories': [{'measurements': [{'value': '3.54', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '3.81', 'spread': '0.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'description': 'Perceived appropriateness of the intervention as measured by an IAM average score. Scores range from 1-5 with higher scores indicating greater appropriateness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Feasibility of Intervention Measure (FIM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-directed MRP', 'description': 'Self-directed instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}, {'id': 'OG001', 'title': 'Supported MRP', 'description': 'Supported instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}], 'classes': [{'categories': [{'measurements': [{'value': '4.12', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '3.77', 'spread': '0.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'description': 'Perceived feasibility of the intervention as measured by an FIM average score. Scores range from 1-5 with higher scores indicating greater feasibility.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mantram Practice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-directed MRP', 'description': 'Self-directed instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}, {'id': 'OG001', 'title': 'Supported MRP', 'description': 'Supported instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}], 'classes': [{'categories': [{'measurements': [{'value': '4.93', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '1.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'description': 'Frequency of mantram practice in the past week as 0-7 days', 'unitOfMeasure': 'days/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PTSD Checklist for DSM-5 (PCL-5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-directed MRP', 'description': 'Self-directed instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}, {'id': 'OG001', 'title': 'Supported MRP', 'description': 'Supported instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}], 'classes': [{'categories': [{'measurements': [{'value': '31.00', 'spread': '21.45', 'groupId': 'OG000'}, {'value': '27.71', 'spread': '19.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'description': 'PTSD symptoms at post-treatment as measured by the PCL-5 total score. Scores range from 0-80 with higher scores indicating greater PTSD symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Health Questionnaire Depression Items (PHQ-9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-directed MRP', 'description': 'Self-directed instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}, {'id': 'OG001', 'title': 'Supported MRP', 'description': 'Supported instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}], 'classes': [{'categories': [{'measurements': [{'value': '11.50', 'spread': '8.13', 'groupId': 'OG000'}, {'value': '9.86', 'spread': '6.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'description': 'Depression at post-treatment as measured by the PHQ-9 total score. Scores range from 0-27 with higher scores indicating greater depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Insomnia Severity Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-directed MRP', 'description': 'Self-directed instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}, {'id': 'OG001', 'title': 'Supported MRP', 'description': 'Supported instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}], 'classes': [{'categories': [{'measurements': [{'value': '15.79', 'spread': '7.64', 'groupId': 'OG000'}, {'value': '12.14', 'spread': '8.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'description': 'Insomnia at post-treatment as measured by the ISI total score. Scores range from 0-28 with higher scores indicating greater insomnia.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Self-directed MRP', 'description': 'Self-directed instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}, {'id': 'FG001', 'title': 'Supported MRP', 'description': 'Supported instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Recruited between December 2021 and August 2022 based on clinical referrals and lists of potential research participants', 'preAssignmentDetails': 'Participants had a primary clinical complaint of PTSD and an Internet-enabled device'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Self-directed Mantram Repetition Program (MRP)', 'description': 'Self-directed instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}, {'id': 'BG001', 'title': 'Supported Mantram Repetition Program (MRP)', 'description': 'Supported instruction in MRP via Internet\n\nMobile Mantram Repetition Program: Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.29', 'spread': '16.87', 'groupId': 'BG000'}, {'value': '49.79', 'spread': '14.52', 'groupId': 'BG001'}, {'value': '50.50', 'spread': '15.49', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Vanuatu', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'PTSD Checklist for DSM-5 (PCL-5)', 'classes': [{'categories': [{'measurements': [{'value': '35.94', 'spread': '18.28', 'groupId': 'BG000'}, {'value': '30.56', 'spread': '16.73', 'groupId': 'BG001'}, {'value': '33.17', 'spread': '17.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Scores range from 0-80 with higher scores indicating greater PTSD symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Health Questionnaire depression (PHQ-9)', 'classes': [{'categories': [{'measurements': [{'value': '11.47', 'spread': '6.32', 'groupId': 'BG000'}, {'value': '10.58', 'spread': '5.58', 'groupId': 'BG001'}, {'value': '11.00', 'spread': '5.87', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Scores range from 0-27 with higher scores indicating greater depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Insomnia Severity Index (ISI)', 'classes': [{'categories': [{'measurements': [{'value': '15.94', 'spread': '6.55', 'groupId': 'BG000'}, {'value': '13.00', 'spread': '8.13', 'groupId': 'BG001'}, {'value': '14.39', 'spread': '7.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Scores range from 0-28 with higher scores indicating greater insomnia.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-12', 'size': 266298, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-19T17:57', 'hasProtocol': True}, {'date': '2023-05-18', 'size': 204794, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-08-07T16:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Internet-based instruction in MRP in a self-directed or supported manner'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2023-08-07', 'resultsFirstSubmitDate': '2023-08-24', 'studyFirstSubmitQcDate': '2023-08-14', 'lastUpdatePostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-19', 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eligibility Rate', 'timeFrame': 'Day 0', 'description': 'Rate of eligibility among those screened for participation'}, {'measure': 'Initiation Rate', 'timeFrame': 'Day 1', 'description': 'Rate of intervention initiation among eligible Veterans'}, {'measure': 'Completion Rate', 'timeFrame': 'Day 28', 'description': 'Rate of intervention completion among eligible Veterans'}, {'measure': 'Credibility', 'timeFrame': 'Day 1', 'description': 'Average Veteran perception of the logic, utility and expected benefit of treatment rated on a scale of 0 (not at all) to 8 (very)'}, {'measure': 'Abbreviated Client Satisfaction Questionnaire (CSQ-8)', 'timeFrame': 'Day 28', 'description': 'Degree of satisfaction with care received as measured by 4 items from the CSQ-8, creating a 4-item total score. Scores range from 4-16 with higher scores indicating greater satisfaction.'}, {'measure': 'Acceptability of Intervention Measure (AIM)', 'timeFrame': 'Day 28', 'description': 'Perceived acceptability of the intervention as measured by an AIM average score. Scores range from 1-5 with higher scores indicating greater acceptability.'}, {'measure': 'Intervention Appropriateness Measure (IAM)', 'timeFrame': 'Day 28', 'description': 'Perceived appropriateness of the intervention as measured by an IAM average score. Scores range from 1-5 with higher scores indicating greater appropriateness.'}, {'measure': 'Feasibility of Intervention Measure (FIM)', 'timeFrame': 'Day 28', 'description': 'Perceived feasibility of the intervention as measured by an FIM average score. Scores range from 1-5 with higher scores indicating greater feasibility.'}], 'secondaryOutcomes': [{'measure': 'Mantram Practice', 'timeFrame': 'Day 28', 'description': 'Frequency of mantram practice in the past week as 0-7 days'}, {'measure': 'PTSD Checklist for DSM-5 (PCL-5)', 'timeFrame': 'Day 28', 'description': 'PTSD symptoms at post-treatment as measured by the PCL-5 total score. Scores range from 0-80 with higher scores indicating greater PTSD symptoms.'}, {'measure': 'Patient Health Questionnaire Depression Items (PHQ-9)', 'timeFrame': 'Day 28', 'description': 'Depression at post-treatment as measured by the PHQ-9 total score. Scores range from 0-27 with higher scores indicating greater depression.'}, {'measure': 'Insomnia Severity Index', 'timeFrame': 'Day 28', 'description': 'Insomnia at post-treatment as measured by the ISI total score. Scores range from 0-28 with higher scores indicating greater insomnia.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Internet-based care', 'Meditation', 'Feasibility'], 'conditions': ['PTSD']}, 'descriptionModule': {'briefSummary': 'Mantram Repetition Program (MRP) is a meditation practice that involves silent repetition of a spiritual word, one-pointed attention, and slowing down. It has been shown to help reduce PTSD symptoms among Veterans. This study will look at how Veterans reach to learning MRP via the Internet, either in a self-directed way or with text/phone support.', 'detailedDescription': 'Easily accessible interventions to address post-traumatic stress disorder (PTSD) can play critical role in reducing PTSD and associated symptoms in Veterans, especially for those who remain symptomatic after treatment with other evidence-based interventions, those who prefer complimentary and integrative therapies, or those who have difficulty accessing traditional face-to-face mental health services. The value of these programs is their ability to provide Veterans with more options in their recovery journey and to reach a broad range of Veterans across multiple settings, including remote rural contexts.\n\nThe Mantram Repetition Program (MRP) is a meditation-based practice that consists of the repetition of a spiritual word, one-pointed attention, and slowing down. MRP has been shown to reduce stress in several high-risk populations, and two large randomized, controlled studies show that MRP reduces PTSD symptoms among Veterans. A brief, web-based, self-directed version of MRP has been developed to increase the accessibility of evidence-based PTSD treatment. This version of MRP was tested in a pilot study with undergraduate students, demonstrating its ease of use and success in getting students to engage with the practice. The proposed mixed method study will use the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to evaluate the mobile MRP in Veterans with PTSD in two conditions: self-directed and with text/phone support. Data from this pilot study will inform the refinement of the MRP delivery strategy and the development of a full-scale trial to test its effectiveness and implementation outcomes, as well as barriers and facilitators, and other contextual factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veteran\n* Primary clinical complaint of PTSD\n* Access to an Internet-enabled device\n\nExclusion Criteria:\n\n* Cognitive impairment or mental health concerns that necessitated a higher level of care or interfered with ability to engage in study activities'}, 'identificationModule': {'nctId': 'NCT05998967', 'acronym': 'mMRP', 'briefTitle': 'Pilot Trial of Mobile Mantram Delivery', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Feasibility and Acceptability of Mobile Mantram Repetition Program for Veterans With PTSD (IVI 22-115)', 'orgStudyIdInfo': {'id': 'IVX 23-001'}, 'secondaryIdInfos': [{'id': 'SWIFT-IVI 22-115', 'type': 'OTHER_GRANT', 'domain': 'VA SWIFT IVI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-directed MRP', 'description': 'Self-directed instruction in MRP via Internet', 'interventionNames': ['Behavioral: Mobile Mantram Repetition Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Supported MRP', 'description': 'Supported instruction in MRP via Internet', 'interventionNames': ['Behavioral: Mobile Mantram Repetition Program']}], 'interventions': [{'name': 'Mobile Mantram Repetition Program', 'type': 'BEHAVIORAL', 'otherNames': ['mMRP'], 'description': 'Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down', 'armGroupLabels': ['Self-directed MRP', 'Supported MRP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92161-0002', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VA San Diego Healthcare System, San Diego, CA', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Ariel J. Lang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA San Diego Healthcare System, San Diego, CA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}