Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-28 @ 4:23 PM
Study NCT ID:
NCT05087095
Status:
COMPLETED
Last Update Posted:
2025-04-09
First Post:
2021-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Managing Distress in Malignant Brain Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ashlee.loughan@vcuhealth.org', 'phone': '804-828-9815', 'title': 'Ashlee Loughan, PhD, LCP', 'organization': 'Virginia Commonwealth University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline to three months', 'eventGroups': [{'id': 'EG000', 'title': 'CALM', 'description': 'CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone\n\nCALM Intervention: The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints:\n\n* Within one week before initiating the CALM intervention therapy\n* Within one week after its completion,\n* 3 months after the CALM intervention is complete\n\n * After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CALM', 'description': 'CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone\n\nCALM Intervention: The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints:\n\n* Within one week before initiating the CALM intervention therapy\n* Within one week after its completion,\n* 3 months after the CALM intervention is complete\n\n * After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components'}], 'classes': [{'title': 'Domain 1', 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Domain 2', 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Domain 3', 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Domain 4', 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 Months', 'description': 'At the exit interview, participants will be asked to rate the applicability of the four CALM domains on a Likert Scale from 1 (not applicable) to 5 (very applicable). The four CALM domains are as follows: Domain 1) represents symptom management and communication with healthcare providers, Domain 2) reflects changes in personal relationships, Domain 3) sense of meaning and purpose, and Domain 4) the future, hope and mortality. Higher scores mean greater applicability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Participant Screening, Eligibility, and Consent.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CALM', 'description': 'CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone\n\nCALM Intervention: The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints:\n\n* Within one week before initiating the CALM intervention therapy\n* Within one week after its completion,\n* 3 months after the CALM intervention is complete\n\n * After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components'}], 'classes': [{'title': 'Screened', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Eligible', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Consented', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Determine how many patients consent to screening after referral to the program, how many patients are eligible for the program after being screened, and how many consent/enroll in the program if eligible.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants interested / referred for the protocol = 32. The number screened = 21'}, {'type': 'PRIMARY', 'title': 'Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Attendance at CALM Sessions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}, {'units': 'Number of CALM sessions', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CALM', 'description': 'CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone\n\nCALM Intervention: The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints:\n\n* Within one week before initiating the CALM intervention therapy\n* Within one week after its completion,\n* 3 months after the CALM intervention is complete\n\n * After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 Months', 'description': 'Percent of sessions attended across all participants', 'unitOfMeasure': 'percentage of CALM sessions attended', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of CALM sessions', 'denomUnitsSelected': 'Number of CALM sessions'}, {'type': 'PRIMARY', 'title': 'Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Post-session Assessment Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}, {'units': 'Post-session surveys', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CALM', 'description': 'CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone\n\nCALM Intervention: The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints:\n\n* Within one week before initiating the CALM intervention therapy\n* Within one week after its completion,\n* 3 months after the CALM intervention is complete\n\n * After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 Months', 'description': 'Percent of post-session surveys completed by participants immediately after the intervention', 'unitOfMeasure': 'percentage of assessments completed', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Post-session surveys', 'denomUnitsSelected': 'Post-session surveys'}, {'type': 'PRIMARY', 'title': 'Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Post-intervention Assessment Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CALM', 'description': 'CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone\n\nCALM Intervention: The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints:\n\n* Within one week before initiating the CALM intervention therapy\n* Within one week after its completion,\n* 3 months after the CALM intervention is complete\n\n * After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 Months', 'description': 'Percent of post-intervention surveys completed', 'unitOfMeasure': 'percentage of assessments completed', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Benefit of Intervention in the Proof of Concept Project', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CALM', 'description': 'CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone\n\nCALM Intervention: The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints:\n\n* Within one week before initiating the CALM intervention therapy\n* Within one week after its completion,\n* 3 months after the CALM intervention is complete\n\n * After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '0.53', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 Months', 'description': 'Benefit will be assessed by participant responses to a question during the exit interview (e.g., Rate your overall benefit on a scale of 1-5).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CALM', 'description': 'CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone\n\nCALM Intervention: The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints:\n\n* Within one week before initiating the CALM intervention therapy\n* Within one week after its completion,\n* 3 months after the CALM intervention is complete\n\n * After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CALM', 'description': 'CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone\n\nCALM Intervention: The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints:\n\n* Within one week before initiating the CALM intervention therapy\n* Within one week after its completion,\n* 3 months after the CALM intervention is complete\n\n * After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Two participants declined to provide DOB'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-07', 'size': 301443, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-04T14:18', 'hasProtocol': True}, {'date': '2022-01-07', 'size': 169593, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-08T11:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2021-08-26', 'resultsFirstSubmitDate': '2024-11-05', 'studyFirstSubmitQcDate': '2021-10-07', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-20', 'studyFirstPostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains', 'timeFrame': '4 Months', 'description': 'At the exit interview, participants will be asked to rate the applicability of the four CALM domains on a Likert Scale from 1 (not applicable) to 5 (very applicable). The four CALM domains are as follows: Domain 1) represents symptom management and communication with healthcare providers, Domain 2) reflects changes in personal relationships, Domain 3) sense of meaning and purpose, and Domain 4) the future, hope and mortality. Higher scores mean greater applicability.'}, {'measure': 'Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Participant Screening, Eligibility, and Consent.', 'timeFrame': '12 months', 'description': 'Determine how many patients consent to screening after referral to the program, how many patients are eligible for the program after being screened, and how many consent/enroll in the program if eligible.'}, {'measure': 'Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Attendance at CALM Sessions', 'timeFrame': '3 Months', 'description': 'Percent of sessions attended across all participants'}, {'measure': 'Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Post-session Assessment Completion', 'timeFrame': '3 Months', 'description': 'Percent of post-session surveys completed by participants immediately after the intervention'}, {'measure': 'Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Post-intervention Assessment Completion', 'timeFrame': '3 Months', 'description': 'Percent of post-intervention surveys completed'}, {'measure': 'Benefit of Intervention in the Proof of Concept Project', 'timeFrame': '4 Months', 'description': 'Benefit will be assessed by participant responses to a question during the exit interview (e.g., Rate your overall benefit on a scale of 1-5).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bMET', 'CALM', 'Service Members', 'Veterans'], 'conditions': ['Cancer Metastatic to Brain', 'Brain Metastases, Adult']}, 'referencesModule': {'references': [{'pmid': '40110068', 'type': 'DERIVED', 'citation': 'Loughan AR, Lanoye A, Willis K, Braun SE, Davies A, Rodin G, Thacker L, Fox A, Kleva C, Zarrella G, Mazzeo S, Svikis D, Swartz L. Managing Cancer and Living Meaningfully in adults with brain metastases: A NIH ORBIT model phase II feasibility and proof-of-concept trial. Neurooncol Pract. 2024 Oct 15;12(2):271-280. doi: 10.1093/nop/npae097. eCollection 2025 Apr.'}]}, 'descriptionModule': {'briefSummary': 'To identify potential adaptations of the managing cancer and living meaningfully (CALM) intervention that will be required for service members, Veterans, their beneficiaries, and civilian cancer metastasis to the brain (bMET) populations.', 'detailedDescription': 'Single-arm, mixed-methods, Phase IIa, proof-of-concept trial to inform CALM adaptations for service members (SMs), Veterans, their beneficiaries, and civilians with bMET.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of brain metastasis (bMET) confirmed via medical records, radiography or histopathology\n* At least 2 weeks post-surgical cranial resection or cranial biopsy (if applicable)\n* Score \\> 20 on the TICS\n* Report elevated depression (PHQ-9 score ≥ 10) OR death anxiety symptoms (DADDS score ≥ 15)\n* Ability to read, speak, and understand English\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Major communication difficulties, which would prohibit psychotherapeutic interaction\n* Inability to meet with interventionist via an electronic device for telehealth intervention sessions\n* Inability to understand and provide informed consent\n* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the participant's risk"}, 'identificationModule': {'nctId': 'NCT05087095', 'briefTitle': 'Managing Distress in Malignant Brain Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Managing Distress in Malignant Brain Cancer', 'orgStudyIdInfo': {'id': 'MCC-21-18040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CALM', 'description': 'CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone', 'interventionNames': ['Behavioral: CALM Intervention']}], 'interventions': [{'name': 'CALM Intervention', 'type': 'BEHAVIORAL', 'description': 'The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints:\n\n* Within one week before initiating the CALM intervention therapy\n* Within one week after its completion,\n* 3 months after the CALM intervention is complete\n\n * After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components', 'armGroupLabels': ['CALM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Ashlee Loughan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share individual participant data (IPD) to other researchers at this time.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}