Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-01-15 @ 1:49 PM
Study NCT ID:
NCT01702220
Status:
COMPLETED
Last Update Posted:
2016-01-12
First Post:
2012-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calmer Life: Testing the Effectiveness of a Treatment for Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-11', 'studyFirstSubmitDate': '2012-10-04', 'studyFirstSubmitQcDate': '2012-10-05', 'lastUpdatePostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geriatric Anxiety Inventory', 'timeFrame': '3 months'}, {'measure': 'Penn State Worry Questionnaire (PSWQ-A)', 'timeFrame': '3 months'}, {'measure': 'Generalized Anxiety Disorder-7', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire-9', 'timeFrame': '3 months'}, {'measure': 'Insomnia Severity Index', 'timeFrame': '3 months'}, {'measure': 'Late-Life Functional Disability Index', 'timeFrame': '3 months'}, {'measure': 'SF-12 Health Survey', 'timeFrame': '3 months'}, {'measure': 'Client Satisfaction Questionnaire', 'timeFrame': '3 months'}, {'measure': 'Brief RCOPE', 'timeFrame': '3 months', 'description': 'Religious coping'}, {'measure': 'Health services use', 'timeFrame': '3 months'}, {'measure': 'Use of psychotropic medication', 'timeFrame': '3 months'}, {'measure': 'Brief Multidimensional Measure of Religiousness and Spirituality', 'timeFrame': '3 months'}, {'measure': 'Satisfaction with Life Scale', 'timeFrame': '3 months'}, {'measure': 'Geriatric Depression Scale', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Generalized Anxiety Disorder', 'Geriatric'], 'conditions': ['Generalized Anxiety Disorder', 'Anxiety Disorder NOS']}, 'referencesModule': {'references': [{'pmid': '27426212', 'type': 'DERIVED', 'citation': 'Stanley MA, Wilson N, Shrestha S, Amspoker AB, Armento M, Cummings JP, Evans-Hudnall G, Wagener P, Kunik ME. Calmer Life: A Culturally Tailored Intervention for Anxiety in Underserved Older Adults. Am J Geriatr Psychiatry. 2016 Aug;24(8):648-658. doi: 10.1016/j.jagp.2016.03.008. Epub 2016 Mar 29.'}]}, 'descriptionModule': {'briefSummary': 'The overall goals of the proposed research study are to: (1) examine quantitative outcomes in a well-conducted randomized clinical trial of Calmer Life, relative to Enhanced Community Care, an information and referral intervention that represents care in a real-world community-service environment, and (2) evaluate implementation feasibility, which includes training community providers; examining program reach, engagement, acceptability, and barriers-facilitators; and preparing practical tools for replicating the program.', 'detailedDescription': "Cognitive behavioral treatment (CBT) produces positive outcomes for late-life worry/GAD in academic and primary care settings, but minorities are significantly underrepresented in clinical trials, and standard CBT poorly addresses the needs of low-income minority older adults in underserved communities. More attention needs to be given to service delivery of anxiety treatments for underserved older adults. Calmer Life (CL) is a culturally tailored, participant-centered research study that offers a skills-based intervention for late-life anxiety and includes other elements of care to meet the needs of underserved, minority older adults, including the option to integrate religion/spirituality (R/S), flexible delivery modes, and modular treatment format.\n\nParticipants will be randomly assigned to CL or Enhanced Community Care(ECC). CL and ECC will be provided by behavioral health clinicians recruited from partner organizations, psychology trainees, and other research staff over 3 months. Assessments will occur at baseline and 3 months.\n\nParticipants in the CL condition can choose up to 12 individual skill sessions, and will be recommended to complete a minimum of 6 sessions. If participants desire to incorporate R/S, an R/S assessment occurs during session 2 to help the provider understand the participant's beliefs and practices. R/S can be integrated into any of the skills learned during the intervention (e.g., deep breathing, self-statements, sleep management) or omitted entirely.\n\nParticipants in the ECC condition will receive brief biweekly check in calls to provide information about community resources (including mental health), offer emotional support, and assess symptom severity and need for crisis intervention. Emergency procedures will be followed in crisis situations. After 3 months of ECC is completed, participants in the ECC group will be offered the CL intervention.\n\nOutcome measures will be administered for participants in both groups at baseline, 1 month, and 3 months. Participants in ECC will complete measures at 6 months after completion of CL."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 50 and older\n* Principal or Co-principal diagnosis of GAD or ADNOS\n* Must speak English\n* Must have a health care or social service provider and provide written authorization to research team to communicate with their health-care or social service provider\n* Must live, work, worship, attend community functions, and/or receive health care in target geographic areas\n\nExclusion Criteria:\n\n* Active suicidal intent\n* Current psychosis\n* Mania or substance abuse within the last month\n* Cognitive impairment according to a Mini Cog screener score of 3 or lower'}, 'identificationModule': {'nctId': 'NCT01702220', 'briefTitle': 'Calmer Life: Testing the Effectiveness of a Treatment for Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Calmer Life: A Randomized Controlled Trial of a Participant-Centered Treatment for Anxiety in Low-Income, Older Adults', 'orgStudyIdInfo': {'id': 'H30928'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT', 'interventionNames': ['Behavioral: CBT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Community Care (ECC)', 'interventionNames': ['Other: ECC']}], 'interventions': [{'name': 'CBT', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive Behavior Treatment, Cognitive Behavior Therapy'], 'description': '6-12 sessions of CBT in person or over the phone', 'armGroupLabels': ['CBT']}, {'name': 'ECC', 'type': 'OTHER', 'otherNames': ['Enhanced Community Care'], 'description': '6 biweekly sessions of ECC over the telephone', 'armGroupLabels': ['Enhanced Community Care (ECC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Center for Quality of Care and Utilization Studies', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Melinda A Stanley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Retirement Research Foundation', 'class': 'OTHER'}, {'name': 'Archstone Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Melinda Stanley', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}