Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-29 @ 9:46 PM
Study NCT ID:
NCT01268657
Status:
COMPLETED
Last Update Posted:
2016-08-16
First Post:
2010-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention for Anxiety After Falls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'C562465', 'term': 'Phobia, Specific'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D000099024', 'term': 'Mindfulness-Based Stress Reduction'}, {'id': 'D000088686', 'term': 'Cognitive Restructuring'}, {'id': 'D007171', 'term': 'Implosive Therapy'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D003887', 'term': 'Desensitization, Psychologic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-13', 'studyFirstSubmitDate': '2010-12-29', 'studyFirstSubmitQcDate': '2010-12-29', 'lastUpdatePostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Clinician Administered PTSD Scale (CAPS) and Survey of Activities and Fear of Falling in the Elderly (SAFE) will be primary outcomes.', 'timeFrame': 'At initial assessment, following completion of intervention, and 3 months after completion of intervention'}], 'secondaryOutcomes': [{'measure': 'Beck Anxiety Inventory, Beck Depression Inventory, Reintegration to Normal Living, Health Related Quality of Life, and other measures will be included.', 'timeFrame': 'At initial assessment, following completion of intervention, and 3 months after completion of intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PTSD', 'Fear of Falling', 'Older Adults', 'Injurious Falls', 'Exposure Therapy'], 'conditions': ['Posttraumatic Stress Disorder (PTSD)', 'Specific Phobia', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a brief intervention for disabling anxiety is practical to conduct and beneficial for older adults injured by falls.', 'detailedDescription': 'Falls are the most commonly occurring cause of traumatic injury among older adults. For many, the consequences include reduced mobility, difficulty performing basic self-care, social isolation, deteriorating health, or even death. Most interventions for falls do not address anxiety in the aftermath of falling.\n\nAfter an initial study assessment, participants will complete 8 home-based sessions of a Cognitive-Behavioral therapy (CBT). The sessions will be led by a study clinician who will cover the 5 intervention components:(a) education (learning about anxiety and the rationale for treatment); (b) relaxation training (learning skills to reduce tension); (c) cognitive restructuring (learning skills needed to cope better with distressing thoughts); (d) behavioral activation (learning to initiate healthy activity); and (e) exposure (coaching in how to confront avoided thoughts, situations, and people).\n\nParticipants will also complete assessments following completion of the intervention and 3 months after completion of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> or = 65 years\n* English-speaking\n* injured due to fall\n* hospitalized\n* returned home \\< or = 3 months\n* ambulatory\n* full or subsyndromal PTSD or Fear of Falling\n* residing in one of the five boroughs of New York City\n\nExclusion Criteria:\n\n* Inability to understand assessment questions\n* Marked cognitive impairment\n* Dementia\n* Schizophrenia\n* Bipolar Disorder\n* Depression with psychotic features\n* Delusional Disorder\n* Substance Use Disorder or Dependence\n* Active suicidal ideation, intent, or plan\n* Active homicidal ideation, intent or plan\n* Aphasia\n* Acute or severe medical illness or life expectancy \\< 6 months\n* Initiated psychotropic medications \\< 6 weeks prior\n* Initiated mental health treatment \\< 6 weeks prior\n* Psychosocial factors that would compromise study participation (such as not having a telephone)'}, 'identificationModule': {'nctId': 'NCT01268657', 'briefTitle': 'Intervention for Anxiety After Falls', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Intervention for Disabling Anxiety in Older Adults Injured by Falls', 'orgStudyIdInfo': {'id': 'K23 MH 09244'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavioral Exposure Therapy', 'interventionNames': ['Behavioral: Education', 'Behavioral: Relaxation Training', 'Behavioral: Cognitive Restructuring', 'Behavioral: Behavioral Activation', 'Behavioral: Exposure']}], 'interventions': [{'name': 'Education', 'type': 'BEHAVIORAL', 'otherNames': ['Psychoeducation'], 'description': 'Learning about anxiety', 'armGroupLabels': ['Cognitive Behavioral Exposure Therapy']}, {'name': 'Relaxation Training', 'type': 'BEHAVIORAL', 'otherNames': ['Relaxation', 'Stress Reduction', 'Stress Reduction Training'], 'description': 'Learning skills to reduce tension', 'armGroupLabels': ['Cognitive Behavioral Exposure Therapy']}, {'name': 'Cognitive Restructuring', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive Reframing', 'Positive self-talk'], 'description': 'Learning skills needed to cope better with distressing thoughts', 'armGroupLabels': ['Cognitive Behavioral Exposure Therapy']}, {'name': 'Behavioral Activation', 'type': 'BEHAVIORAL', 'otherNames': ['Increasing physical activity'], 'description': 'Learning to initiate healthy activity', 'armGroupLabels': ['Cognitive Behavioral Exposure Therapy']}, {'name': 'Exposure', 'type': 'BEHAVIORAL', 'otherNames': ['Imaginal exposure', 'In vivo exposure'], 'description': 'Coaching in how to confront avoided thoughts, situations, and people)', 'armGroupLabels': ['Cognitive Behavioral Exposure Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Nimali Jayasinghe, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Psychology in Clinical Psychiatry', 'investigatorFullName': 'Nimali Jayasinghe', 'investigatorAffiliation': 'Weill Medical College of Cornell University'}}}}