Intervention for Anxiety After Falls
| Tracking Information | |||||
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| First Received Date ICMJE | December 29, 2010 | ||||
| Last Updated Date | September 4, 2012 | ||||
| Start Date ICMJE | January 2011 | ||||
| Estimated Primary Completion Date | March 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The Clinician Administered PTSD Scale (CAPS) and Survey of Activities and Fear of Falling in the Elderly (SAFE) will be primary outcomes. [ Time Frame: At initial assessment, following completion of intervention, and 3 months after completion of intervention ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01268657 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Beck Anxiety Inventory, Beck Depression Inventory, Reintegration to Normal Living, Health Related Quality of Life, and other measures will be included. [ Time Frame: At initial assessment, following completion of intervention, and 3 months after completion of intervention ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intervention for Anxiety After Falls | ||||
| Official Title ICMJE | Intervention for Disabling Anxiety in Older Adults Injured by Falls | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. After 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). Participants will also complete assessments following completion of the intervention and 3 months after completion of the intervention. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | Experimental: Cognitive Behavioral Exposure Therapy
Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 32 | ||||
| Estimated Completion Date | June 2015 | ||||
| Estimated Primary Completion Date | March 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01268657 | ||||
| Other Study ID Numbers ICMJE | K23 MH 09244 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Nimali Jayasinghe, Weill Medical College of Cornell University | ||||
| Study Sponsor ICMJE | Weill Medical College of Cornell University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Weill Medical College of Cornell University | ||||
| Verification Date | September 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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