Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
22 participants
INTERVENTIONAL
2013-12-31
2015-09-30
Brief Summary
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Detailed Description
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Our previous study adapted a well-researched anxiety treatment, Exposure-based Cognitive Behavioral Therapy (ET), for older adults diagnosed with full posttraumatic stress disorder (PTSD), subsyndromal PTSD, or fear of falling after fall injury. The approach was well-accepted by subjects and they reported both reductions in anxiety and having more fully returned to normal living immediately after the treatment and then three months later.
The purpose of this pilot study is to compare ET to another active treatment, Relaxation Training (RT). Both study treatments will consist of eight home-based sessions. ET consists of education about anxiety, relaxation training, managing distressing thoughts, healthy routine, and confronting avoided memories and situations. RT consists of techniques to ease bodily tension.
Twenty-four subjects will be randomly assigned to one of the two treatment groups. The study will compare how subjects in each group improve on outcomes such as diagnosis, anxiety severity, and quality of life over the course of treatment, and at three- and six-month follow-up.
The findings will provide the basis for larger future studies.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Exposure-based Cognitive Behavioral Therapy (ET)
Participants will receive exposure-based cognitive behavioral therapy
Exposure-based Cognitive Behavioral Therapy
Eight 75-minute, in-home sessions delivered twice weekly for 4 weeks of exposure-based cognitive behavioral therapy, a time-limited treatment that focuses on confronting avoided memories and situations and identifying and managing distressing thoughts.
Relaxation Training (RT)
Participants will receive relaxation training
Relaxation Training
Eight 75-minute, in-home sessions delivered twice weekly for 4 weeks of Relaxation Training, that focus on muscle relaxation and diaphragmatic breathing to address the physical symptoms of anxiety.
Interventions
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Exposure-based Cognitive Behavioral Therapy
Eight 75-minute, in-home sessions delivered twice weekly for 4 weeks of exposure-based cognitive behavioral therapy, a time-limited treatment that focuses on confronting avoided memories and situations and identifying and managing distressing thoughts.
Relaxation Training
Eight 75-minute, in-home sessions delivered twice weekly for 4 weeks of Relaxation Training, that focus on muscle relaxation and diaphragmatic breathing to address the physical symptoms of anxiety.
Eligibility Criteria
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Inclusion Criteria
* Fall accident requiring emergency room or inpatient hospital medical care with return home within past nine months
* Community dwelling
* Able to ambulate independently or with an assistive device
* English-speaking
* Diagnosis of PTSD, subsyndromal PTSD, or Fear of Falling (determined by interview)
Exclusion Criteria
* Serious or terminal illness
* Aphasia
* Current substance abuse
* Lifetime history of psychotic disorder and/or bipolar disorder
* Active suicidal or homicidal ideation
* Prescription psychotropic medication begun \< 6 weeks
60 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Weill Medical College of Cornell University
OTHER
Responsible Party
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Nimali Jayasinghe
Assistant Professor of Psychology
Principal Investigators
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Nimali Jayasinghe, PhD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Weill Cornell Medical College
New York, New York, United States
Countries
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Other Identifiers
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1306014003
Identifier Type: -
Identifier Source: org_study_id
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