Back on My Feet: Emotional Recovery From Fall Injury
2 other identifiers
interventional
22
1 country
1
Brief Summary
We will compare two programs that are designed to help older adults who have had fall injuries manage anxiety and improve their level of functioning. We expect that both programs will provide some benefit, but that one will promote better management.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedFirst Posted
Study publicly available on registry
December 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedAugust 16, 2016
August 1, 2016
1.2 years
November 22, 2013
August 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline clinician-rated PTSD at 6 weeks
Baseline, Week 6
Secondary Outcomes (4)
Change from baseline fear of falling at 6 weeks
Baseline, Week 6
Change from baseline depression at 6 weeks
Baseline, Week 6
Change from baseline anxiety at 6 weeks
Baseline, Week 6
Change from baseline self-reported PTSD at 6 weeks
Baseline, Week 6
Study Arms (2)
Exposure-based Cognitive Behavioral Therapy (ET)
EXPERIMENTALParticipants will receive exposure-based cognitive behavioral therapy
Relaxation Training (RT)
ACTIVE COMPARATORParticipants will receive relaxation training
Interventions
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.
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
You may qualify if:
- Age 60 years and older
- 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)
You may not qualify if:
- Cognitive impairment
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weill Cornell Medical College
New York, New York, 10065, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nimali Jayasinghe, PhD
Weill Medical College of Cornell University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Psychology
Study Record Dates
First Submitted
November 22, 2013
First Posted
December 3, 2013
Study Start
December 1, 2013
Primary Completion
March 1, 2015
Study Completion
September 1, 2015
Last Updated
August 16, 2016
Record last verified: 2016-08