Back on My Feet: Emotional Recovery From Fall Injury
Primary Purpose
Posttraumatic Stress Disorder, Subsyndromal Posttraumatic Stress Disorder, Fear of Falling
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Exposure-based Cognitive Behavioral Therapy
Relaxation Training
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Exposure therapy, Cognitive behavioral therapy, Relaxation Training, Older Adults, Fall Injury, Anxiety, Posttraumatic Stress
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Weill Cornell Medical College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exposure-based Cognitive Behavioral Therapy (ET)
Relaxation Training (RT)
Arm Description
Participants will receive exposure-based cognitive behavioral therapy
Participants will receive relaxation training
Outcomes
Primary Outcome Measures
Change from baseline clinician-rated PTSD at 6 weeks
Secondary Outcome Measures
Change from baseline fear of falling at 6 weeks
Change from baseline depression at 6 weeks
Change from baseline anxiety at 6 weeks
Change from baseline self-reported PTSD at 6 weeks
Full Information
NCT ID
NCT01998945
First Posted
November 22, 2013
Last Updated
August 13, 2016
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01998945
Brief Title
Back on My Feet: Emotional Recovery From Fall Injury
Official Title
Back on My Feet: Emotional Recovery From Fall Injury
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Fall accidents can be frightening experiences that cause life-changing injuries. Each year, millions of older Americans who fall may develop disabling anxiety and related distress, functional limitations, and poor health.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Subsyndromal Posttraumatic Stress Disorder, Fear of Falling
Keywords
Exposure therapy, Cognitive behavioral therapy, Relaxation Training, Older Adults, Fall Injury, Anxiety, Posttraumatic Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exposure-based Cognitive Behavioral Therapy (ET)
Arm Type
Experimental
Arm Description
Participants will receive exposure-based cognitive behavioral therapy
Arm Title
Relaxation Training (RT)
Arm Type
Active Comparator
Arm Description
Participants will receive relaxation training
Intervention Type
Behavioral
Intervention Name(s)
Exposure-based Cognitive Behavioral Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline clinician-rated PTSD at 6 weeks
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Change from baseline fear of falling at 6 weeks
Time Frame
Baseline, Week 6
Title
Change from baseline depression at 6 weeks
Time Frame
Baseline, Week 6
Title
Change from baseline anxiety at 6 weeks
Time Frame
Baseline, Week 6
Title
Change from baseline self-reported PTSD at 6 weeks
Time Frame
Baseline, Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nimali Jayasinghe, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
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Back on My Feet: Emotional Recovery From Fall Injury
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