Back on My Feet: Emotional Recovery From Fall Injury
|Posttraumatic Stress Disorder Subsyndromal Posttraumatic Stress Disorder Fear of Falling||Behavioral: Exposure-based Cognitive Behavioral Therapy Behavioral: Relaxation Training||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Back on My Feet: Emotional Recovery From Fall Injury|
- Change from baseline clinician-rated PTSD at 6 weeks [ Time Frame: Baseline, Week 6 ]
- Change from baseline fear of falling at 6 weeks [ Time Frame: Baseline, Week 6 ]
- Change from baseline depression at 6 weeks [ Time Frame: Baseline, Week 6 ]
- Change from baseline anxiety at 6 weeks [ Time Frame: Baseline, Week 6 ]
- Change from baseline self-reported PTSD at 6 weeks [ Time Frame: Baseline, Week 6 ]
|Study Start Date:||December 2013|
|Study Completion Date:||September 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Exposure-based Cognitive Behavioral Therapy (ET)
Participants will receive exposure-based cognitive behavioral therapy
Behavioral: 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.
Active Comparator: Relaxation Training (RT)
Participants will receive relaxation training
Behavioral: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01998945
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10065|
|Principal Investigator:||Nimali Jayasinghe, PhD||Weill Medical College of Cornell University|