A Phase 1/2 interventional study of Exposure-based Cognitive Behavioral Therapy and Relaxation Training in Posttraumatic Stress Disorder, Subsyndromal Posttraumatic Stress Disorder and Fear of Falling, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2016-08-16.
Sponsored by Weill Medical College of Cornell University · Phase 1/2, Interventional, and Treatment
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.
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.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's enrollment of 22 is below the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.
Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive exposure-based cognitive behavioral therapy
Behavioral: Exposure-based Cognitive Behavioral Therapy
Participants will receive relaxation training
Behavioral: Relaxation Training
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.
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
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University