Clinical trial NCT01998945: Back on My Feet: Emotional Recovery From Fall Injury
Official title: Back on My Feet: Emotional Recovery From Fall Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: 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
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-12-03
Enrollment: 22
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline clinician-rated PTSD at 6 weeks
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Change from baseline fear of falling at 6 weeks
timeFrame: Baseline, Week 6
measure: Change from baseline depression at 6 weeks
timeFrame: Baseline, Week 6
measure: Change from baseline anxiety at 6 weeks
timeFrame: Baseline, Week 6
measure: Change from baseline self-reported PTSD at 6 weeks
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Nimali Jayasinghe, PhD
role: PRINCIPAL_INVESTIGATOR
References: