Back on My Feet: Emotional Recovery From Fall Injury

Posttraumatic Stress Disorder Clinical Trial

Official title:

Back on My Feet: Emotional Recovery From Fall Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01998945
• Other study ID #: 1306014003
• Secondary ID: K23MH090244
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 22, 2013
• Last updated: August 13, 2016
• Start date: December 2013
• Est. completion date: September 2015

Study information

• Verified date: August 2016
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Data and Safety Monitoring BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Fear of Falling
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Subsyndromal Posttraumatic Stress Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline clinician-rated PTSD at 6 weeks		Baseline, Week 6	No
Secondary	Change from baseline fear of falling at 6 weeks		Baseline, Week 6	No
Secondary	Change from baseline depression at 6 weeks		Baseline, Week 6	No
Secondary	Change from baseline anxiety at 6 weeks		Baseline, Week 6	No
Secondary	Change from baseline self-reported PTSD at 6 weeks		Baseline, Week 6	No