Back on My Feet: Emotional Recovery From Fall Injury

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.

Study Overview

• Status: Completed
• Conditions: Fear of Falling; Posttraumatic Stress Disorder; Subsyndromal Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Exposure-based Cognitive Behavioral Therapy; Behavioral: Relaxation Training

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline clinician-rated PTSD at 6 weeks	Baseline, Week 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline fear of falling at 6 weeks	Baseline, Week 6
Change from baseline depression at 6 weeks	Baseline, Week 6
Change from baseline anxiety at 6 weeks	Baseline, Week 6
Change from baseline self-reported PTSD at 6 weeks	Baseline, Week 6

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Nimali Jayasinghe, PhD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: November 30, 2013
• First Posted (Estimate): December 3, 2013

Study Record Updates

• Last Update Posted (Estimate): August 16, 2016
• Last Update Submitted That Met QC Criteria: August 13, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Anxiety; Cognitive behavioral therapy; Older Adults; Posttraumatic Stress; Exposure therapy; Relaxation Training; Fall Injury
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 1306014003; K23MH090244 (U.S. NIH Grant/Contract)