Skip to main content
OpenTrials
Completed

NCT Number: NCT01998945

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Posttraumatic Stress Disorder Anxiety Disorders Fear of Falling Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Subsyndromal Posttraumatic Stress Disorder Trauma and Stressor Related Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Weill Cornell Medical College

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposure-based Cognitive Behavioral Therapy

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Change from baseline clinician-rated PTSD at 6 weeks

    Time frame: Baseline, Week 6

Secondary outcomes

  1. Change from baseline fear of falling at 6 weeks

    Time frame: Baseline, Week 6

  2. Change from baseline depression at 6 weeks

    Time frame: Baseline, Week 6

  3. Change from baseline anxiety at 6 weeks

    Time frame: Baseline, Week 6

  4. Change from baseline self-reported PTSD at 6 weeks

    Time frame: Baseline, Week 6

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 3, 2013
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.