Back on My Feet: Emotional Recovery From Fall Injury

Phase 1

Completed

• Conditions: Fear of Falling; Posttraumatic Stress Disorder; Subsyndromal Posttraumatic Stress Disorder
• Interventions: Behavioral: Exposure-based Cognitive Behavioral Therapy; Behavioral: Relaxation Training

• Registration Number: NCT01998945
• Lead Sponsor: Weill Medical College of Cornell University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-11-30
• Study Start: 2013-12
• Study First Posted: 2013-12-03
• Primary Completion: 2015-03
• Study Completion: 2015-09
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-13
• Last Update Posted: 2016-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exposure-based Cognitive Behavioral Therapy (ET)	Exposure-based Cognitive Behavioral Therapy	Participants will receive exposure-based cognitive behavioral therapy
Relaxation Training (RT)	Relaxation Training	Participants will receive relaxation training

Primary Outcome Measures

Name	Time	Method
Change from baseline clinician-rated PTSD at 6 weeks	Baseline, Week 6

Secondary Outcome Measures

Name	Time	Method
Change from baseline self-reported PTSD at 6 weeks	Baseline, Week 6
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

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States