Trial record 10 of 118 for:    Post Traumatic Stress Disorders [CONDITION] AND NIH [SPONSOR-COLLABORATORS-CLASS] NOT NIMH [ORGANIZATION-NAME]

Back on My Feet: Emotional Recovery From Fall Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Weill Medical College of Cornell University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nimali Jayasinghe, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01998945
First received: November 22, 2013
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Posttraumatic Stress Disorder
Subsyndromal Posttraumatic Stress Disorder
Fear of Falling
Behavioral: Exposure-based Cognitive Behavioral Therapy
Behavioral: Relaxation Training
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Back on My Feet: Emotional Recovery From Fall Injury

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Change from baseline clinician-rated PTSD at 6 weeks [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline fear of falling at 6 weeks [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Change from baseline depression at 6 weeks [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Change from baseline anxiety at 6 weeks [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Change from baseline self-reported PTSD at 6 weeks [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: December 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01998945

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Nimali Jayasinghe, PhD    212-821-0728    nij2001@med.cornell.edu   
Contact: Margo A Kakoullis, PsyD    212-821-0627    mak2084@med.cornell.edu   
Principal Investigator: Nimali Jayasinghe, PhD         
Sub-Investigator: Margo A Kakoullis, PsyD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Nimali Jayasinghe, PhD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Nimali Jayasinghe, Assistant Professor of Psychology, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01998945     History of Changes
Other Study ID Numbers: 1306014003, K23MH090244
Study First Received: November 22, 2013
Last Updated: June 6, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board
United States: Federal Government

Keywords provided by Weill Medical College of Cornell University:
Exposure therapy
Cognitive behavioral therapy
Relaxation Training
Older Adults
Fall Injury
Anxiety
Posttraumatic Stress

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Wounds and Injuries
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014