Back on My Feet: Emotional Recovery From Fall Injury | NCT01998945

Studies
Back on My Feet: Emotional Recovery From Fall Injury

NCT01998945

Sponsor

Weill Medical College of Cornell University

Status

Completed

Last Update Posted

Aug 16, 2016Estimated

Enrollment

22Actual

Phase

Phase 1Phase 2

Conditions

Posttraumatic Stress Disorder
Subsyndromal Posttraumatic Stress Disorder
Fear of Falling

Interventions

Exposure-based Cognitive Behavioral Therapy
Relaxation Training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
K23MH090244	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Mar 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Nov 22, 2013

First Submission Date that Met QC Criteria

Nov 30, 2013

First Posted Date

Dec 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2016

Last Update Posted Date

Aug 16, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nimali Jayasinghe, Assistant Professor of Psychology, Weill Medical College of Cornell UniversityPrincipal Investigator

Lead Sponsor

Weill Medical College of Cornell UniversityOTHER

Collaborators

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exposure-based Cognitive Behavioral Therapy (ET)	Experimental	Participants will receive exposure-based cognitive behavioral therapy	Behavioral: Exposure-based Cognitive Behavioral Therapy
Relaxation Training (RT)	Active Comparator	Participants will receive relaxation training	Behavioral: Relaxation Training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nimali Jayasinghe, PhD	Weill Medical College of Cornell University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Weill Cornell Medical College		New York	New York	10065	United States

Condition Browse Module

MeSH Terms

ID	Term
D013313	Stress Disorders, Post-Traumatic
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012064	Relaxation Therapy

Ancestor Terms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D001521	Behavior Therapy

Browse Leaves

Not provided

Browse Branches

Not provided