Intervention for Anxiety After Falls | NCT01268657

Studies
Intervention for Anxiety After Falls

NCT01268657

Sponsor

Weill Medical College of Cornell University

Status

Completed

Last Update Posted

Aug 16, 2016Estimated

Enrollment

23Actual

Phase

Phase 1

Conditions

Posttraumatic Stress Disorder (PTSD)
Specific Phobia
Anxiety

Interventions

Education
Relaxation Training
Cognitive Restructuring
Behavioral Activation
Exposure

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

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

Jan 2011

Primary Completion Date

Nov 2013Actual

Completion Date

Feb 2014Actual

First Submitted Date

Dec 29, 2010

First Submission Date that Met QC Criteria

Dec 29, 2010

First Posted Date

Dec 31, 2010Estimated

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 in Clinical Psychiatry, Weill Medical College of Cornell UniversityPrincipal Investigator

Lead Sponsor

Weill Medical College of Cornell UniversityOTHER

Collaborators

Not provided

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

The purpose of this study is to determine whether a brief intervention for disabling anxiety is practical to conduct and beneficial for older adults injured by falls.

Detailed Description

Falls are the most commonly occurring cause of traumatic injury among older adults. For many, the consequences include reduced mobility, difficulty performing basic self-care, social isolation, deteriorating health, or even death. Most interventions for falls do not address anxiety in the aftermath of falling.

After an initial study assessment, participants will complete 8 home-based sessions of a Cognitive-Behavioral therapy (CBT). The sessions will be led by a study clinician who will cover the 5 intervention components:(a) education (learning about anxiety and the rationale for treatment); (b) relaxation training (learning skills to reduce tension); (c) cognitive restructuring (learning skills needed to cope better with distressing thoughts); (d) behavioral activation (learning to initiate healthy activity); and (e) exposure (coaching in how to confront avoided thoughts, situations, and people).

Participants will also complete assessments following completion of the intervention and 3 months after completion of the intervention.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cognitive Behavioral Exposure Therapy	Experimental		Behavioral: Education Behavioral: Relaxation Training Behavioral: Cognitive Restructuring Behavioral: Behavioral Activation Behavioral: Exposure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Education	Behavioral	Learning about anxiety	Cognitive Behavioral Exposure Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Clinician Administered PTSD Scale (CAPS) and Survey of Activities and Fear of Falling in the Elderly (SAFE) will be primary outcomes.		At initial assessment, following completion of intervention, and 3 months after completion of intervention

Secondary Outcomes

Measure	Description	Time Frame
Beck Anxiety Inventory, Beck Depression Inventory, Reintegration to Normal Living, Health Related Quality of Life, and other measures will be included.		At initial assessment, following completion of intervention, and 3 months after completion of intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age > or = 65 years
English-speaking
injured due to fall
hospitalized
returned home < or = 3 months
ambulatory
full or subsyndromal PTSD or Fear of Falling
residing in one of the five boroughs of New York City

Exclusion Criteria:

Inability to understand assessment questions
Marked cognitive impairment
Dementia
Schizophrenia
Bipolar Disorder
Depression with psychotic features
Delusional Disorder
Substance Use Disorder or Dependence
Active suicidal ideation, intent, or plan
Active homicidal ideation, intent or plan
Aphasia
Acute or severe medical illness or life expectancy < 6 months
Initiated psychotropic medications < 6 weeks prior
Initiated mental health treatment < 6 weeks prior
Psychosocial factors that would compromise study participation (such as not having a telephone)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

105 Years

Standard Ages

Older 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
C562465	Phobia, Specific
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
D004522	Educational Status
D012064	Relaxation Therapy
D000099024	Mindfulness-Based Stress Reduction
D000088686	Cognitive Restructuring
D007171	Implosive Therapy

Ancestor Terms

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics
D026441	Mind-Body Therapies
D000529	Complementary Therapies

Browse Leaves

Not provided

Browse Branches

Not provided