Intervention for Anxiety After Falls

August 13, 2016 updated by: Nimali Jayasinghe, Weill Medical College of Cornell University

Intervention for Disabling Anxiety in Older Adults Injured by Falls

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 105 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Behavioral Exposure Therapy
Behavioral: Education
Learning about anxiety
Other Names:
  • Psychoeducation
Behavioral: Relaxation Training
Learning skills to reduce tension
Other Names:
  • Relaxation
  • Stress Reduction
  • Stress Reduction Training
Behavioral: Cognitive Restructuring
Learning skills needed to cope better with distressing thoughts
Other Names:
  • Cognitive Reframing
  • Positive self-talk
Behavioral: Behavioral Activation
Learning to initiate healthy activity
Other Names:
  • Increasing physical activity
Behavioral: Exposure
Coaching in how to confront avoided thoughts, situations, and people)
Other Names:
  • Imaginal exposure
  • In vivo exposure

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Nimali Jayasinghe, PhD, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

December 29, 2010

First Submitted That Met QC Criteria

December 29, 2010

First Posted (Estimate)

December 31, 2010

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 13, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23 MH 09244

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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