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Intervention for Anxiety After Falls

This study is currently recruiting participants.
Verified September 2012 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Nimali Jayasinghe, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01268657
First received: December 29, 2010
Last updated: September 4, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Posttraumatic Stress Disorder (PTSD)
Specific Phobia
Anxiety
 Behavioral: Education
Behavioral: Relaxation Training
Behavioral: Cognitive Restructuring
Behavioral: Behavioral Activation
Behavioral: Exposure
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intervention for Disabling Anxiety in Older Adults Injured by Falls

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: January 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavioral Exposure Therapy Behavioral: Education
Learning about anxiety
Other Name: 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 Name: Increasing physical activity
Behavioral: Exposure
Coaching in how to confront avoided thoughts, situations, and people)
Other Names:
  • Imaginal exposure
  • In vivo exposure

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268657

Contacts
Contact: Nimali Jayasinghe, PhD 212-821-0728 nij2001@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Principal Investigator: Nimali Jayasinghe, PhD            
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 in Clinical Psychiatry, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01268657     History of Changes
Other Study ID Numbers: K23 MH 09244
Study First Received: December 29, 2010
Last Updated: September 4, 2012
Health Authority: United States: Federal Government

Keywords provided by Weill Medical College of Cornell University:
PTSD
Fear of Falling
Older Adults
Injurious Falls
Exposure Therapy

Additional relevant MeSH terms:
Anxiety Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Phobic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013