We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Intervention for Anxiety After Falls

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01268657
Recruitment Status : Completed
First Posted : December 31, 2010
Last Update Posted : August 16, 2016
Information provided by (Responsible Party):

Study Description
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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intervention for Disabling Anxiety in Older Adults Injured by Falls
Study Start Date : January 2011
Primary Completion Date : November 2013
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Falls
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   65 Years to 105 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268657

United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Principal Investigator: Nimali Jayasinghe, PhD Weill Medical College of Cornell University
More Information

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
First Posted: December 31, 2010    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016

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

Additional relevant MeSH terms:
Anxiety Disorders
Stress Disorders, Post-Traumatic
Mental Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders