Intervention for Anxiety After Falls

This study is ongoing, but not recruiting participants.
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: August 19, 2013
Last verified: August 2013
  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:


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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268657

Locations
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
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: August 19, 2013
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 July 29, 2014