Intervention for Anxiety After Falls
Primary Purpose
Posttraumatic Stress Disorder (PTSD), Specific Phobia, Anxiety
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Education
Relaxation Training
Cognitive Restructuring
Behavioral Activation
Exposure
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder (PTSD) focused on measuring PTSD, Fear of Falling, Older Adults, Injurious Falls, Exposure Therapy
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)
Sites / Locations
- Weill Cornell Medical College
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive Behavioral Exposure Therapy
Arm Description
Outcomes
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.
Secondary Outcome Measures
Beck Anxiety Inventory, Beck Depression Inventory, Reintegration to Normal Living, Health Related Quality of Life, and other measures will be included.
Full Information
NCT ID
NCT01268657
First Posted
December 29, 2010
Last Updated
August 13, 2016
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT01268657
Brief Title
Intervention for Anxiety After Falls
Official Title
Intervention for Disabling Anxiety in Older Adults Injured by Falls
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder (PTSD), Specific Phobia, Anxiety
Keywords
PTSD, Fear of Falling, Older Adults, Injurious Falls, Exposure Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioral Exposure Therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Education
Other Intervention Name(s)
Psychoeducation
Intervention Description
Learning about anxiety
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Training
Other Intervention Name(s)
Relaxation, Stress Reduction, Stress Reduction Training
Intervention Description
Learning skills to reduce tension
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Restructuring
Other Intervention Name(s)
Cognitive Reframing, Positive self-talk
Intervention Description
Learning skills needed to cope better with distressing thoughts
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation
Other Intervention Name(s)
Increasing physical activity
Intervention Description
Learning to initiate healthy activity
Intervention Type
Behavioral
Intervention Name(s)
Exposure
Other Intervention Name(s)
Imaginal exposure, In vivo exposure
Intervention Description
Coaching in how to confront avoided thoughts, situations, and people)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nimali Jayasinghe, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Intervention for Anxiety After Falls
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