Intervention for Anxiety After Falls

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intervention for Disabling Anxiety in Older Adults Injured by Falls

Conditions
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Posttraumatic Stress Disorder (PTSD), Specific Phobia, Anxiety

Intervention / Treatment
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* Behavioral: Education
* Behavioral: Relaxation Training
* Behavioral: Cognitive Restructuring
* Behavioral: Behavioral Activation
* Behavioral: Exposure


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Fear of Falling, Older Adults, Injurious Falls, Exposure Therapy