Intervention for Disabling Anxiety in Older Adults Injured by Falls
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- The Clinician Administered PTSD Scale (CAPS) and Survey of Activities and Fear of Falling in the Elderly (SAFE) will be primary outcomes.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to 105 Years (Older Adult)
- Sex
- 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
- •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
- •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)
Arms & Interventions
Cognitive Behavioral Exposure Therapy
Intervention: Education (Behavioral)
Cognitive Behavioral Exposure Therapy
Intervention: Relaxation Training (Behavioral)
Cognitive Behavioral Exposure Therapy
Intervention: Cognitive Restructuring (Behavioral)
Cognitive Behavioral Exposure Therapy
Intervention: Behavioral Activation (Behavioral)
Cognitive Behavioral Exposure Therapy
Intervention: Exposure (Behavioral)
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Investigators
Nimali Jayasinghe
Assistant Professor of Psychology in Clinical Psychiatry
Weill Medical College of Cornell University