Clinical trial NCT01268657: Intervention for Anxiety After Falls
Official title: Intervention for Disabling Anxiety in Older Adults Injured by Falls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Posttraumatic Stress Disorder (PTSD)
Specific Phobia
Anxiety
Keywords: PTSD
Fear of Falling
Older Adults
Injurious Falls
Exposure Therapy
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2010-12-31
Enrollment: 23
Sex: ALL
Minimum age (years): 65
Maximum age (years): 105
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: The Clinician Administered PTSD Scale (CAPS) and Survey of Activities and Fear of Falling in the Elderly (SAFE) will be primary outcomes.
timeFrame: At initial assessment, following completion of intervention, and 3 months after completion of intervention
Secondary outcomes:
measure: Beck Anxiety Inventory, Beck Depression Inventory, Reintegration to Normal Living, Health Related Quality of Life, and other measures will be included.
timeFrame: At initial assessment, following completion of intervention, and 3 months after completion of intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Nimali Jayasinghe, PhD
role: PRINCIPAL_INVESTIGATOR
References: