Intervention for Anxiety After Falls

Anxiety Clinical Trial

Official title:

Intervention for Disabling Anxiety in Older Adults Injured by Falls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01268657
• Other study ID #: K23 MH 09244
• Status: Completed
• Phase: Phase 1
• First received: December 29, 2010
• Last updated: August 13, 2016
• Start date: January 2011
• Est. completion date: February 2014

Study information

• Verified date: August 2016
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 105 Years

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Posttraumatic Stress Disorder (PTSD)
• Specific Phobia
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Education
Learning about anxiety
• Relaxation Training
Learning skills to reduce tension
• Cognitive Restructuring
Learning skills needed to cope better with distressing thoughts
• Behavioral Activation
Learning to initiate healthy activity
• Exposure
Coaching in how to confront avoided thoughts, situations, and people)

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No