Intervention for Anxiety After Falls

Phase 1

Completed

• Conditions: Posttraumatic Stress Disorder (PTSD); Specific Phobia; Anxiety
• Interventions: Behavioral: Education; Behavioral: Relaxation Training; Behavioral: Cognitive Restructuring; Behavioral: Behavioral Activation; Behavioral: Exposure

• Registration Number: NCT01268657
• Lead Sponsor: Weill Medical College of Cornell University

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 Timeline

• Study First Submitted: 2010-12-29
• Study First Submitted QC: 2010-12-29
• Study First Posted: 2010-12-31
• Study Start: 2011-01
• Primary Completion: 2013-11
• Study Completion: 2014-02
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-13
• Last Update Posted: 2016-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Exposure Therapy	Education	-
Cognitive Behavioral Exposure Therapy	Behavioral Activation	-
Cognitive Behavioral Exposure Therapy	Cognitive Restructuring	-
Cognitive Behavioral Exposure Therapy	Relaxation Training	-
Cognitive Behavioral Exposure Therapy	Exposure	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States