Exposure Therapy for Fear of Falling in Older Adults

Phase 2

Completed

• Conditions: Fear of Falling
• Interventions: Behavioral: Activity, Balance, Learning, and Exposure; Behavioral: Fall prevention education

• Registration Number: NCT01609322
• Lead Sponsor: University of California, San Diego

Brief Summary

This project aims to test the efficacy of an in-home intervention, "Activity, Balance, Learning, and Exposure" (ABLE), which integrates exposure therapy with cognitive restructuring, exercise, and home safety evaluation for older adults with excessive fear of falling. The intervention will be conducted by a licensed physical therapist. A control intervention will be conducted by a health educator. The specific aims of the study are to test the feasibility, acceptability, tolerability, and safety of the ABLE intervention.

Detailed Description

Approximately 7-14% of older adults living independently in the community, including more than 5% of those who have never experienced a fall, experience moderate to severe fear of falling. Fear of falling leads to decreased physical activity, disability, loss of independence, depression, anxiety, reduced social engagement, and poor quality of life. It is also a major independent risk factor for falls.

Interventions targeting fear of falling, typically delivered in groups and incorporating cognitive restructuring, education, and exercise, have been shown to increase fall-related self-efficacy. Avoidance is resistant to treatment, however, and more than one-third of patients enrolled in these interventions drop out. Factors associated with attrition include high levels of fear and avoidance, indicating that the individuals most in need of such programs are those most likely to withdraw prematurely. These data suggest that avoidance should be targeted in treatment, and that interventions should be designed to reach very fearful individuals who are most likely to drop out of traditional fear of falling programs.

Participation in this study will last up to 8 months. Participants will be randomly assigned to receive either the ABLE intervention or an education control condition. The control condition will consist of in-person education about falls to control for the time and attention provided in the ABLE arm.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-05-30
• Study First Posted: 2012-05-31
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-19
• Last Update Posted: 2013-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age 65 years old or older.
2. Severe fear as measured by a brief FES-I score > or = 13.
3. Low to moderate actual risk of falls as set out in Lamb et al. (2008).
4. Distress or functional impairment due to fear of falling.
5. Approval from the patient's primary health care provider.

Exclusion Criteria

1. Medical condition that would interfere with the safe conduct of the intervention or compromise study participation.
2. Bedbound, wheelchair-dependent, paralyzed in the lower extremities, or requiring the assistance of another person to transfer, walk, or perform intervention exercises within the home.
3. Dementia or cognitive impairment as measured by a score above 10 on the Blessed Orientation Memory Test.
4. Corrected visual acuity < 20/60.
5. Current participation in psychotherapy or professional rehabilitation services (PT, OT) or in the process of being referred or evaluated for such services. Patients who develop a need for such services during their participation will complete an assessment prior to commencing the outside therapy but will be allowed to continue in the study.
6. Active suicidal ideation
7. Lifetime diagnosis of bipolar I or II disorder or any psychotic disorder.
8. Alcohol or other substance abuse or dependence within six months.
9. Psychosocial factors that would compromise study participation (e.g. homelessness, no telephone).
10. History of osteoporotic fracture.
11. Experiencing 3 or more falls in the past year.
12. Body Mass Index of 17.0 or under.
13. Significant orthostasis, defined as a 20 point or greater difference between seated and standing blood pressure, either systolic or diastolic.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Activity, Balance, Learning, and Exposure	Activity, Balance, Learning, and Exposure	Intervention combining medication review, exercise, home safety evaluation, and exposure therapy.
Education about falls	Fall prevention education	In-person education about falls with a health educator.

Primary Outcome Measures

Name	Time	Method
Fear of falling	2 months (primary)	Fear of Falling will be measured using the Falls Efficacy Scale - International (FES-I), a version of the most widely used measure of falls self-efficacy. Assessments are performed at baseline, 1 month, 2 months (end of intervention - primary outcome point). We will also collect data at 5 months (3 month follow-up) and 8 months (6 month follow-up).
Activity avoidance	2 months (primary)	Activity avoidance will be assessed using a modified version of the Activity Card Sort, a set of photographs of older adults engaged in various activities that is used in rehabilitation settings. Assessments are performed at baseline, 1 month, 2 months (end of intervention - primary outcome point), 5 months (3 month follow-up), and 8 months (6 month follow-up).

Secondary Outcome Measures

Name	Time	Method
Agoraphobic Avoidance	2 months (primary)	Agoraphobic avoidance will be measured using the 5-item agoraphobia subscale of the Fear Questionaire (FQ).
Post Traumatic Stress Disorder Symptoms	2 months (primary)	Post Traumatic Stress Disorder (PTSD) symptoms will be measured with the 6-item abbreviated form of the PTSD Checklist (PCL).
Physical Performance	2 months (primary)	Physical performance will be measured using the Short Physical Performance Battery (SPPB), which includes measured of balance, walking, and lower body strength.
Physical activity - self-report	2 months (primary)	Self-reported physical activity will be assessed with the Physical Activities Scale for the Elderly (PASE).
Physical activity	2 months	Accelerometers will also be used to measure physical activity. Patients in the study will wear an Actigraph battery-operated activity monitor worn around the waist to measure physical activity continuously during waking hours. Assessment will occur before and after the intervention.
Quality of Life	2 months (primary)	Quality of life will be measured with the Quality of Life Inventory (QOLI).
Depressive and Anxiety symptoms	2 months (primary)	Depressive and anxiety symptoms will be assessed with the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report measure with subscales assessing depressive and anxiety symptoms that does not include somatic items such as fatigue that can be associated with aging or medical conditions rather than psychiatric disorders.
Fear of Falling	2 months (primary)	Fear of falling will be measured using the Falling Questionaire, a 15-item survey assessing attitudes towards falling.
Avoidance	2 months (primary)	Avoidance of activities will be measured using the Fear of Falling Avoidance-Behavior Questionaire (FFABQ), a 14-item measure to assess avoidance behaviors.
Falls	2 months (primary)	Recorded on fall diaries provided to investigators throughout the 2-month intervention and 6-month follow-up period.

Trial Locations

Locations (1)

University of California San Diego; 🇺🇸 San Diego, California, United States