Exposure Therapy for Fear of Falling in Older Adults

Fear of Falling Clinical Trial

Official title:

Exposure Therapy for Fear of Falling in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609322
• Other study ID #: R34MH086668
• Secondary ID: R34MH086668
• Status: Completed
• Phase: Phase 2
• First received: May 29, 2012
• Last updated: December 19, 2013
• Start date: August 2010
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fear of Falling

Intervention

Behavioral:
• Activity, Balance, Learning, and Exposure
An in-home intervention that integrates exposure therapy with cognitive restructuring, exercise, and a home safety evaluation.
• Fall prevention education
In-home, individual sessions with a health educator regarding fall prevention

Locations

Country	Name	City	State
United States	University of California San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fear of falling	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).	2 months (primary)	No
Primary	Activity avoidance	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).	2 months (primary)	No
Secondary	Physical activity - self-report	Self-reported physical activity will be assessed with the Physical Activities Scale for the Elderly (PASE).	2 months (primary)	No
Secondary	Physical activity	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.	2 months	No
Secondary	Physical Performance	Physical performance will be measured using the Short Physical Performance Battery (SPPB), which includes measured of balance, walking, and lower body strength.	2 months (primary)	No
Secondary	Quality of Life	Quality of life will be measured with the Quality of Life Inventory (QOLI).	2 months (primary)	No
Secondary	Depressive and Anxiety symptoms	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.	2 months (primary)	No
Secondary	Agoraphobic Avoidance	Agoraphobic avoidance will be measured using the 5-item agoraphobia subscale of the Fear Questionaire (FQ).	2 months (primary)	No
Secondary	Post Traumatic Stress Disorder Symptoms	Post Traumatic Stress Disorder (PTSD) symptoms will be measured with the 6-item abbreviated form of the PTSD Checklist (PCL).	2 months (primary)	No
Secondary	Fear of Falling	Fear of falling will be measured using the Falling Questionaire, a 15-item survey assessing attitudes towards falling.	2 months (primary)	No
Secondary	Avoidance	Avoidance of activities will be measured using the Fear of Falling Avoidance-Behavior Questionaire (FFABQ), a 14-item measure to assess avoidance behaviors.	2 months (primary)	No
Secondary	Falls	Recorded on fall diaries provided to investigators throughout the 2-month intervention and 6-month follow-up period.	2 months (primary)	Yes