Clinical trial NCT01609322: Exposure Therapy for Fear of Falling in Older Adults
Official title: Exposure Therapy for Fear of Falling in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fear of Falling
Keywords: fear of falling
agoraphobia
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fear of falling
timeFrame: 2 months (primary)
measure: Activity avoidance
timeFrame: 2 months (primary)
Secondary outcomes:
measure: Physical activity - self-report
timeFrame: 2 months (primary)
measure: Physical activity
timeFrame: 2 months
measure: Physical Performance
timeFrame: 2 months (primary)
measure: Quality of Life
timeFrame: 2 months (primary)
measure: Depressive and Anxiety symptoms
timeFrame: 2 months (primary)
measure: Agoraphobic Avoidance
timeFrame: 2 months (primary)
measure: Post Traumatic Stress Disorder Symptoms
timeFrame: 2 months (primary)
measure: Fear of Falling
timeFrame: 2 months (primary)
measure: Avoidance
timeFrame: 2 months (primary)
measure: Falls
timeFrame: 2 months (primary)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: UCSD
name: Julie Wetherell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wetherell JL, Bower ES, Johnson K, Chang DG, Ward SR, Petkus AJ. Integrated Exposure Therapy and Exercise Reduces Fear of Falling and Avoidance in Older Adults: A Randomized Pilot Study. Am J Geriatr Psychiatry. 2018 Aug;26(8):849-859. doi: 10.1016/j.jagp.2018.04.001. Epub 2018 Apr 12.