Exposure Therapy for Fear of Falling in Older Adults

NCT01609322 | Completed Phase 2 DMC

• 1 other identifier: R34MH086668
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fear of Falling

Keywords

fear of falling; agoraphobia

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (10)

• Physical activity - self-report

  2 months (primary)

• Physical activity

  2 months

• Physical Performance

  2 months (primary)

• Quality of Life

  2 months (primary)

• Depressive and Anxiety symptoms

  2 months (primary)

Study Arms (2)

Education about falls

ACTIVE COMPARATOR

In-person education about falls with a health educator.

Behavioral: Fall prevention education

Activity, Balance, Learning, and Exposure

EXPERIMENTAL

Intervention combining medication review, exercise, home safety evaluation, and exposure therapy.

Behavioral: Activity, Balance, Learning, and Exposure

Interventions

Activity, Balance, Learning, and Exposure BEHAVIORAL

An in-home intervention that integrates exposure therapy with cognitive restructuring, exercise, and a home safety evaluation.

Activity, Balance, Learning, and Exposure

Fall prevention education BEHAVIORAL

In-home, individual sessions with a health educator regarding fall prevention

Education about falls

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Medical condition that would interfere with the safe conduct of the intervention or compromise study participation.
• 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.
• Dementia or cognitive impairment as measured by a score above 10 on the Blessed Orientation Memory Test.
• Corrected visual acuity \< 20/60.
• 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.
• Active suicidal ideation
• Lifetime diagnosis of bipolar I or II disorder or any psychotic disorder.
• Alcohol or other substance abuse or dependence within six months.
• Psychosocial factors that would compromise study participation (e.g. homelessness, no telephone).
• History of osteoporotic fracture.
• Experiencing 3 or more falls in the past year.
• Body Mass Index of 17.0 or under.
• Significant orthostasis, defined as a 20 point or greater difference between seated and standing blood pressure, either systolic or diastolic.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California San Diego

San Diego, California, 92103, United States

Location

Related Publications (1)

• 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.

  PMID: 29754811 DERIVED

MeSH Terms

Conditions

Agoraphobia

Interventions

Exercise; Educational Status

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Socioeconomic Factors; Population Characteristics

Study Officials

• Julie Wetherell, PhD

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: May 31, 2012
• Study Start: August 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 23, 2013

Record last verified: 2013-12

Locations

US (1)