Exposure Therapy for Fear of Falling in Older Adults

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Julie Wetherell, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01609322
First received: May 29, 2012
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Fear of Falling
Behavioral: Activity, Balance, Learning, and Exposure
Behavioral: Fall prevention education
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exposure Therapy for Fear of Falling in Older Adults

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Fear of falling [ Time Frame: 2 months (primary) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 months (primary) ] [ Designated as safety issue: No ]
    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:
  • Physical activity - self-report [ Time Frame: 2 months (primary) ] [ Designated as safety issue: No ]
    Self-reported physical activity will be assessed with the Physical Activities Scale for the Elderly (PASE).

  • Physical activity [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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.

  • Physical Performance [ Time Frame: 2 months (primary) ] [ Designated as safety issue: No ]
    Physical performance will be measured using the Short Physical Performance Battery (SPPB), which includes measured of balance, walking, and lower body strength.

  • Quality of Life [ Time Frame: 2 months (primary) ] [ Designated as safety issue: No ]
    Quality of life will be measured with the Quality of Life Inventory (QOLI).

  • Depressive and Anxiety symptoms [ Time Frame: 2 months (primary) ] [ Designated as safety issue: No ]
    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.

  • Agoraphobic Avoidance [ Time Frame: 2 months (primary) ] [ Designated as safety issue: No ]
    Agoraphobic avoidance will be measured using the 5-item agoraphobia subscale of the Fear Questionaire (FQ).

  • Post Traumatic Stress Disorder Symptoms [ Time Frame: 2 months (primary) ] [ Designated as safety issue: No ]
    Post Traumatic Stress Disorder (PTSD) symptoms will be measured with the 6-item abbreviated form of the PTSD Checklist (PCL).

  • Fear of Falling [ Time Frame: 2 months (primary) ] [ Designated as safety issue: No ]
    Fear of falling will be measured using the Falling Questionaire, a 15-item survey assessing attitudes towards falling.

  • Avoidance [ Time Frame: 2 months (primary) ] [ Designated as safety issue: No ]
    Avoidance of activities will be measured using the Fear of Falling Avoidance-Behavior Questionaire (FFABQ), a 14-item measure to assess avoidance behaviors.

  • Falls [ Time Frame: 2 months (primary) ] [ Designated as safety issue: Yes ]
    Recorded on fall diaries provided to investigators throughout the 2-month intervention and 6-month follow-up period.


Enrollment: 40
Study Start Date: August 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Education about falls
In-person education about falls with a health educator.
Behavioral: Fall prevention education
In-home, individual sessions with a health educator regarding fall prevention
Experimental: Activity, Balance, Learning, and Exposure
Intervention combining medication review, exercise, home safety evaluation, and exposure therapy.
Behavioral: Activity, Balance, Learning, and Exposure
An in-home intervention that integrates exposure therapy with cognitive restructuring, exercise, and a home safety evaluation.

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609322

Locations
United States, California
University of California San Diego
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Julie Wetherell, PhD UCSD
  More Information

No publications provided

Responsible Party: Julie Wetherell, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01609322     History of Changes
Other Study ID Numbers: R34MH086668, R34MH086668
Study First Received: May 29, 2012
Last Updated: December 19, 2013
Health Authority: United States: Federal Government

Keywords provided by University of California, San Diego:
fear of falling
agoraphobia

ClinicalTrials.gov processed this record on October 20, 2014