Fear of FallingPhase 2NCT01609322
Exposure Therapy for Fear of Falling in Older Adults
A Phase 2 study testing Activity, Balance, Learning, and Exposure and Fall prevention education in people with Fear of Falling, run by University of California, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fear of Falling
- What is being tested?
- Activity, Balance, Learning, and Exposure and Fall prevention education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92103
About this study
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.
Read the 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.
- Conditions
- Fear of Falling
- Being tested
- Activity, Balance, Learning, and Exposure, Fall prevention education
- Keywords
- fear of falling, agoraphobia
- Medical subject headings
- Agoraphobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity, Balance, Learning, and ExposureBehavioural
An in-home intervention that integrates exposure therapy with cognitive restructuring, exercise, and a home safety evaluation.
Fall prevention educationBehavioural
In-home, individual sessions with a health educator regarding fall prevention
| Study group | Role | What they receive |
|---|---|---|
| Education about falls | Active comparator | In-person education about falls with a health educator. Receives: Behavioral: Fall prevention education |
| Activity, Balance, Learning, and Exposure | Experimental | Intervention combining medication review, exercise, home safety evaluation, and exposure therapy. Receives: Behavioral: Activity, Balance, Learning, and Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 2 months (primary)
Secondary outcomes (10)
Physical activity - self-report
Self-reported physical activity will be assessed with the Physical Activities Scale for the Elderly (PASE).
Measured: 2 months (primary)
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.
Measured: 2 months
Physical Performance
Physical performance will be measured using the Short Physical Performance Battery (SPPB), which includes measured of balance, walking, and lower body strength.
Measured: 2 months (primary)
Quality of Life
Quality of life will be measured with the Quality of Life Inventory (QOLI).
Measured: 2 months (primary)
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.
Measured: 2 months (primary)
Agoraphobic Avoidance
Agoraphobic avoidance will be measured using the 5-item agoraphobia subscale of the Fear Questionaire (FQ).
Measured: 2 months (primary)
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).
Measured: 2 months (primary)
Fear of Falling
Fear of falling will be measured using the Falling Questionaire, a 15-item survey assessing attitudes towards falling.
Measured: 2 months (primary)
Avoidance
Avoidance of activities will be measured using the Fear of Falling Avoidance-Behavior Questionaire (FFABQ), a 14-item measure to assess avoidance behaviors.
Measured: 2 months (primary)
Falls
Recorded on fall diaries provided to investigators throughout the 2-month intervention and 6-month follow-up period.
Measured: 2 months (primary)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startAug 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fear of FallingStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Julie Wetherell, University of California, San Diego
- Investigators
- Julie Wetherell, PhD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609322
- Sponsor's protocol ID
- R34MH086668
- Other IDs
- R34MH086668
- Status last verified
- Dec 2013
- First submitted
- 29 May 2012
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29754811
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure Therapy for Fear of Falling in Older Adults
- ClinicalTrials.gov ID
- NCT01609322
- Acronym / sponsor ID
- R34MH086668
- Conditions
- Fear of Falling
- Keywords
- fear of falling, agoraphobia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 31 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education about falls | Active comparator | Behavioral: Fall prevention educationIn-person education about falls with a health educator. |
| Activity, Balance, Learning, and Exposure | Experimental | Behavioral: Activity, Balance, Learning, and ExposureIntervention combining medication review, exercise, home safety evaluation, and exposure therapy. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity, Balance, Learning, and ExposureAn in-home intervention that integrates exposure therapy with cognitive restructuring, exercise, and a home safety evaluation. | Behavioural | Activity, Balance, Learning, and Exposure |
| Fall prevention educationIn-home, individual sessions with a health educator regarding fall prevention | Behavioural | Education about falls |
Primary outcome
Fear of falling
Time frame: 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
Time frame: 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).
10 secondary outcomes
Physical activity - self-report
Time frame: 2 months (primary)
Physical activity
Time frame: 2 months
Physical Performance
Time frame: 2 months (primary)
Quality of Life
Time frame: 2 months (primary)
Depressive and Anxiety symptoms
Time frame: 2 months (primary)
Agoraphobic Avoidance
Time frame: 2 months (primary)
Post Traumatic Stress Disorder Symptoms
Time frame: 2 months (primary)
Fear of Falling
Time frame: 2 months (primary)
Avoidance
Time frame: 2 months (primary)
Falls
Time frame: 2 months (primary)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2013.
- Derived from this study: PubMed 29754811Wetherell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Wetherell, PhD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Activity, Balance, Learning, and Exposure and Fall prevention education in people with Fear of Falling, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of falling (time frame: 2 months (primary)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01609322, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2013.