Posttraumatic Stress Disorder (PTSD)Phase 1NCT01268657
Intervention for Anxiety After Falls
A Phase 1 study testing Education, Relaxation Training and Cognitive Restructuring in people with Posttraumatic Stress Disorder (PTSD) and Specific Phobia, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a brief intervention for disabling anxiety is practical to conduct and beneficial for older adults injured by falls. Read more about this study
- Who is it for?
- Ages 65 to 105 years
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD), Specific Phobia, Anxiety
- What is being tested?
- Education, Relaxation Training and Cognitive Restructuring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Feb 2014
- Phase
- Phase 1
- 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 to 105 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age > or = 65 years
- English-speaking
- injured due to fall
- hospitalized
- returned home < or = 3 months
- ambulatory
- full or subsyndromal PTSD or Fear of Falling
- residing in one of the five boroughs of New York City
Who cannot join
- Inability to understand assessment questions
- Marked cognitive impairment
- Dementia
- Schizophrenia
- Bipolar Disorder
- Depression with psychotic features
Show all 15Show fewer
- Delusional Disorder
- Substance Use Disorder or Dependence
- Active suicidal ideation, intent, or plan
- Active homicidal ideation, intent or plan
- Aphasia
- Acute or severe medical illness or life expectancy < 6 months
- Initiated psychotropic medications < 6 weeks prior
- Initiated mental health treatment < 6 weeks prior
- Psychosocial factors that would compromise study participation (such as not having a telephone)
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: Intervention for Disabling Anxiety in Older Adults Injured by Falls
The purpose of this study is to determine whether a brief intervention for disabling anxiety is practical to conduct and beneficial for older adults injured by falls.
Read the detailed description
Falls are the most commonly occurring cause of traumatic injury among older adults. For many, the consequences include reduced mobility, difficulty performing basic self-care, social isolation, deteriorating health, or even death. Most interventions for falls do not address anxiety in the aftermath of falling.
After an initial study assessment, participants will complete 8 home-based sessions of a Cognitive-Behavioral therapy (CBT). The sessions will be led by a study clinician who will cover the 5 intervention components:(a) education (learning about anxiety and the rationale for treatment); (b) relaxation training (learning skills to reduce tension); (c) cognitive restructuring (learning skills needed to cope better with distressing thoughts); (d) behavioral activation (learning to initiate healthy activity); and (e) exposure (coaching in how to confront avoided thoughts, situations, and people).
Participants will also complete assessments following completion of the intervention and 3 months after completion of the intervention.
- Being tested
- Education, Relaxation Training, Cognitive Restructuring, Behavioral Activation, Exposure
- Keywords
- PTSD, Fear of Falling, Older Adults, Injurious Falls, Exposure Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Phobia, Specific, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Also called Psychoeducation
Learning about anxiety
Relaxation TrainingBehavioural
Also called Relaxation, Stress Reduction, Stress Reduction Training
Learning skills to reduce tension
Cognitive RestructuringBehavioural
Also called Cognitive Reframing, Positive self-talk
Learning skills needed to cope better with distressing thoughts
Behavioral ActivationBehavioural
Also called Increasing physical activity
Learning to initiate healthy activity
ExposureBehavioural
Also called Imaginal exposure, In vivo exposure
Coaching in how to confront avoided thoughts, situations, and people)
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Exposure Therapy | Experimental | Not described Receives: Behavioral: Education; Behavioral: Relaxation Training; Behavioral: Cognitive Restructuring; Behavioral: Behavioral Activation; Behavioral: Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Clinician Administered PTSD Scale (CAPS) and Survey of Activities and Fear of Falling in the Elderly (SAFE) will be primary outcomes.
Measured: At initial assessment, following completion of intervention, and 3 months after completion of intervention
Secondary outcomes (1)
Beck Anxiety Inventory, Beck Depression Inventory, Reintegration to Normal Living, Health Related Quality of Life, and other measures will be included.
Measured: At initial assessment, following completion of intervention, and 3 months after completion of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionNov 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nimali Jayasinghe, Weill Medical College of Cornell University
- Investigators
- Nimali Jayasinghe, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268657
- Sponsor's protocol ID
- K23 MH 09244
- Status last verified
- Aug 2016
- First submitted
- 29 Dec 2010
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Disabling Anxiety in Older Adults Injured by Falls
- ClinicalTrials.gov ID
- NCT01268657
- Acronym / sponsor ID
- K23 MH 09244
- Keywords
- PTSD, Fear of Falling, Older Adults, Injurious Falls, Exposure Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 31 Dec 2010 (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.
The purpose of this study is to determine whether a brief intervention for disabling anxiety is practical to conduct and beneficial for older adults injured by falls.
Detailed description
Falls are the most commonly occurring cause of traumatic injury among older adults. For many, the consequences include reduced mobility, difficulty performing basic self-care, social isolation, deteriorating health, or even death. Most interventions for falls do not address anxiety in the aftermath of falling.
After an initial study assessment, participants will complete 8 home-based sessions of a Cognitive-Behavioral therapy (CBT). The sessions will be led by a study clinician who will cover the 5 intervention components:(a) education (learning about anxiety and the rationale for treatment); (b) relaxation training (learning skills to reduce tension); (c) cognitive restructuring (learning skills needed to cope better with distressing thoughts); (d) behavioral activation (learning to initiate healthy activity); and (e) exposure (coaching in how to confront avoided thoughts, situations, and people).
Participants will also complete assessments following completion of the intervention and 3 months after completion of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Exposure Therapy | Experimental | Behavioral: Education, Behavioral: Relaxation Training, Behavioral: Cognitive Restructuring, Behavioral: Behavioral Activation, Behavioral: Exposure |
Who may qualify
- Ages
- 65 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- age > or = 65 years
- English-speaking
- injured due to fall
- hospitalized
- returned home < or = 3 months
Key exclusion criteria (15 listed)
- Inability to understand assessment questions
- Marked cognitive impairment
- Dementia
- Schizophrenia
- Bipolar Disorder
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 |
|---|---|---|
| EducationAlso: PsychoeducationLearning about anxiety | Behavioural | Cognitive Behavioral Exposure Therapy |
| Relaxation TrainingAlso: Relaxation, Stress Reduction, Stress Reduction TrainingLearning skills to reduce tension | Behavioural | Cognitive Behavioral Exposure Therapy |
| Cognitive RestructuringAlso: Cognitive Reframing, Positive self-talkLearning skills needed to cope better with distressing thoughts | Behavioural | Cognitive Behavioral Exposure Therapy |
| Behavioral ActivationAlso: Increasing physical activityLearning to initiate healthy activity | Behavioural | Cognitive Behavioral Exposure Therapy |
| ExposureAlso: Imaginal exposure, In vivo exposureCoaching in how to confront avoided thoughts, situations, and people) | Behavioural | Cognitive Behavioral Exposure Therapy |
Primary outcome
The Clinician Administered PTSD Scale (CAPS) and Survey of Activities and Fear of Falling in the Elderly (SAFE) will be primary outcomes.
Time frame: At initial assessment, following completion of intervention, and 3 months after completion of intervention
1 secondary outcome
Beck Anxiety Inventory, Beck Depression Inventory, Reintegration to Normal Living, Health Related Quality of Life, and other measures will be included.
Time frame: At initial assessment, following completion of intervention, and 3 months after completion of intervention
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 16 Aug 2016.
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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.
Nimali Jayasinghe, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Education, Relaxation Training and Cognitive Restructuring in people with Posttraumatic Stress Disorder (PTSD) and Specific Phobia, run by Weill Medical College of Cornell University 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 8 inclusion and 15 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 16 Aug 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The Clinician Administered PTSD Scale (CAPS) and Survey of Activities and Fear of Falling in the Elderly (SAFE) will be primary outcomes. (time frame: At initial assessment, following completion of intervention, and 3 months after completion of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2016; AzTrials last refreshed its copy on 27 Oct 2026.