NCT01268657

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2010

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

2.8 years

First QC Date

December 29, 2010

Last Update Submit

August 13, 2016

Conditions

Keywords

PTSDFear of FallingOlder AdultsInjurious FallsExposure Therapy

Outcome Measures

Primary Outcomes (1)

  • The Clinician Administered PTSD Scale (CAPS) and Survey of Activities and Fear of Falling in the Elderly (SAFE) will be primary outcomes.

    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.

    At initial assessment, following completion of intervention, and 3 months after completion of intervention

Study Arms (1)

Cognitive Behavioral Exposure Therapy

EXPERIMENTAL
Behavioral: EducationBehavioral: Relaxation TrainingBehavioral: Cognitive RestructuringBehavioral: Behavioral ActivationBehavioral: Exposure

Interventions

EducationBEHAVIORAL

Learning about anxiety

Also known as: Psychoeducation
Cognitive Behavioral Exposure Therapy

Learning skills to reduce tension

Also known as: Relaxation, Stress Reduction, Stress Reduction Training
Cognitive Behavioral Exposure Therapy

Learning skills needed to cope better with distressing thoughts

Also known as: Cognitive Reframing, Positive self-talk
Cognitive Behavioral Exposure Therapy

Learning to initiate healthy activity

Also known as: Increasing physical activity
Cognitive Behavioral Exposure Therapy
ExposureBEHAVIORAL

Coaching in how to confront avoided thoughts, situations, and people)

Also known as: Imaginal exposure, In vivo exposure
Cognitive Behavioral Exposure Therapy

Eligibility Criteria

Age65 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to understand assessment questions
  • Marked cognitive impairment
  • Dementia
  • Schizophrenia
  • Bipolar Disorder
  • Depression with psychotic features
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticPhobia, SpecificAnxiety Disorders

Interventions

Educational StatusRelaxation TherapyMindfulness-Based Stress ReductionCognitive RestructuringImplosive Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesMindfulnessCognitive Behavioral TherapyDesensitization, Psychologic

Study Officials

  • Nimali Jayasinghe, PhD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychology in Clinical Psychiatry

Study Record Dates

First Submitted

December 29, 2010

First Posted

December 31, 2010

Study Start

January 1, 2011

Primary Completion

November 1, 2013

Study Completion

February 1, 2014

Last Updated

August 16, 2016

Record last verified: 2016-08

Locations