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OpenTrials
Completed

NCT Number: NCT01268657

Intervention for Anxiety After 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.

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Key information

Age range

65 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Weill Cornell Medical College

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Education

Behavioral

Learning about anxiety

Other names: Psychoeducation

Relaxation Training

Behavioral

Learning skills to reduce tension

Other names: Relaxation, Stress Reduction, Stress Reduction Training

cognitive restructuring

Behavioral

Learning skills needed to cope better with distressing thoughts

Other names: Cognitive Reframing, Positive self-talk

Behavioral Activation

Behavioral

Learning to initiate healthy activity

Other names: Increasing physical activity

Exposure

Behavioral

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

Other names: Imaginal exposure, In vivo exposure

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.

    Time frame: 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.

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

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

Intervention for Disabling Anxiety in Older Adults Injured by Falls

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Dec 31, 2010
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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