Intervention for Anxiety After Falls

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nimali Jayasinghe, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01268657
First received: December 29, 2010
Last updated: October 7, 2014
Last verified: October 2014

December 29, 2010
October 7, 2014
January 2011
March 2015   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01268657 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Intervention for Anxiety After Falls
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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Posttraumatic Stress Disorder (PTSD)
  • Specific Phobia
  • Anxiety
  • Behavioral: Education
    Learning about anxiety
    Other Name: Psychoeducation
  • Behavioral: Relaxation Training
    Learning skills to reduce tension
    Other Names:
    • Relaxation
    • Stress Reduction
    • Stress Reduction Training
  • Behavioral: Cognitive Restructuring
    Learning skills needed to cope better with distressing thoughts
    Other Names:
    • Cognitive Reframing
    • Positive self-talk
  • Behavioral: Behavioral Activation
    Learning to initiate healthy activity
    Other Name: Increasing physical activity
  • Behavioral: Exposure
    Coaching in how to confront avoided thoughts, situations, and people)
    Other Names:
    • Imaginal exposure
    • In vivo exposure
Experimental: Cognitive Behavioral Exposure Therapy
Interventions:
  • Behavioral: Education
  • Behavioral: Relaxation Training
  • Behavioral: Cognitive Restructuring
  • Behavioral: Behavioral Activation
  • Behavioral: Exposure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
32
August 2015
March 2015   (final data collection date for primary outcome measure)

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)
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01268657
K23 MH 09244
Yes
Nimali Jayasinghe, Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Nimali Jayasinghe, PhD Weill Medical College of Cornell University
Weill Medical College of Cornell University
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP