- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01998945
Back on My Feet: Emotional Recovery From Fall Injury
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Fall accidents can be frightening experiences that cause life-changing injuries. Each year, millions of older Americans who fall may develop disabling anxiety and related distress, functional limitations, and poor health.
Our previous study adapted a well-researched anxiety treatment, Exposure-based Cognitive Behavioral Therapy (ET), for older adults diagnosed with full posttraumatic stress disorder (PTSD), subsyndromal PTSD, or fear of falling after fall injury. The approach was well-accepted by subjects and they reported both reductions in anxiety and having more fully returned to normal living immediately after the treatment and then three months later.
The purpose of this pilot study is to compare ET to another active treatment, Relaxation Training (RT). Both study treatments will consist of eight home-based sessions. ET consists of education about anxiety, relaxation training, managing distressing thoughts, healthy routine, and confronting avoided memories and situations. RT consists of techniques to ease bodily tension.
Twenty-four subjects will be randomly assigned to one of the two treatment groups. The study will compare how subjects in each group improve on outcomes such as diagnosis, anxiety severity, and quality of life over the course of treatment, and at three- and six-month follow-up.
The findings will provide the basis for larger future studies.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
- Fas 1
Kontakter och platser
Studieorter
-
-
New York
-
New York, New York, Förenta staterna, 10065
- Weill Cornell Medical College
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Age 60 years and older
- Fall accident requiring emergency room or inpatient hospital medical care with return home within past nine months
- Community dwelling
- Able to ambulate independently or with an assistive device
- English-speaking
- Diagnosis of PTSD, subsyndromal PTSD, or Fear of Falling (determined by interview)
Exclusion Criteria:
- Cognitive impairment
- Serious or terminal illness
- Aphasia
- Current substance abuse
- Lifetime history of psychotic disorder and/or bipolar disorder
- Active suicidal or homicidal ideation
- Prescription psychotropic medication begun < 6 weeks
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Exposure-based Cognitive Behavioral Therapy (ET)
Participants will receive exposure-based cognitive behavioral therapy
|
Eight 75-minute, in-home sessions delivered twice weekly for 4 weeks of exposure-based cognitive behavioral therapy, a time-limited treatment that focuses on confronting avoided memories and situations and identifying and managing distressing thoughts.
|
Aktiv komparator: Relaxation Training (RT)
Participants will receive relaxation training
|
Eight 75-minute, in-home sessions delivered twice weekly for 4 weeks of Relaxation Training, that focus on muscle relaxation and diaphragmatic breathing to address the physical symptoms of anxiety.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Change from baseline clinician-rated PTSD at 6 weeks
Tidsram: Baseline, Week 6
|
Baseline, Week 6
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Change from baseline fear of falling at 6 weeks
Tidsram: Baseline, Week 6
|
Baseline, Week 6
|
Change from baseline depression at 6 weeks
Tidsram: Baseline, Week 6
|
Baseline, Week 6
|
Change from baseline anxiety at 6 weeks
Tidsram: Baseline, Week 6
|
Baseline, Week 6
|
Change from baseline self-reported PTSD at 6 weeks
Tidsram: Baseline, Week 6
|
Baseline, Week 6
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Nimali Jayasinghe, PhD, Weill Medical College of Cornell University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1306014003
- K23MH090244 (U.S.S. NIH-anslag/kontrakt)
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