Back on My Feet: Emotional Recovery From Fall Injury
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Lieux d'étude
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New York
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New York, New York, États-Unis, 10065
- Weill Cornell Medical College
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Exposure-based Cognitive Behavioral Therapy (ET)
Participants will receive exposure-based cognitive behavioral therapy
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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.
|
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Comparateur actif: Relaxation Training (RT)
Participants will receive relaxation training
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Change from baseline clinician-rated PTSD at 6 weeks
Délai: Baseline, Week 6
|
Baseline, Week 6
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Change from baseline fear of falling at 6 weeks
Délai: Baseline, Week 6
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Baseline, Week 6
|
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Change from baseline depression at 6 weeks
Délai: Baseline, Week 6
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Baseline, Week 6
|
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Change from baseline anxiety at 6 weeks
Délai: Baseline, Week 6
|
Baseline, Week 6
|
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Change from baseline self-reported PTSD at 6 weeks
Délai: Baseline, Week 6
|
Baseline, Week 6
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Nimali Jayasinghe, PhD, Weill Medical College of Cornell University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1306014003
- K23MH090244 (Subvention/contrat des NIH des États-Unis)
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