- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01268657
Intervention for Anxiety After Falls
Intervention for Disabling Anxiety in Older Adults Injured by Falls
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
-
-
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 > 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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Cognitive Behavioral Exposure Therapy
|
Learning about anxiety
Autres noms:
Learning skills to reduce tension
Autres noms:
Learning skills needed to cope better with distressing thoughts
Autres noms:
Learning to initiate healthy activity
Autres noms:
Coaching in how to confront avoided thoughts, situations, and people)
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
The Clinician Administered PTSD Scale (CAPS) and Survey of Activities and Fear of Falling in the Elderly (SAFE) will be primary outcomes.
Délai: At initial assessment, following completion of intervention, and 3 months after completion of intervention
|
At initial assessment, following completion of intervention, and 3 months after completion of intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Beck Anxiety Inventory, Beck Depression Inventory, Reintegration to Normal Living, Health Related Quality of Life, and other measures will be included.
Délai: At initial assessment, following completion of intervention, and 3 months after completion of intervention
|
At initial assessment, following completion of intervention, and 3 months after completion of intervention
|
Collaborateurs et enquêteurs
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- K23 MH 09244
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