- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00872820
Examining Long-Term Effects and Neural Mediators of Behavioral Treatments for Social Anxiety Disorder
Neural Mediators of Behavior Therapy for Anxiety
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Social anxiety disorder (SAD) is characterized by intense and debilitating anxiety in common social situations. Cognitive behavioral therapy (CBT) is a talking treatment that aims to reduce immediate anxiety symptoms. However, some anxiety symptoms and comorbid disorders not directly addressed by CBT may only improve in the short term, while recurring in the long term. Behavioral therapy based on acceptance and mindfulness is thought to have longer lasting effects, because this approach emphasizes accepting anxiety instead of controlling anxiety. This study will compare standard CBT to acceptance and commitment therapy (ACT), which uses acceptance and mindfulness, to determine which is more effective on both a short- and long-term basis. Participants with SAD will undergo brain scans to determine how the two therapies affect brain functioning.
Participation in this study will last 12 months. Participants with SAD will be randomly assigned to receive CBT, ACT, or a waitlist condition. Both CBT and ACT treatments will include 12 weekly sessions that will deal with objects and situations that provoke anxiety. All sessions will be audio- and videotaped. The waitlist group will complete weekly self-monitoring forms to track anxiety and panic and will receive a phone call from a research coordinator every 2 weeks to make sure symptoms have not worsened. After 12 weeks, participants on the waitlist will be offered treatment.
All participants will attend study visits to undergo brain scanning at baseline, after 3 months, and after 12 months. Each study visit will involve MRI scanning (to evaluate brain structure), functional MRI (fMRI) scanning (to evaluate brain function), questionnaires about a participant's experience in the scanner, and collection of saliva samples before, during, and after scanning. While undergoing the fMRI scan, participants will be asked to remain at rest for a certain period of time, and then to perform tasks that will engage certain parts of the brain. Assessments for all participants will occur at baseline and after 3, 6, and 12 months. These assessments will include diagnostic evaluations by a therapist, self-report questionnaires, ongoing self-monitoring, physiological measurements, cognitive assessments, and behavioral observation.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 90095
- UCLA Psychology Department - Franz Hall
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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:
- Meets diagnostic criteria for social anxiety disorder
- Right-handed
- If taking medications, stabilized on current dose for 3 months
- If undergoing psychotherapy, stabilized for 6 months
- Speaks English
Exclusion Criteria:
- Currently undergoing cognitive behavioral therapy
- History of psychiatric hospitalization in the last 5 years
- Presence of serious medical condition, such as respiratory, cardiovascular, pulmonary, neurological, or muscular-skeletal disease or pregnancy
- Active suicidal ideation
- Current severe depression
- History of bipolar disorder, psychosis, mental retardation, or brain damage
- History of substance abuse or dependence in the last 6 months
- Presence of irremovable metal objects in the body that are not fMRI-safe
- Suffers from claustrophobia
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: 1
Participants will receive standard cognitive behavioral therapy.
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12 weekly treatment sessions conducted individually with a therapist; methods for dealing with anxiety will include cognitive and breathing strategies
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Expérimental: 2
Participants will receive acceptance- and commitment-based behavioral therapy.
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12 weekly treatment sessions conducted individually with a therapist; strategies for dealing with anxiety will include mindfulness and acceptance of negative feelings
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Aucune intervention: 3
Participants will be placed on a waitlist for 3 months before being offered treatment.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Brain activity, assessed using functional magnetic resonance imaging (fMRI)
Délai: Measured at baseline and after 3 and 12 months
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Measured at baseline and after 3 and 12 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Social anxiety symptoms
Délai: Measured at baseline and after 3, 6, and 12 months
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Measured at baseline and after 3, 6, and 12 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Michelle G. Craske, PhD, University of California, Los Angeles
Publications et liens utiles
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
- R21MH081299 (Subvention/contrat des NIH des États-Unis)
- DATR A3-NSS (Indiana University)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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