- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00947570
Neural Functioning Underlying Anxiety and Its Treatment (The INSULA Study)
Neural Substrates of Anticipation and Interoception in Anxiety Disorders
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Anxiety disorders are characterized by excessive and irrational fears of common situations that impair normal functioning. Neuroimaging allows researchers to examine brain functioning as people are presented with tasks that provoke or model anxiety. Neuroimaging research suggests that anxiety is moderated by a neural circuit involving three parts of the brain: the amygdala, the insula, and the prefrontal cortex (PFC). Increased activation of the amygdala and insula is associated with high anxiety, although activation of the PFC is thought to reduce anxiety. Cognitive behavioral therapy (CBT) is the only type of psychotherapy with strong evidence for effectively treating panic disorder (PD) and generalized anxiety disorder (GAD), but it only works about half the time. This study will use neuroimaging to examine when and how CBT affects brain functioning in people with PD and GAD. The long-term goals of the research are to develop neuroimaging as a diagnostic tool, to use neuroimaging to predict treatment response, and to understand which changes in brain functioning are related to successful treatment.
Participation in this study will last approximately 3 months. Four groups of participants will be recruited: healthy controls and people with PD, GAD, or social phobia (SP). All participants will undergo functional magnetic resonance imaging (fMRI) scanning-a measure of brain functioning-at the first visit. During the fMRI scan, participants will be asked to perform computerized tasks that involve responding to images. This will be the only visit that the healthy controls and people with SP complete; their inclusion in the study establishes a comparison point for the brain scans of the other participants. People with PD and GAD will then be asked to complete 10 sessions of CBT over a 10- to 14-week period. After 3 months, these participants will again undergo fMRI scanning. At 3 and 6 months after the completion of CBT, these participants will be asked to complete follow-up questionnaires about their anxiety.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- High school or higher education
- DSM-IV diagnosis of panic disorder (with ongoing symptoms), generalized anxiety disorder, or both
Exclusion Criteria:
- Lifetime diagnosis of psychotic disorder, organic mental disorder, or bipolar I disorder
- Substance dependence within the last 12 months or diagnosis of alcohol or substance abuse within the past month
- Use of psychotropic or anti-epileptic medications within the past 6 weeks
- Heavy caffeine use, defined as drinking more than 6 caffeinated beverages per day
- Current smoker
- Possibility of pregnancy
- History of claustrophobia or difficulty lying flat for long periods
- Ferrous metal in the body
Exclusion Criteria for Healthy Controls only:
- Lifetime diagnosis of major depressive disorder (MDD), bipolar I or II disorder, panic disorder (PD), agoraphobia without panic, generalized anxiety disorder (GAD), social phobia (SP), post-traumatic stress disorder (PTSD), obsessive-compulsive disorder (OCD), or an eating disorder
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- 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 therapy
Participants with panic disorder or generalized anxiety disorder (GAD) will receive a course of individual cognitive behavioral therapy targeted at their principal disorder.
|
10 sessions delivered over the course of 14 weeks and aimed at reducing pathological behaviors and patterns of thought
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Blood oxygen level dependent (BOLD) response in amygdala, insula, and medial prefrontal cortex, as measured with functional magnetic resonance imaging (fMRI)
Délai: Measured at baseline and after 10 to 14 weeks of treatment
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Measured at baseline and after 10 to 14 weeks of treatment
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Murray B. Stein, MD, MPH, University of California, San Diego
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
- R01MH065413 (Subvention/contrat des NIH des États-Unis)
- DATR A2-AIA
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 .
Essais cliniques sur Cognitive behavioral therapy for anxiety
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Boston Children's HospitalComplétéStress, Psychologique | Problème d'acculturationÉtats-Unis
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University of KonstanzWorld BankInconnueTrouble de stress post-traumatique | Agressivité appétitiveCongo
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Norwegian Center for Violence and Traumatic Stress...King's College London; University of Oslo; Ministry of Health and Care Services...RecrutementSSPT | Qualité de vie | Troubles du sommeil | Symptômes dépressifsNorvège
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University of KonstanzComplétéAgressivité appétitiveAllemagne
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VA Office of Research and DevelopmentComplétéTroubles de stress, post-traumatiqueÉtats-Unis
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University of WashingtonNational Institute on Drug Abuse (NIDA)ComplétéTroubles liés à l'utilisation de substances | Troubles de stress post-traumatique | Sexe à risqueÉtats-Unis