Combined Treatment for Generalized Anxiety Disorder (GAD)
23 décembre 2016 mis à jour par: Paul Crits-Christoph, University of Pennsylvania
The purpose of this study is to conduct a preliminary evaluation of the efficacy of combined medication and psychotherapy for generalized anxiety disorder (GAD).
The general goals of the current study are to conduct a late stage treatment development study.
The goal of this stage of research is to provide a preliminary answer to the question and to gather data to estimate intervention parameters (e.g., effect size, attrition rates, response rates) that would assist in planning further research.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
The specific aims of this study are to collect preliminary data relevant to the following hypotheses:
- Primary Hypothesis: Acute phase improvement for combined cognitive behavioral therapy (CBT) plus medication will be superior to medication alone.
- Secondary Hypotheses: Combined CBT plus medication will be superior to medication alone on a number of secondary outcome measures, including the core feature of GAD (worry), depressive symptoms, functional impairment, and quality of life.
- Additional Exploratory Aim: We will explore the comparative relapse rates for the combined CBT plus medication treatment and the medication alone treatment condition at 6-month follow-up.
Type d'étude
Interventionnel
Inscription (Réel)
69
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- University of Pennsylvania, 3535 Market Street, Suite 650
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- GAD diagnosis by structured interview
- Hamilton Anxiety Scale score of 18 or less
- Clinical Global Impressions Scale score of at least 4
- Hamilton Depression Scale score of 18 or less
- Hamilton Depression Scale suicide item score less than 2
- Use of an effective form of contraception throughout the s
Exclusion Criteria:
- Hypersensitivity to venlafaxine XR
- History of seizures
- Episode of major depressive disorder in the previous 6 months
- History of any psychotic illness, bipolar disorder, or dementia
- Substance abuse and dependence during the past 6 months
- Other anxiety disorders with the exception of social phobia as long as GAD is primary
- Regular use of anxiolytics or antidepressants within 7 days of study onset
- Use of fluoxetine or monoamine oxidase inhibitors within 28 days of study onset (low dose usage of benzodiazepines will not prevent participation)
- Use of other psychotic medication besides benzodiazepines
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
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 |
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Expérimental: Combined Treatment
Patients who receive combined cognitive behavioral therapy (CBT) plus medication (venlafaxine XR, flexibly dosed between 75-225 mg/day) treatment for GAD.
CBT was once/week sessions for 12 weeks.
Medication continued for the full 6 months.
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This cognitive behavioral therapy for GAD has a cognitive restructuring component and an applied relaxation component.
Patients will be educated about the nature of anxiety and be trained in the recognition and monitoring of situational, physiological, cognitive, and behavioral cues associated with anxious responding.
They will be guided through copings skill rehearsals in addition to imaginal and in vivo exposure to anxiety cues.
This cognitive behavioral treatment will consist of 1 to 1.5 hour sessions of psychotherapy, which will be held once weekly over a period of 12 weeks.
Venlafaxine XR, 75-225 mg/d, oral administration.
14 days at 75 mg/d, 150 mg/d for the remaining 6 months, 225 mg/3 for patients unimproved at week 6, tapered at 75 mg/week (this intervention is provided by protocol 709012).
Autres noms:
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Comparateur actif: Venlafaxine XR 75-225 mg alone
These patients receive only medication treatment for GAD.
Patients take venlafaxine (flexibly dosed from 75-225 mg/day) as part of NCT00183274 and are assessed over a 6 month period.
Medication continued for the full 6 months.
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Venlafaxine XR, 75-225 mg/d, oral administration.
14 days at 75 mg/d, 150 mg/d for the remaining 6 months, 225 mg/3 for patients unimproved at week 6, tapered at 75 mg/week (this intervention is provided by protocol 709012).
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Hamilton Anxiety Rating Scale (HAM-A)
Délai: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
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The HAM-A was used to measure the severity of anxiety symptoms.
The scale consists of 14 items; each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate and 25-30 moderate to severe anxiety.
This measure was conducted by research psychiatrists trained and highly experienced in the use of these scales.
The evaluators were blind to group assignment.
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Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Hospital Anxiety Depression Scale (HAD)-Anxiety Score
Délai: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
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The HAD was used to assess patients' report of anxiety and depressive symptoms.
Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
A higher score indicates greater anxiety.
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Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
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Hospital Anxiety Depression Scale (HAD)-Depression Score
Délai: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
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The HAD was used to assess patients' report of anxiety and depressive symptoms.
Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
A higher score indicates greater depression.
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Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
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Hamilton Rating Scale for Depression (HAM-D)-17-item Score
Délai: Data collected as part of protocol 709012 at baseline, week 12, and week 24
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The 17-item version of the HAM-D was used to assess severity of depressive symptoms.
Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe.
Nine are scored from 0-2.The total score is the sum of the 17 items, with a range from 0 to 50.
A higher scores indicates greater depression.
The ratings were conducted by research psychiatrists trained and highly experienced in the use of these scales.
The evaluators were blind to group assignment.
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Data collected as part of protocol 709012 at baseline, week 12, and week 24
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Clinical Global Impression (CGI)-Severity Score
Délai: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
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The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale (1=normal; 7 = extremely ill) that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
The ratings were conducted by research psychiatrists trained and highly experienced in the use of these scales.
Evaluators were blind to group assignment.
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Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
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Clinical Global Impression (CGI)-Improvement Score
Délai: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
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The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale (1= very much improved; 7 = very much worse) that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
The ratings were conducted by research psychiatrists trained and highly experienced in the use of these scales.
Evaluators were blind to group assignment.
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Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
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Quality of Life Subscale of the General Health Questionnaire (GHQ)
Délai: Data collected as part of protocol 709012 at baseline, week 12, and week 24
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The General Health Questionnaire (GHQ) is a psychometric screening tool to identify common psychiatric conditions.
Patients completed the 12 quality of life questions (each on a 0 to 3 scale) on this questionnaire.
Scores on the 12 items were added up to create summary score (range = 0 to 36).
Higher scores indicate worse health.
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Data collected as part of protocol 709012 at baseline, week 12, and week 24
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Penn State Worry Questionnaire (PSWQ)
Délai: Data collected as part of protocol 709012 at baseline, week 12, and week 24
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The Penn State Worry Questionaire is a 16-item inventory that aims to measure the trait of worry, using Likert rating from 1 (not at all typical of me) to 5 (very typical of me).
A total score is calculated (range = 16 to 80), with higher scores indicating greater worry.
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Data collected as part of protocol 709012 at baseline, week 12, and week 24
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Physical Component Score of the 12-Item Short Form Survey (SF-12)
Délai: Data collected as part of protocol 709012 at baseline, week 12, and week 24
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The Short Form (12) Health Survey is a 12-item, patient-reported survey of patient health.
Physical and Mental Health Component Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
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Data collected as part of protocol 709012 at baseline, week 12, and week 24
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Mental Component Score of the 12-item Short Form Survey (SF-12)
Délai: Data collected as part of protocol 709012 at baseline, week 12, and week 24
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The Short Form (12) Health Survey is a 12-item, patient-reported survey of patient health.
Physical and Mental Health Component Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
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Data collected as part of protocol 709012 at baseline, week 12, and week 24
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Clinical Response Rate
Délai: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
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Clinical response on the HAM-A was defined as a 50% or greater reduction from baseline to last value with the 24-week open label medication phase.
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Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
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50 Percent or Greater Reduction in PSWQ Score
Délai: Data collected as part of protocol 709012 at baseline, week 12, and week 24
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Clinically significant change was defined on the PSWQ as an estimated (based on linear mixed effects model) endpoint score of less than 50.9.
This score was calculated using the PSWQ normative data provided by Gillis, Haaga, and Ford (1995) and the baseline PSWQ mean and standard deviation (SD) from the current sample.
The PSWQ mean and SD from the normative and current GAD samples were entered into the Jacobson et al. (1984) formula "c" for clinically significant change.
This method provides a cutoff indicating whether or not the level of functioning by a patient is statistically more likely to be in the functional rather than the dysfunctional population.
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Data collected as part of protocol 709012 at baseline, week 12, and week 24
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Paul Crits-Christoph, PhD, University of Pennsylvania
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2006
Achèvement primaire (Réel)
1 mars 2008
Achèvement de l'étude (Réel)
1 mars 2008
Dates d'inscription aux études
Première soumission
7 février 2008
Première soumission répondant aux critères de contrôle qualité
7 février 2008
Première publication (Estimation)
21 février 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 février 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 décembre 2016
Dernière vérification
1 décembre 2016
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Processus pathologiques
- Maladie
- Troubles anxieux
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Médicaments psychotropes
- Inhibiteurs de l'absorption des neurotransmetteurs
- Modulateurs de transport membranaire
- Agents antidépresseurs
- Agents antidépresseurs, deuxième génération
- Inhibiteurs de la recapture de la sérotonine et de la noradrénaline
- Chlorhydrate de venlafaxine
Autres numéros d'identification d'étude
- 802307
- 5R34MH072678-02 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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NON
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