Combined Treatment for Generalized Anxiety Disorder (GAD)
23 de dezembro de 2016 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
69
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania, 3535 Market Street, Suite 650
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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).
Outros nomes:
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Comparador Ativo: 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).
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Hamilton Anxiety Rating Scale (HAM-A)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Hospital Anxiety Depression Scale (HAD)-Anxiety Score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Paul Crits-Christoph, PhD, University of Pennsylvania
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de outubro de 2006
Conclusão Primária (Real)
1 de março de 2008
Conclusão do estudo (Real)
1 de março de 2008
Datas de inscrição no estudo
Enviado pela primeira vez
7 de fevereiro de 2008
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de fevereiro de 2008
Primeira postagem (Estimativa)
21 de fevereiro de 2008
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de fevereiro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de dezembro de 2016
Última verificação
1 de dezembro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Transtornos Mentais, Desordem Mental
- Processos Patológicos
- Doença
- Transtornos de ansiedade
- Efeitos Fisiológicos das Drogas
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Drogas Psicotrópicas
- Inibidores de Captação de Neurotransmissores
- Moduladores de transporte de membrana
- Antidepressivos
- Agentes antidepressivos de segunda geração
- Inibidores da Recaptação de Serotonina e Noradrenalina
- Cloridrato de Venlafaxina
Outros números de identificação do estudo
- 802307
- 5R34MH072678-02 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .