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Combined Treatment for Generalized Anxiety Disorder (GAD)

2016년 12월 23일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

The specific aims of this study are to collect preliminary data relevant to the following hypotheses:

  1. Primary Hypothesis: Acute phase improvement for combined cognitive behavioral therapy (CBT) plus medication will be superior to medication alone.
  2. 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.
  3. 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.

연구 유형

중재적

등록 (실제)

69

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
        • University of Pennsylvania, 3535 Market Street, Suite 650

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
행동: Cognitive Behavioral Therapy
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.
의약품: Venlafaxine XR
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).
다른 이름들:
  • Effexor extended release
활성 비교기: 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.
의약품: Venlafaxine XR
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).
다른 이름들:
  • Effexor extended release

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Hamilton Anxiety Rating Scale (HAM-A)
기간: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
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.
Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24

2차 결과 측정

결과 측정
측정값 설명
기간
Hospital Anxiety Depression Scale (HAD)-Anxiety Score
기간: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
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.
Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
Hospital Anxiety Depression Scale (HAD)-Depression Score
기간: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
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.
Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
Hamilton Rating Scale for Depression (HAM-D)-17-item Score
기간: Data collected as part of protocol 709012 at baseline, week 12, and week 24
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.
Data collected as part of protocol 709012 at baseline, week 12, and week 24
Clinical Global Impression (CGI)-Severity Score
기간: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
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.
Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
Clinical Global Impression (CGI)-Improvement Score
기간: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
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.
Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
Quality of Life Subscale of the General Health Questionnaire (GHQ)
기간: Data collected as part of protocol 709012 at baseline, week 12, and week 24
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.
Data collected as part of protocol 709012 at baseline, week 12, and week 24
Penn State Worry Questionnaire (PSWQ)
기간: Data collected as part of protocol 709012 at baseline, week 12, and week 24
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.
Data collected as part of protocol 709012 at baseline, week 12, and week 24
Physical Component Score of the 12-Item Short Form Survey (SF-12)
기간: Data collected as part of protocol 709012 at baseline, week 12, and week 24
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.
Data collected as part of protocol 709012 at baseline, week 12, and week 24
Mental Component Score of the 12-item Short Form Survey (SF-12)
기간: Data collected as part of protocol 709012 at baseline, week 12, and week 24
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.
Data collected as part of protocol 709012 at baseline, week 12, and week 24
Clinical Response Rate
기간: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
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.
Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
50 Percent or Greater Reduction in PSWQ Score
기간: Data collected as part of protocol 709012 at baseline, week 12, and week 24
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.
Data collected as part of protocol 709012 at baseline, week 12, and week 24

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Pennsylvania

협력자

National Institute of Mental Health (NIMH)

수사관

  • 수석 연구원: Paul Crits-Christoph, PhD, University of Pennsylvania

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2006년 10월 1일

기본 완료 (실제)

2008년 3월 1일

연구 완료 (실제)

2008년 3월 1일

연구 등록 날짜

최초 제출

2008년 2월 7일

QC 기준을 충족하는 최초 제출

2008년 2월 7일

처음 게시됨 (추정)

2008년 2월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 2월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 12월 23일

마지막으로 확인됨

2016년 12월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 802307
  • 5R34MH072678-02 (미국 NIH 보조금/계약)

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아니요

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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