- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00951340
Desensitization and Cognitive Therapy in General Anxiety.
연구 개요
상태
정황
상세 설명
Generalized anxiety disorder (GAD) is characterized by chronic worry that interrupts normal functioning. Some research has shown cognitive behavioral therapy (CBT) as an effective treatment for GAD, but only half of people treated with CBT for GAD experience treatment benefits long-term. Standard CBT for GAD may lose effectiveness over time because it does not address interpersonal and emotional processing problems. This study will determine the safety and feasibility of training therapists to deliver a version of CBT with additional therapeutic techniques for addressing interpersonal interactions and emotional processing.
Participation in this study will include 14 weekly, 2-hour, individual therapy sessions. During the first hour of each session, all participants will receive standard CBT for GAD. Participants will be randomly assigned to receive one of two therapies during the second hour: training in interpersonal and emotional processing techniques or listening therapy. Participants taking medications will be required to maintain a fixed dosage and keep a daily dairy of medication use, starting 2 weeks before study entry and lasting throughout treatment.
In-depth study assessments will take place at baseline and after completing the 15 weeks of therapy. Assessments will include clinical interviews, self-report questionnaires, and a physiological measurement session. Questions will pertain to anxiety symptoms, self-perceptions, emotional experience, and perceptions of the world. The physiological measurement session will involve recording bodily reactions, including brain waves, heart rate, eye movement, and breathing, while performing simple perceptual tasks. Brief psychological assessments will also follow each hour-long portion of each therapy session. Follow-up assessments conducted 6, 12, and 24 months after completing treatment will involve interviews and questionnaires as well as recording a week's worth of medication diaries.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Pennsylvania
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University Park, Pennsylvania, 미국, 16802-3103
- The Pennsylvania State University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Principal diagnosis of generalized anxiety disorder (GAD), as defined by the DSM-IV and agreed on by two diagnostic interviewers
Exclusion Criteria:
- Concurrent psychosocial therapy or past adequate dosage of CBT
- Medical contributions to anxiety
- Current substance abuse, psychosis, or organic brain syndrome
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: CBT with listening therapy
Participants will receive CBT with listening therapy.
|
15 weekly therapy sessions, the first hour of which will be devoted to standard CBT techniques
다른 이름들:
15 weekly therapy sessions, the second hour of which will be directed by the participant's questions and discussion
|
|
실험적: CBT with emotional processing and interpersonal therapy
Participants will receive CBT with emotional processing and interpersonal therapy.
|
15 weekly therapy sessions, the first hour of which will be devoted to standard CBT techniques
다른 이름들:
15 weekly therapy sessions, the second hour of which will be devoted to interpersonal and emotional processing therapy techniques
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Feasibility of delivering emotional processing and interpersonal therapeutic techniques
기간: Measured at baseline, post-treatment, and after 6, 12, and 24 months
|
Measured at baseline, post-treatment, and after 6, 12, and 24 months
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- R01MH039172-02 (미국 NIH 보조금/계약)
- 2R01MH039172-12 (미국 NIH 보조금/계약)
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. .