Psychotherapy and Cardiovascular Risk Factors in Depression
The Impact of Psychotherapy on Hemodynamic and Inflammatory Risk Factors for Cardiovascular Disease in Major Depression
Prospective studies indicate that patients with depression are at increased risk for cardiovascular disease. Depression is also associated with a number of hemodynamic features, which are known risk factors for cardiovascular morbidity such as increased heart rate, reduced heart rate variability and blood pressure alterations. These hemodynamic alterations may explain in part the increased cardiovascular risk associated with depression.
The purpose of this study is to determine whether treatment for depression with cognitive behavior therapy (CBT) is effective in reducing hemodynamic cardiovascular risk factors. Hemodynamic assessments including heart rate, heart rate variability, continues blood pressure, blood pressure variability, baroreceptor sensitivity and peripheral vascular resistance will be conducted at baseline, after treatment and 2-month follow up. In addition, circadian hemodynamic variations such as 24-hour heart rate variability, nocturnal blood pressure dipping and immunological biomarkers will be assessed. Eighty patients with Major Depression will be randomly assigned to either a CBT treatment condition (14 hour-long, weekly sessions) or a waitlist condition, to control for potential changes in hemodynamic parameters without any intervention and the impact of repeated-measurement.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Marburg, 독일, 35032
- Department of Clinical Psychology and Psychotherapy, Philipps University Marburg
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- patients with Major Depression (DSM IV), BDI >=14
- age:18-65 years
- patients without antidepressive medication (stable for at least 2 weeks)
- comorbidity with other psychiatric disorders is permitted, as far as depressive symptoms are dominating
Exclusion Criteria:
- current psychotherapy
- psychotic disorder
- serious drug-addiction
- drugs which seriously affect immune status (except contraceptives) or central
- nervous system functions (except antidepressants)
- infections during the last 2 weeks
- injuries during the last 2 weeks
- neurological disorders
- diseases which affect immune status or central nervous system functions (e.g. rheumatoid arthritis, CVD,etc.)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Cognitive behavioral therapy
Cognitive behavioral therapy for Major Depression
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간섭 없음: Waitlist group
Waitlist group to control for repeated physiological measures and fluctuations over time
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Change in depressive symptoms (BDI-II)
기간: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Change in heart rate variability
기간: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in blood pressure
기간: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in baroreceptor sensitivity (ms/mmHg)
기간: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in peripheral vascular resistance (dyne*s/cm5)
기간: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in C-reactive protein
기간: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in proinflammatory cytokines
기간: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in anti-inflammatory interleukin-10
기간: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change in Subjective social status (MacArthur scale)
기간: Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up
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공동 작업자 및 조사자
수사관
- 수석 연구원: Frank Euteneuer, PhD, Department of Clinical Psychology and Psychothearpy, Philipps University of Marburg
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 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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