Comparison of the Efficacy of an Integrative-kinesiological to a Cognitive-behavioural Intervention (IKSIT)
Psychoneuroendocrinological Efficacy Study of an Integrative-kinesiological to a Cognitive-behavioural Intervention With Healthy Individuals
Stress is a common problem with significant consequences for health. It can be a trigger for somatic diseases as well as psychological disorders and leads through missed working days and healthcare cost to a high economic loss. It is for health and economic reasons essential to develop and evaluate effective interventions that can inoculate against stress and build inner strength.
A cognitive-behavioural training for groups that is well evaluated and has shown to be effective is the Stress-Inoculation-Training by Meichenbaum. As the public utilization of methods of the complementary and alternative medicine is increasing a rigorous evaluation is needed. Integrative Kinesiology is a popular method that has been said to be effective against stress and its symptoms.
The investigators propose a randomized controlled evaluation and comparison of the interventions to each other and to a waiting-list control group. Hypothesis: Healthy volunteers attending a two dayseminar will show significantly reduced psychobiological reactivity, decreased stress perception and less anxiety to a standardized psychosocial stress test compared to the waiting list group. A total of 64 healthy volunteers will be randomly assigned to one of the three groups. The efficacy of the interventions will be measured through the Trier Social Stress Test (TSST) to measure the psychobiological stress reactivity.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 3단계
연락처 및 위치
연구 장소
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Zurich, 스위스, 8032
- University of Zurich
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Ready to participate in randomly one of the three groups
- mentally and physically healthy
- Sufficient German-speaking abilities to participate in the training
Exclusion Criteria:
- previous experience with Integrative Kinesiology or cognitive-behavioural therapy
- previous experience with the Trier Social Stress Test
- daily alcohol consumption: > two alcoholic drinks
- daily tobacco consumption: > 5 cigarettes per day
- any kind of drug abuse
- pregnancy, after the second trimenon
- intake ofe hormonal compounds (birth control pill and hormon replacement therapy)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: Cognitive behavioural Intervention
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Two day seminar
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실험적: Integrative Kinesiology Intervention
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Two day seminar
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간섭 없음: Waiting-List control group
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Area under curve with respect to increase of salivary cortisol titer
기간: 8x during TSST
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TSST evaluation day will take place between 2 weeks and one month on average after the treatments are finished. Trier Social Stress Tests procedure will last close to two hours. Samples are collected at: T + 02; +25; +38; +48; +58; + 1:08; +1:23; + 1.38 |
8x during TSST
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Salivary alpha amylase reactivity to the TSST
기간: 8x during TSST
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TSST evaluation day will take place between 2 weeks and one month on average after the treatments are finished. Trier Social Stress Tests procedure will last close to two hours. Samples are collected at: T + 02; +25; +38; +48; +58; + 1:08; +1:23; + 1.38 |
8x during TSST
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Sense of Coherence
기간: Baseline, post intervention and follow up
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Baseline: After recruitment and acceptance to the study Post: One week after the training is fulfilled Follow-up: One week after the TSST Measured by: Sense of Coherence questionnaire (SOC-L9) |
Baseline, post intervention and follow up
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Perceived Stress
기간: Baseline, post intervention and follow up
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Baseline: After recruitment and acceptance to the study Post: One week after the training is fulfilled Follow-up: One week after the TSST Measured by: Perceived Stress Scale (PSS) |
Baseline, post intervention and follow up
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self efficacy expectancy
기간: Baseline, post intervention and follow up
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Baseline: After recruitment and acceptance to the study Post: One week after the training is fulfilled Follow-up: One week after the TSST Measured by: Self-efficacy-expectancy questionnaire (SWE) |
Baseline, post intervention and follow up
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Lars B. Sonderegger, University of Zurich
- 연구 의자: Reinhard Saller, Prof., University of Zurich
- 연구 의자: Ulrike Ehlert, Prof., University of Zurich
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .