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Mechanisms of Mindfulness Training and Stress Reduction

2017년 1월 30일 업데이트: Carnegie Mellon University
This study is a three-arm randomized controlled trial of a mindfulness stress reduction intervention, with the aim of dismantling the experience-monitoring and nonjudgmental-acceptance elements of mindfulness programs to determine the active treatment component. In addition to enhancing understanding of mechanisms underlying the effects of mindfulness interventions, identifying the therapeutic constituent(s) could inform development of targeted interventions as well as provide strategies to optimize adherence.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

There is a growing body of randomized controlled trial (RCT) evidence indicating that mindfulness training interventions may reduce stress and improve stress-related disease outcomes. Yet little is known about the underlying active training mechanisms of mindfulness training. Although it is generally believed that mindfulness training interventions foster a capacity to monitor and accept present moment experience, debate currently focuses on whether it is the capacity to both monitor and non-judgmentally accept experience that drives the salutary effects observed in mindfulness training interventions. This project will test these putative active mechanisms by comparing two different types of mindfulness meditation training programs. N=135 stressed community adults will be recruited and randomized to either two different types of 8-week Mindfulness-Based Stress Reduction (MBSR) programs or a No Treatment Control (assessment only) comparison condition. Participants will complete 3 days of daily experience sampling (Ecological Momentary Assessment) immediately before and after the 8-week intervention period to measure attentional control and stress perceptions in daily life. In order to measure psychological and HPA-axis stress reactivity to a controlled stressor, participants will also complete a standardized acute stress challenge task (the Trier Social Stress Test, TSST) immediately following the 3-day post-intervention assessment period. This project provides the first dismantling study of mindfulness meditation training, it utilizes cutting-edge daily experience sampling of real life stress (using EMA) and stress biomarkers (salivary cortisol), and will provide important initial information for designing more effective (and efficient) mindfulness training interventions in at-risk stressed patient populations.

연구 유형

중재적

등록 (실제)

137

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

  • 미국
    • Pennsylvania
      • Pittsburgh, Pennsylvania, 미국, 15213
        • Carnegie Mellon University
      • Pittsburgh, Pennsylvania, 미국, 15232
        • University of Pittsburgh Medical Center- Center for Integrative Medicine
      • University Park, Pennsylvania, 미국, 16802
        • Pennsylvania State University

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 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • English speaking
  • Moderate- to high-stress
  • Owns an internet-enabled smart phone

Exclusion Criteria:

  • Diagnosis of chronic mental (e.g. recurrent depression, schizophrenia, personality disorder) or physical disease (e.g. cancer, HIV, diabetes)
  • Hospitalization in past 3 months
  • Medication use that interferes with cortisol activity (e.g. corticosteroids)
  • Current oral contraceptive use
  • Pregnancy
  • Current antibiotic, antiviral, or antimicrobial treatment
  • Travel outside the country within the past 6 months to any country on the Center for Disease Control travel alert list
  • Recreational drug use, excessive alcohol or tobacco use
  • Significant experience with or daily practice of mindfulness meditation or related mind-body practice

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Mindfulness Training
Mindfulness training intervention consisting of eight weekly 2.5 hour group sessions, a day-long retreat in the sixth week, and daily home mindfulness meditation
행동: Mindfulness
Mindfulness training practices aim to foster attention and acceptance toward one's present moment experience. Mindfulness consists of two components-- (1) deploying attention to monitor one's moment-to-moment experience, and (2) fostering an attitude of acceptance toward one's moment-to-moment experience
활성 비교기: Mindful Attention Only Training
Mindful attention only training intervention consisting of eight weekly 2.5 hour group sessions, a day-long retreat in the sixth week, and daily home mindfulness meditation
행동: Mindfulness
Mindfulness training practices aim to foster attention and acceptance toward one's present moment experience. Mindfulness consists of two components-- (1) deploying attention to monitor one's moment-to-moment experience, and (2) fostering an attitude of acceptance toward one's moment-to-moment experience
간섭 없음: No Treatment Control Condition
No treatment participants will be informed that their participation is important and that they are requested to not seek out similar treatments during this waiting period.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Daily life stress assessed via Ecological Momentary Assessment
기간: change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks

2차 결과 측정

결과 측정
기간
Daily life state attention and acceptance assessed via Ecological Momentary Assessment
기간: change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
Subjective stress in response to social evaluative threat
기간: assessed at post-intervention, which is an average of 14 weeks
assessed at post-intervention, which is an average of 14 weeks
Salivary Cortisol in response to social evaluative threat
기간: assessed at post-intervention, which is an average of 14, at time 0, and 25, 35, and 60 minutes post-stress challenge
assessed at post-intervention, which is an average of 14, at time 0, and 25, 35, and 60 minutes post-stress challenge
Blood Pressure reactivity to social evaluative threat (systolic and diastolic blood pressure)
기간: assessed at post-intervention, which is an average of 14 weeks, at 2-minute intervals during session
assessed at post-intervention, which is an average of 14 weeks, at 2-minute intervals during session
Sustained attention measured by the Dichotic Listening Task
기간: change from baseline to post-intervention, which is an average of 14 weeks
change from baseline to post-intervention, which is an average of 14 weeks
Sustained inattentional blindness measured by the Inattentional Blindness Task
기간: post-intervention only
post-intervention only

기타 결과 측정

결과 측정
기간
Daily life affect assessed via Ecological Momentary Assessment
기간: change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
Daily life social interactions assessed via Ecological Momentary Assessment
기간: change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
Perceived stress using the Perceived Stress Scale
기간: change from baseline to post-intervention, which is an average of 14 weeks
change from baseline to post-intervention, which is an average of 14 weeks
Attentional control using the Attentional Control Scale
기간: change from baseline to post-intervention, which is an average of 14 weeks
change from baseline to post-intervention, which is an average of 14 weeks
Treatment expectancies
기간: post-intervention an average of 14 weeks after the baseline
post-intervention an average of 14 weeks after the baseline
Subjective responses to the training program intervention
기간: composite of ratings made after each intervention lesson, an average of 10 weeks following baseline
composite of ratings made after each intervention lesson, an average of 10 weeks following baseline
Mindfulness using the Mindful Attention Awareness Scale
기간: change from baseline to post-intervention, which is an average of 14 weeks
change from baseline to post-intervention, which is an average of 14 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Carnegie Mellon University

협력자

University of Pittsburgh
Penn State University

수사관

  • 연구 의자: Wendy Weber, Ph.D., National Center for Complementary and Integrative Health, National Institutes of Health

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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

2015년 7월 1일

기본 완료 (실제)

2017년 1월 1일

연구 완료 (실제)

2017년 1월 1일

연구 등록 날짜

최초 제출

2015년 7월 7일

QC 기준을 충족하는 최초 제출

2015년 7월 16일

처음 게시됨 (추정)

2015년 7월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2017년 2월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 1월 30일

마지막으로 확인됨

2017년 1월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 1R21AT008493-01A1 (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. .

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