- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02953444
The Feasibility and Efficacy of an Extremely Brief Mindfulness Practice
연구 개요
상태
상세 설명
Mindfulness meditation and mindfulness-based therapies have been shown to improve many aspects of psychological functioning in individuals with mental health problems.
The purpose of this study is to assess the feasibility, acceptability, and efficacy in improving mental health of brief mindfulness practices in adults currently in treatment for mental health concerns. The entire study will be administered online. From online instructional videos, each participant will learn a thirty-second or three-minute mindfulness practice that is to be performed at least three times daily over two weeks. A delayed-treatment control group will begin the intervention after a two-week waiting period.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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North Carolina
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Durham, North Carolina, 미국
- Duke Office of Clinical Research REDCap Online Data Collection Software
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Regular internet access
- Able to listen to audio files
- Currently receiving outpatient care
- No change in type of psychotherapy during the past month
- If taking medications, a stable, unchanging prescription for the previous month
- Willingness to sign release of mental health care information
- Capacity to provide informed consent
Exclusion Criteria:
- Does not speak and read English
공부 계획
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 |
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간섭 없음: Wait List Control
Participants receive daily email surveys for two weeks before being given access to the brief-mindfulness-practice training materials.
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실험적: Thirty-Second Mindfulness Practice
Participants watch a ten minute mindfulness training video then are given electronic access to an audio recording of guidance for a thirty-second mindfulness meditation practice.
Participants are asked to complete this practice using the audio-recorded guidance at least three times a day for two weeks.
Participants are sent daily emails that include reminders to complete the practice and a link to a brief online survey.
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활성 비교기: Three-Minute Mindfulness Practice
Participants watch a ten minute mindfulness training video then are given electronic access to an audio recording of guidance for a three minute mindfulness meditation practice.
Participants are asked to complete this practice using the audio-recorded guidance at least three times a day for two weeks.
Participants are sent daily emails that include reminders to complete the practice and a link to a brief online survey.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Change in trait mindfulness as measured by the Five Facet Mindfulness Questionnaire (Baer et al. 2006)
기간: Baseline, 2 weeks and 4 weeks
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Baseline, 2 weeks and 4 weeks
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Change in perceived stress as measured by the Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983)
기간: Baseline, 2 weeks and 4 weeks
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Baseline, 2 weeks and 4 weeks
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Change in anxiety symptoms as measured by the GAD-7, Generalized Anxiety Disorder Scale (Spitzer, Kroenke, Williams, & Löwe, 2006)
기간: Baseline, 2 weeks and 4 weeks
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Baseline, 2 weeks and 4 weeks
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Change in mood as measured by the Positive and Negative Affect Schedule (Watson, Clark, & Tellegen, 1988)
기간: Baseline, 2 weeks and 4 weeks
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Baseline, 2 weeks and 4 weeks
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Change in quality of life as measured by the Medical Outcomes Study 36-Item Short-Form Health Survey (Ware & Sherbourne, 1992)
기간: Baseline, 2 weeks and 4 weeks
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Baseline, 2 weeks and 4 weeks
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Change in depression symptoms as measured by the PHQ-8, Patient Health Questionnaire - depression module (Spitzer, Kroenke, & Williams, 1999)
기간: Baseline, 2 weeks and 4 weeks
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Baseline, 2 weeks and 4 weeks
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2차 결과 측정
결과 측정 |
기간 |
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Group difference in intervention's acceptability as measured by qualitative questions
기간: 1 week into intervention
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1 week into intervention
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Group difference in adherence as measured by frequency of daily brief mindfulness practice use
기간: Daily for two weeks of intervention
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Daily for two weeks of intervention
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Group difference in continued brief mindfulness practice use as measured by follow-up question
기간: Follow up (two weeks after intervention)
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Follow up (two weeks after intervention)
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Change in daily mood measured on a visual analogue scale
기간: Daily for two weeks of intervention
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Daily for two weeks of intervention
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Change in daily stress level measured on a visual analogue scale
기간: Daily for two weeks of intervention
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Daily for two weeks of intervention
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Change in empathy as measured by the Interpersonal Reactivity Index (Davis, 1980) and four questions adapted from Hawk, Fischer and Van Kleef, (2011)
기간: Baseline, 2 weeks and 4 weeks
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Baseline, 2 weeks and 4 weeks
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Change in perspective taking as measured by questions adapted from Hawk, Fischer and Van Kleef, (2011)
기간: Baseline, 2 weeks and 4 weeks
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Baseline, 2 weeks and 4 weeks
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Moria Smoski, Ph.D, Duke University
간행물 및 유용한 링크
일반 간행물
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.
- Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
- Khoury B, Lecomte T, Fortin G, Masse M, Therien P, Bouchard V, Chapleau MA, Paquin K, Hofmann SG. Mindfulness-based therapy: a comprehensive meta-analysis. Clin Psychol Rev. 2013 Aug;33(6):763-71. doi: 10.1016/j.cpr.2013.05.005. Epub 2013 Jun 7.
- Davis, M.H. (1980). A multidimensional approach to individual differences in empathy. Catalogue of Selected Documents in Psychology, 10, MS. 2124, p. 85.
- Hawk ST, Fischer AH, Van Kleef GA. Taking your place or matching your face: two paths to empathic embarrassment. Emotion. 2011 Jun;11(3):502-13. doi: 10.1037/a0022762.
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- Pro00072981
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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