- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03563911
Brief Mindfulness and Nutrition-Based Interventions for Chronic Pain: Strategies to Ease Pain (STEP)
Brief Mindfulness-Based Intervention for Chronic Pain: A Pilot Randomized Clinical Trial
연구 개요
상태
상세 설명
Participants. To gather pilot data on the effects of BMBI, the investigators will aim to enroll up to 60 participants (up to 30 in each condition). Participants will be adults with chronic non-cancer pain (daily pain for at least 3 months).
Outcomes. Outcome measures were selected based on existing recommendations, including IMMPACT guidelines, for efficacy trials in chronic pain.
- Aim #1: Test the effects of BMBI, relative to control, on central pain processing using quantitative sensory testing. Quantitative sensory testing (cold pressor test and pressure algometer) will be used to characterize pain processing: pain threshold (i.e., when pain is first detected), pain tolerance (i.e., the duration of time that pain can be tolerated), and pain severity (i.e., intensity of pain). In the cold pressor test, a participant will be asked to place his or her hand in an ice bath until the pain is too great to remain in the water. Consistent with past research, a 15 liter refrigerated circulator (Polyscience MX15R-30-A11B) with water temperature set as low as 1°C will be used. In the pressure algometer test, the algometer will be used to apply pressure to the skin until the pain can no longer be tolerated. The investigators will utilize a device widely used in alogmeter pain research (Wagnder Force One Alogmeter FIPX).
- Aim #2: Test the immediate effects of BMBI, relative to control, on state self-report measures of pain, negative affect, and decentering. State self-report outcomes include: state decentering (7-item Decentering Subscale of the Toronto Mindfulness Scale), state pain intensity (1 item from the Brief Pain Inventory), state pain unpleasantness (1-item rated on 0-10 scale), state anxiety (1-item rated on 0-10 scale), state distress (1-item rated on 0-10 scale), state relaxation (1-item rated on 0-10 scale), and outcome expectancies (5-item Outcome Expectancies Questionnaire).
- Aim #3: Test longer-term effects of BMBI, relative to control, on trait self-report measures of pain, negative affect, trait mindfulness, and well-being. Trait self-report outcomes include: pain intensity and interference (9-item Brief Pain Inventory), anxiety and depression (14-item Hospital Anxiety and Depression Scale), trait mindfulness (15-item Mindful Attention Awareness Scale), psychological well-being (10-item Schwartz Outcome Scale), and home practice over the 4-week follow-up period (TLFB method).
Procedure. Participants will be recruited primarily via flyers and postings in newspapers and on the Internet. Prospective participants will be screened by phone (about 30 minutes). Provisionally eligible participants will be asked to attend a 1-hour appointment, which will begin with informed consent procedures (5-10 minutes) and a pre-intervention assessment (about 20 minutes; includes demographics questionnaire, self-report outcome measures, and quantitative sensory testing).
Eligible participants will be randomized to a condition, complete a 20-minute session of either BMBI or Control, and undergo a postintervention assessment (about 10 minutes; includes self-report outcome measures and quantitative sensory testing). Following the assessment, participants will be encouraged to practice the technique associated with their intervention (i.e., practicing mindfulness technique in BMBI, preparing healthy meals in Control) 20 minutes/day for 1 week at home and to track their practice and opioid use during the follow-up period; the follow-up assessments will be conducted over the phone by a research assistant and include the self-report outcome measures (no quantitative sensory testing). All study procedures are anticipated to last 2 hours and 30 minutes (30 minutes for screening, 1 hour for in-person appointment, and 30 minutes for each follow-up assessment).
Interventions: The BMBI is be based on a BMBI which demonstrated analgesic effects in a previous study. Relative to full-length interventions, the investigators will employ a brief intervention (i.e., one, 20-minute session) that could be delivered in routine clinical care, e.g., in primary care, and that could overcome cost and time/effort barriers associated with longer treatments. The 20-minute BMBI session will include education on the foundational concepts of mindfulness and its relevance to chronic pain (5 minutes) and a guided mindfulness practice involving focused attention on the breath and monitoring of thoughts, feelings, and body sensations (15 minutes). BMBI participants will be encouraged to practice the taught mindfulness technique at home at least 20 minutes/day for 1 week (a handout and link to an online guided mindfulness practice will be provided).
The Control intervention will involve nutrition education, adapted from an existing manual of cognitive-behavioral therapy for opioid-treated chronic pain. Control intervention protocol will match the BMBI in terms of time / structure to control for the non-specific, non-mindfulness effects of BMBI. The 20-minute Control session will include education on the relationship between diet and pain (10 minutes) and recommendations for a healthy diet (10 minutes). Control participants will be encouraged to prepare healthy meals at home at least 20 minutes/day for 1 week (a handout and link to online resources will be provided).
연구 유형
단계
- 해당 없음
연락처 및 위치
연구 장소
-
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Wisconsin
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Madison, Wisconsin, 미국, 53715
- University of Wisconsin
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- English-speaking
- ≥ 18 years old
- Chronic non-cancer pain (daily pain for at least 3 months)
- Average daily pain score ≥3 on a 0-10 numerical rating scale (question from the Brief Pain Inventory)
- Treatment with ≥30 mg/day of morphine-equivalent dose for ≥3 months
- Capable of giving informed consent
- Willing to complete all study activities
Exclusion Criteria:
- Cancer pain
- Current pregnancy
- Diagnosed with psychotic or bipolar (mania) disorders ("active" in the prior 12 months)
- Inability to safely or reliably participate in the study
- Regular mindfulness meditation practice
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 |
---|---|
실험적: Brief Mindfulness-Based Intervention
Those assigned to the Brief Mindfulness-Based Intervention (BMBI) Arm will receive BMBI.
|
The BMBI is be based on a BMBI which demonstrated analgesic effects in a previous study.
Relative to full-length interventions, we will employ a brief intervention; the 20-minute BMBI session will include education on the foundational concepts of mindfulness and its relevance to chronic pain (5 minutes) and a guided mindfulness practice involving focused attention on the breath and monitoring of thoughts, feelings, and body sensations (15 minutes).
BMBI participants will be encouraged to practice the taught mindfulness technique at home at least 20 minutes/day for 1 week (a handout and link to an online guided mindfulness practice will be provided).
|
활성 비교기: Control/Nutrition Education
Those assigned to the Control/Nutrition Education Arm will receive the nutrition education intervention.
|
The Control intervention will involve nutrition education, adapted from an existing manual of cognitive-behavioral therapy for opioid-treated chronic pain.
Control intervention protocol will match the BMBI in terms of time / structure to control for the non-specific, non-mindfulness effects of BMBI.
The 20-minute Control session will include education on the relationship between diet and pain (10 minutes) and recommendations for a healthy diet (10 minutes).
Control participants will be encouraged to prepare healthy meals at home at least 20 minutes/day for 1 week (a handout and link to online resources will be provided).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Cold pressor testing
기간: 1 hour
|
Cold pressor testing will be used to characterize pain processing (e.g., pain threshold, pain tolerance, pain severity).
In the cold pressor test, a participant is asked to place his or her hand and forearm in an ice bath until the pain is too great to remain in the water.
Consistent with past research, a 15 liter refrigerated circulator (Polyscience MX15R-30-A11B) with water temperature set as low as 1°C will be used in the present study.
|
1 hour
|
Pressure algometer testing
기간: 1 hour
|
Pressure algometer testing will be used to characterize pain processing (e.g., pain threshold, pain tolerance, pain severity).
In the pressure algometer test, the algometer is used to apply pressure to the skin until the pain can no longer be tolerated.
In the current study, we will utilize a device widely used in alogmeter pain research (Wagnder Force One Alogmeter FIPX).
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1 hour
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Brief Pain Inventory
기간: 4 weeks
|
Measures: 1) pain severity= mean of items 3-6 (ranges from 0-10 with higher scores indicating greater pain severity), and 2) pain interference= mean of items 9A-9G (ranges from 0-10 with higher scores indicating greater pain interference).
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4 weeks
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Hospital Anxiety and Depression Scale
기간: 4 weeks
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Measures: 1) Anxiety (sum of 7 items; ranges from 0-21, with higher scores indicating greater anxiety), and 2) Depression (sum of 7 items; ranges from 0-21, with higher scores indicating greater depressive symptoms).
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4 weeks
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Mindful Attention Awareness Scale
기간: 4 weeks
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Measures mindfulness; mean of 15 items (ranges from 1 to 6, with higher scores indicating greater levels of mindfulness)
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4 weeks
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Schwartz Outcome Scale
기간: 4 weeks
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Measures general well-being; sum of 10 items (ranges from 0 to 60, with higher scores indicating greater well-being)
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4 weeks
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Toronto Mindfulness Scale-Decentering Subscale
기간: 1 hour
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Measures decentering; sum of 7 items (higher scores indicate greater levels of decentering)
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1 hour
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Opioid Compliance Checklist
기간: 4 weeks
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Measure misuse of opioid medications (scores range from 0 to 12, with higher scoring indicating greater misuse)
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4 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
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
- 2018-0864
- A532007 (기타 식별자: UW Madison)
- SMPH/FAMILY MED/RES GRANTS (기타 식별자: UW Madison)
- Protocol Version 6/25/2018 (기타 식별자: UW Madison)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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