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临床试验/NCT02262377
NCT02262377已完成不适用

Integrative Medicine Group Visits: A Patient-Centered Approach to Reducing Chronic Pain and Depression in a Disparate Urban Population

Boston Medical Center2 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2015年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
159
试验地点
2
主要终点
Chronic Pain

研究概览

简要总结

The purpose of this study is to determine whether Integrative Medicine Group Visits (IMGV) are effective for treating patients with chronic pain and depression.

详细描述

The investigators propose a randomized controlled comparative effectiveness trial for patients from predominantly low-income minority backgrounds with chronic pain and depressive symptoms comparing two treatment groups: (1) A standardized, 9-session Integrative Medicine Group Visits (IMGV) protocol; (2) primary care visits including medications and provider's advice. The trial will take place at three sites: Boston Medical Center's Family Medicine Center and two affiliated federally qualified community health centers.

Patients at the three sites can self-refer or with their permission, their clinician can forward their information via email, an electronic flag or phone call to research staff. Following verbal consent, patients will be screened for eligibility by a Research Assistant either over the phone or in person. Eligible participants will then have the study explained to them by the Research Assistant and will be offered an opportunity to ask questions about the study and then invited to provide informed consent. Those participants who consent to participate will provide contact information for themselves and two additional contacts to assist with follow-up. They will then complete the baseline data survey which will consist of questionnaires on topics such as stress, pain, sleep, self-efficacy, social support, diet, exercise, relaxation, and use of pain medications. These will be administered on a tablet by a Research Assistant and should take no more than one hour to complete. Once the baseline measures have been completed, participants will be randomized to either the intervention or control condition. Once randomized, participants' clinicians will be notified via phone call, letter or email that their patient is enrolled in the study.

INTERVENTION GROUP Integrative Medicine Group Visits (IMGV)

The intervention is adapted from Mindfulness Based Stress Reduction (MBSR). For this study, those randomized to the intervention group will be asked to attend nine consecutive group visits (once a week) and a follow-up group visit at 12 weeks after the last session. During the session, a physician and co-leader facilitate each groups. Participants are taught and practice relaxation techniques at each class. The physician facilitates a discussion on health topics important to the group participants on chronic disease management, such as prevention and management of pain and associated conditions (stress re-activity, insomnia, obesity, hypertension etc.). Patients are also introduced to evidenced based complementary activities such as self-massage techniques, acupressure, and cooking classes. Finally, an optional healthy meal is served each week, creating an opportunity to model healthy nutrition and build community. Individuals randomized to IMGV will continue to receive routine medical care, including pain medications, from their primary care providers (PCPs).

Individual time spent with the group visit physician - Depending on the individual patient and his/her needs. The IMGV physician facilitator will communicate with the participants' PCPs (via electronic medical record or phone) throughout the intervention to give updates on the activities and progress of the patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • self-reported chronic pain for at least 12 weeks
  • average pain intensity for the previous week >4 on a 0 to 10 numerical rating scale; PHQ-9 score >5, indicating minor depression or greater
  • English fluency sufficient to follow treatment instructions and answer survey questions.

排除标准

  • previous participation in IMGV
  • new pain treatments in past month or anticipated to begin in next 3 months
  • active or planned worker's compensation, disability, or personal injury claims
  • known or planned pregnancy
  • manic symptoms
  • active suicidality
  • psychotic symptoms

研究组 & 干预措施

Integrative Medicine Group Visits

Experimental

9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting

干预措施: Integrative Medicine Group Visits (Behavioral)

Standard of Care

No Intervention

primary care visits, which include medications and advice

结局指标

主要结局

Chronic Pain

时间窗: This was conducted at 21 weeks.

Chronic pain reflects the average scores for the severity, interference and average pain subscales from the Brief Pain Inventory (BPI) Short Form (BPI-sf). BPI-sf is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on their daily functioning on a 10 point scale from 0 to 10 where higher scores indicate higher levels of pain. Average pain was obtained by asking the participant's what their average pain was in the past 7 days. Pain interference was calculated by adding the scores for questions 8a, b, c, d, e, f, and g and then dividing by seven. Pain severity was calculated by adding the scores for questions 2, 3, 4, and 5 and then by dividing by four. The average score for each subscale was obtained by adding all respective scores and then dividing each subscale total by the total number of participants.

Depression

时间窗: This was conducted at 21 weeks.

Patient Health Questionnaire (PHQ-9) measures severity of depressive symptoms. It is a sum of 9 items each with a 0-3 units on a scale. Higher scores indicate higher levels of depression. A score of 0-4 is considered minimal or none in depression severity. A score of 5-9 is considered mild in depression severity. A score of 10-14 is considered moderate in depression severity. A score of 15-19 is considered moderately severe in depression severity. A score of 20-27 is considered severe in depression severity. (Kroenke 2009) This was conducted at 21 weeks.

Pain Self Efficacy Scale

时间窗: This was conducted at 21 weeks.

Pain Self Efficacy Questionnaire (PSEQ) - used to assess the confidence in performing activities while in pain. It is the sum of 10 items each with a 0-6 scale. Scores range from 0-60 and is done by simple addition. Higher scores indicate higher levels of confidence. (Nicholas 2007) This was conducted at 21 weeks.

Pain Medication Use

时间窗: This was conducted at 21 weeks.

Number of participants reported pain medication in the past seven day. This was obtained at 21 weeks.

次要结局

  • Emergency Department Use(This was collected at 21 weeks.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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