跳至主要内容
临床试验/NCT02971865
NCT02971865已完成不适用

Effect of Manual Medicine or Cognitive Behavioral Therapy With Chronic Uncontrolled Diabetes Within a Shared Primary Care Visit (A Randomized Clinical Trial)

Community Wellness Center, West Linn, OR1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
hemoglobin A1c

研究概览

简要总结

Effects of manual medicine or cognitive behavioral therapy with chronic uncontrolled diabetes within a shared primary care visit. An evaluation of the effectiveness of manual therapy vs cognitive behavioral therapy (CBT) vs traditional primary care visit care is in need.

详细描述

Integrating cognitive behavioral health nutritional therapy (hereafter CBT) and primary care services plays an important role in healthcare outcomes and the prevalence of chronic disorders treated in primary care. The Center of Disease Control has published some disturbing numbers: 9.3% of the U.S. population is affected by diabetes. Ninety-five percent of these individuals will receive treatment from their primary care provider, less than 5% will consult with a dietitian or behavioral health provider. Diabetes is projected to triple in the US despite numerous treatment options and greatly increased medical resources devoted to this problem. There is need for treatments that demonstrate an effectiveness that is low risk and wide spread.

A person's state of mind can play an important role in physical and psychosocial health conditions such as diabetes. Depression and diabetes share a bidirectional association. A recent meta-analysis reported that depressed individuals have a 60% increased risk of developing diabetes. An association was found between the risks of developing diabetes and non-severe depression, persistent depression, and untreated depression. Cognitive behavioral therapy, among others, has demonstrated effectiveness for a variety of chronic conditions.

By implementing a shared visit with primary care we encourage the advancement of this new approach. A focus on stress reduction by using mindfulness to encourage patients to think of their body as a whole and heal through not only the use of CBT, but with nutrition and manual therapy. Demonstrating the beneficial effects CBT has on uncontrolled diabetes will offer another psychosocial treatment option for the large number of suffering US residents. CBT and other mindfulness-based interventions have been recognized as helpful for a range of conditions including chronic pain. However, only 1 large randomized clinical trial (RCT) has evaluated CBT for chronic low back pain, and that trial was limited to older adults.

This clinical trial also includes chiropractic manipulative treatment (CMT) with uncontrolled diabetes patients. This study is unique due to the lack of any pre-existing trials of this nature. CMT has demonstrated improvement in physical function. A compromise of the peripheral nervous system is a common long-term complication of diabetes. In severe cases, this can lead to limb amputations and sudden cardiac death secondary to autonomic polyneuropathy. Proper recognition of the musculoskeletal manifestations of patients with diabetes will aid the treating chiropractor and alert them to the possible neurological consequences of diabetes.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Hemoglobin A1c above 9%

排除标准

  • •0-18 years old

研究组 & 干预措施

CBT/CMT

Experimental

The CBT/CMT program does not focus specifically on a particular condition such as diabetes. All treatment included patient education on nutrition content and mindfulness practice (emotions, and sensations in the present moment without trying to change them, awareness of breathing, and social economic problems) with manual therapy.

干预措施: CBT/CMT (Behavioral)

traditional primary care visit

Active Comparator

Provide high quality primary care for men, women, and children of all ages. Our providers work together to ensure that you receive the most comprehensive care possible. Primary care is described as the medical setting in which patients receive most of their medical care and, therefore, is typically their first source for treatment

干预措施: Control group traditional primary care (Other)

结局指标

主要结局

hemoglobin A1c

时间窗: One year

lab values (\[hemoglobin A1c\]; range, 1-20%

Consumer Assessment of Healthcare Providers and Systems (CAHPS)

时间窗: One year

31 questions with three categories version 3.0 done at one year

次要结局

  • Patient Health Questionnaire-9 (PHQ-9(One year)

研究者

发起方
Community Wellness Center, West Linn, OR
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ryan Bellacov

Chairman of the board

Community Wellness Center, West Linn, OR

研究点 (1)

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