Effect of Manual Medicine or Cognitive Behavioral Therapy With Chronic Uncontrolled Diabetes

Community Wellness Center, West Linn, OR

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: CBT/CMT; Other: Control group traditional primary care

Study type: Interventional

Funder types: Other

Identifiers

NCT02971865

1000CWC

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Hemoglobin A1c above 9%

Exclusion criteria

• 0-18 years old

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups

CBT/CMT

Experimental group

Description:

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.

Treatment:

Behavioral: CBT/CMT

traditional primary care visit

Active Comparator group

Description:

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

Treatment:

Other: Control group traditional primary care