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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971865
• Other study ID #: 1000CWC
• Status: Completed
• Phase: N/A
• First received: November 14, 2016
• Last updated: November 20, 2016
• Start date: June 2015
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: Community Wellness Center, West Linn, OR
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Hemoglobin A1c above 9%

Exclusion Criteria:

• 0-18 years old

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• CBT/CMT
Cognitive Behavioral Therapy (CBT - training to change nutritional thoughts and behaviors) and Chiropractic Manipulative Therapy (CMT - High Velocity, low amplitude chiropractic manipulation) were delivered in average total 8 visits in a year. The interventions were comparable in format (individual visit), duration (30 minute visits), frequency (monthly), and number of participants per group (see intervention details). Each intervention was delivered according to a protocol in which all instructors were trained. (Figure 3: Chiropractic/Behavioral health and Primary care Integration Protocol.) Routine care varied with patient complaints at the time of visit.

Other:
• Control group traditional primary care
No change in care usually given

Locations

Country	Name	City	State
United States	Community Wellness Center	West Linn	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Community Wellness Center, West Linn, OR

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mezuk B, Eaton WW, Albrecht S, Golden SH. Depression and type 2 diabetes over the lifespan: a meta-analysis. Diabetes Care. 2008 Dec;31(12):2383-90. doi: 10.2337/dc08-0985. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin A1c	lab values ([hemoglobin A1c]; range, 1-20%	One year	Yes
Primary	Consumer Assessment of Healthcare Providers and Systems (CAHPS)	31 questions with three categories version 3.0 done at one year	One year	No
Secondary	Patient Health Questionnaire-9 (PHQ-9	PHQ-9; range, 0-27; higher scores indicate greater severity).15 The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. 14 The PHQ-9 is the depression module, which scores each of the 9 Diagnostic and Statistical Manual of Mental Disorders (DSM) -IV criteria as "0" (not at all) to "3" (nearly every day).	One year	No