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Completed

NCT Number: NCT02971865

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Wellness Center

West Linn, Oregon, 97068, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Hemoglobin A1c above 9%

Exclusion criteria

  • 0-18 years old

Treatment and study plan

CBT/CMT

Behavioral

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 names: Cognitive Behavioral Therapy, Chiropractic Manipulative Therapy

Control group traditional primary care

Other

No change in care usually given

Primary outcomes

  1. hemoglobin A1c

    Time frame: One year

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

  2. Consumer Assessment of Healthcare Providers and Systems (CAHPS)

    Time frame: One year

    31 questions with three categories version 3.0 done at one year

Secondary outcomes

  1. Patient Health Questionnaire-9 (PHQ-9

    Time frame: One year

    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).

Sponsors and collaborators

Lead sponsor

Community Wellness Center, West Linn, OR

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 23, 2016
Registry last updated
Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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