Diabetes Mellitus, Type 2NCT02971865
Effect of Manual Medicine or Cognitive Behavioral Therapy With Chronic Uncontrolled Diabetes
A study testing CBT/CMT in people with Diabetes Mellitus, Type 2, run by Community Wellness Center, West Linn, OR at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- CBT/CMT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hemoglobin A1c above 9%
Who cannot join
- 0-18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Manual Medicine or Cognitive Behavioral Therapy With Chronic Uncontrolled Diabetes Within a Shared Primary Care Visit (A Randomized Clinical Trial)
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.
Read the detailed 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- CBT/CMT, Control group traditional primary care
- Keywords
- Cognitive Behavior Therapy, Chiropractic, Diabetes Mellitus, Type 2, Primary care shared visit
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT/CMTBehavioural
Also called Cognitive Behavioral Therapy, Chiropractic Manipulative Therapy
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.
Control group traditional primary careOther
No change in care usually given
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CBT/CMT |
| 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 Receives: Other: Control group traditional primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin A1c
lab values ([hemoglobin A1c]; range, 1-20%
Measured: One year
Consumer Assessment of Healthcare Providers and Systems (CAHPS)
31 questions with three categories version 3.0 done at one year
Measured: One year
Secondary outcomes (1)
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).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startJun 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Community Wellness Center, West Linn, OR
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Bellacov, Community Wellness Center, West Linn, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971865
- Sponsor's protocol ID
- 1000CWC
- Status last verified
- Nov 2016
- First submitted
- 14 Nov 2016
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Plan to share individual participant data with other researchers via Journal of Manipulative and Physiological Therapeutics (JMPT). Also, annual collaborative of primary care providers in Oregon.
Publications
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.
PubMed 19033418
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Manual Medicine or Cognitive Behavioral Therapy With Chronic Uncontrolled Diabetes Within a Shared Primary Care Visit (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT02971865
- Acronym / sponsor ID
- 1000CWC
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Cognitive Behavior Therapy, Chiropractic, Diabetes Mellitus, Type 2, Primary care shared visit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Community Wellness Center, West Linn, ORUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT/CMT | Experimental | Behavioral: CBT/CMTThe 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. |
| traditional primary care visit | Active comparator | Other: Control group traditional primary careProvide 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hemoglobin A1c above 9%
Key exclusion criteria (1 listed)
- 0-18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT/CMTAlso: Cognitive Behavioral Therapy, Chiropractic Manipulative TherapyCognitive 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. | Behavioural | CBT/CMT |
| Control group traditional primary careNo change in care usually given | Other | traditional primary care visit |
Primary outcome
hemoglobin A1c
Time frame: One year
lab values ([hemoglobin A1c]; range, 1-20%
Consumer Assessment of Healthcare Providers and Systems (CAHPS)
Time frame: One year
31 questions with three categories version 3.0 done at one year
1 secondary outcome
Patient Health Questionnaire-9 (PHQ-9
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
- Results publication: PubMed 19033418Mezuk 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.
- Individual participant dataSharing planned: Yes. Plan to share individual participant data with other researchers via Journal of Manipulative and Physiological Therapeutics (JMPT). Also, annual collaborative of primary care providers in Oregon.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT/CMT in people with Diabetes Mellitus, Type 2, run by Community Wellness Center, West Linn, OR at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemoglobin A1c (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02971865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2016.