<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02971865</url>
  </required_header>
  <id_info>
    <org_study_id>1000CWC</org_study_id>
    <nct_id>NCT02971865</nct_id>
  </id_info>
  <brief_title>Effect of Manual Medicine or Cognitive Behavioral Therapy With Chronic Uncontrolled Diabetes</brief_title>
  <official_title>Effect of Manual Medicine or Cognitive Behavioral Therapy With Chronic Uncontrolled Diabetes Within a Shared Primary Care Visit (A Randomized Clinical Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Community Wellness Center, West Linn, OR</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Community Wellness Center, West Linn, OR</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Effects of manual medicine or cognitive behavioral therapy with chronic uncontrolled diabetes&#xD;
      within a shared primary care visit. An evaluation of the effectiveness of manual therapy vs&#xD;
      cognitive behavioral therapy (CBT) vs traditional primary care visit care is in need.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Integrating cognitive behavioral health nutritional therapy (hereafter CBT) and primary care&#xD;
      services plays an important role in healthcare outcomes and the prevalence of chronic&#xD;
      disorders treated in primary care. The Center of Disease Control has published some&#xD;
      disturbing numbers: 9.3% of the U.S. population is affected by diabetes. Ninety-five percent&#xD;
      of these individuals will receive treatment from their primary care provider, less than 5%&#xD;
      will consult with a dietitian or behavioral health provider. Diabetes is projected to triple&#xD;
      in the US despite numerous treatment options and greatly increased medical resources devoted&#xD;
      to this problem. There is need for treatments that demonstrate an effectiveness that is low&#xD;
      risk and wide spread.&#xD;
&#xD;
      A person's state of mind can play an important role in physical and psychosocial health&#xD;
      conditions such as diabetes. Depression and diabetes share a bidirectional association. A&#xD;
      recent meta-analysis reported that depressed individuals have a 60% increased risk of&#xD;
      developing diabetes. An association was found between the risks of developing diabetes and&#xD;
      non-severe depression, persistent depression, and untreated depression. Cognitive behavioral&#xD;
      therapy, among others, has demonstrated effectiveness for a variety of chronic conditions.&#xD;
&#xD;
      By implementing a shared visit with primary care we encourage the advancement of this new&#xD;
      approach. A focus on stress reduction by using mindfulness to encourage patients to think of&#xD;
      their body as a whole and heal through not only the use of CBT, but with nutrition and manual&#xD;
      therapy. Demonstrating the beneficial effects CBT has on uncontrolled diabetes will offer&#xD;
      another psychosocial treatment option for the large number of suffering US residents. CBT and&#xD;
      other mindfulness-based interventions have been recognized as helpful for a range of&#xD;
      conditions including chronic pain. However, only 1 large randomized clinical trial (RCT) has&#xD;
      evaluated CBT for chronic low back pain, and that trial was limited to older adults.&#xD;
&#xD;
      This clinical trial also includes chiropractic manipulative treatment (CMT) with uncontrolled&#xD;
      diabetes patients. This study is unique due to the lack of any pre-existing trials of this&#xD;
      nature. CMT has demonstrated improvement in physical function. A compromise of the peripheral&#xD;
      nervous system is a common long-term complication of diabetes. In severe cases, this can lead&#xD;
      to limb amputations and sudden cardiac death secondary to autonomic polyneuropathy. Proper&#xD;
      recognition of the musculoskeletal manifestations of patients with diabetes will aid the&#xD;
      treating chiropractor and alert them to the possible neurological consequences of diabetes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>hemoglobin A1c</measure>
    <time_frame>One year</time_frame>
    <description>lab values ([hemoglobin A1c]; range, 1-20%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Consumer Assessment of Healthcare Providers and Systems (CAHPS)</measure>
    <time_frame>One year</time_frame>
    <description>31 questions with three categories version 3.0 done at one year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9 (PHQ-9</measure>
    <time_frame>One year</time_frame>
    <description>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 &quot;0&quot; (not at all) to &quot;3&quot; (nearly every day).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>CBT/CMT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>traditional primary care visit</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT/CMT</intervention_name>
    <description>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.</description>
    <arm_group_label>CBT/CMT</arm_group_label>
    <other_name>Cognitive Behavioral Therapy</other_name>
    <other_name>Chiropractic Manipulative Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group traditional primary care</intervention_name>
    <description>No change in care usually given</description>
    <arm_group_label>traditional primary care visit</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Hemoglobin A1c above 9%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  0-18 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Community Wellness Center</name>
      <address>
        <city>West Linn</city>
        <state>Oregon</state>
        <zip>97068</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>19033418</PMID>
  </results_reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 20, 2016</last_update_submitted>
  <last_update_submitted_qc>November 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Community Wellness Center, West Linn, OR</investigator_affiliation>
    <investigator_full_name>Ryan Bellacov</investigator_full_name>
    <investigator_title>Chairman of the board</investigator_title>
  </responsible_party>
  <keyword>Cognitive Behavior Therapy</keyword>
  <keyword>Chiropractic</keyword>
  <keyword>Diabetes Mellitus, Type 2</keyword>
  <keyword>Primary care shared visit</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02971865
org study id: 1000CWC
nct id: NCT02971865
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: hemoglobin A1c
time frame: One year
description: lab values ([hemoglobin A1c]; range, 1-20%
measure: Consumer Assessment of Healthcare Providers and Systems (CAHPS)
time frame: One year
description: 31 questions with three categories version 3.0 done at one year
measure: Patient Health Questionnaire-9 (PHQ-9
time frame: One year
description: 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).
arm group label: CBT/CMT
arm group type: Experimental
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.
arm group label: traditional primary care visit
arm group type: Active Comparator
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
intervention type: Behavioral
intervention name: CBT/CMT
description: 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.
arm group label: CBT/CMT
other name: Cognitive Behavioral Therapy
other name: Chiropractic Manipulative Therapy
intervention type: Other
intervention name: Control group traditional primary care
description: No change in care usually given
arm group label: traditional primary care visit
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: 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.
PMID: 19033418
responsible party type: Principal Investigator
investigator affiliation: Community Wellness Center, West Linn, OR
investigator full name: Ryan Bellacov
investigator title: Chairman of the board
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Yes
ipd description: 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.