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Integrative Medicine Group Visits: A Patient-Centered Approach to Reducing Chronic Pain and Depression (IMGV)

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ClinicalTrials.gov Identifier: NCT02262377
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Paula Gardiner, Boston Medical Center

Brief Summary:
The purpose of this study is to determine whether Integrative Medicine Group Visits (IMGV) are effective for treating patients with chronic pain and depression.

Condition or disease Intervention/treatment Phase
Chronic Pain Depression Behavioral: Integrative Medicine Group Visits Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrative Medicine Group Visits: A Patient-Centered Approach to Reducing Chronic Pain and Depression in a Disparate Urban Population
Study Start Date : April 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Integrative Medicine Group Visits
9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting
Behavioral: Integrative Medicine Group Visits
Patients with chronic pain and depression attend group medical visits and use website and virtual patient advocate as part of the curriculum.

No Intervention: Standard of Care
primary care visits, which include medications and advice



Primary Outcome Measures :
  1. Chronic Pain [ Time Frame: 21 weeks ]
    Brief Pain Inventory

  2. Depression [ Time Frame: 21 weeks ]
    PHQ-9 survey


Secondary Outcome Measures :
  1. Pain Self Efficacy Scale [ Time Frame: 21 weeks ]
    Pain Self Efficacy Scale Survey

  2. Pain Medication Use [ Time Frame: 21 weeks ]
    COMM


Other Outcome Measures:
  1. Patient Activation Measure [ Time Frame: 21 weeks ]
    PAM13

  2. Stress Level [ Time Frame: 21 weeks ]
    Perceived Stress Scale -4

  3. Sleep [ Time Frame: 21 weeks ]
    Pittsburgh Sleep Inventory

  4. Dietary Patterns [ Time Frame: 21 weeks ]
    Nutrition Survey

  5. Physical Activity [ Time Frame: 21 weeks ]
    Exercise Survey



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • self-reported chronic pain for at least 12 weeks
  • average pain intensity for the previous week >4 on a 0 to 10 numerical rating scale; PHQ-9 score >5, indicating minor depression or greater
  • English fluency sufficient to follow treatment instructions and answer survey questions.

Exclusion Criteria:

  • previous participation in IMGV
  • new pain treatments in past month or anticipated to begin in next 3 months
  • active or planned worker's compensation, disability, or personal injury claims
  • known or planned pregnancy
  • manic symptoms
  • active suicidality
  • psychotic symptoms
  • no PCP

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02262377


Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Paula Gardiner, MD, MPH Boston Medical Center

Additional Information:
Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paula Gardiner, Assistant Professor, Boston Medical Center
ClinicalTrials.gov Identifier: NCT02262377     History of Changes
Other Study ID Numbers: H-33096
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

Keywords provided by Paula Gardiner, Boston Medical Center:
Group Medical Visits
Integrative Medicine
Chronic Pain
Depression
MBSR
Mindfulness Based Stress Reduction
Web based
Virtual Patient Advocate
Internet Based

Additional relevant MeSH terms:
Depression
Depressive Disorder
Chronic Pain
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms