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Evaluating a Primary-Care Group-based Mindfulness Program

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ClinicalTrials.gov Identifier: NCT03662581
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Elizabeth Alvarez, McMaster University

Brief Summary:
The study evaluates the effectiveness of a group-based mindfulness program conducted in a primary care setting. This study also aims to identify any scale-up and implementation considerations for the program.

Condition or disease Intervention/treatment Phase
Anxiety Depression Sleep Initiation and Maintenance Disorders Social Isolation Behavioral: Mindfulness Group Program Not Applicable

Detailed Description:

A primary care group-based mindfulness program was developed by community physicians and co-op and public health students in Ajax, Ontario. The program was started in January 2018 and is run through the Ajax Harwood Clinic, which is a clinic housing a Family Health Organization (FHO) comprising of 5 physicians and approximately 6,500 patients. The purposes of the program are:

  1. To teach mindfulness skills for stress reduction, self-compassion, and dealing with difficult thoughts and emotions,
  2. To promote an integrative concept of health, which treats the whole person
  3. To promote community building and positive relationships
  4. To capitalize on the power of groups to:

    1. Foster peer-to-peer learning and support when it comes to coping with life challenges
    2. Combat isolation
    3. Increase efficiency, quality, and timeliness of care

This study evaluates the 8-week rolling admission mindfulness program, by first doing a retrospective chart review to identify effect sizes and then conducting a before-after study evaluation of the effect of the mindfulness program on key mental health outcome measures.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This study evaluates the effect of the intervention using a single group, before-after study model. The subjects will be evaluated at baseline and followed longitudinally, until study completion and a long-term followup.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating a Primary-Care Group-based Mindfulness Program
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Mindfulness Group Program
A primary care mindfulness-based rolling admissions program where subjects must attend 4 of 8 consecutive group sessions, to be considered to have completed the program.
Behavioral: Mindfulness Group Program

The mindfulness program has the following aims (Iacono, 2018): to teach mindfulness skills for stress reduction, self-compassion, and dealing with difficult thoughts and emotions, to promote an integrative concept of health, which treats the whole person, to promote community building and positive relationships, and to capitalize on the power of groups to:

  1. Foster peer-to-peer learning and support when it comes to coping with life challenges
  2. Combat isolation
  3. Increase efficiency, quality, and timeliness of care




Primary Outcome Measures :
  1. Generalized Anxiety Disorder - 7 (GAD-7) [ Time Frame: Change from baseline each week until 8 weeks and at 8 months post-baseline ]
    The GAD-7 is a validated instrument for the diagnosis and treatment response of anxiety disorders (Spitzer et al, 2006; Hinz et al, 2017). It is comprised of 7 questions with 4 answer options, ranging from "not at all" to "nearly every day" and scored 0-3 with a total score ranging from 0-21 (Spitzer et al, 2006). Scores of 5-9, 10-14, and 15-21 represent mild, moderate and severe generalized anxiety disorder, respectively. In the primary care setting, the GAD-7 has high diagnostic validity, with a threshold of 10 exhibiting a sensitivity of 89% and specificity of 82% for generalized anxiety disorder (Spitzer et al, 2006). Other conditions related to generalized anxiety disorder including panic disorder, social anxiety disorder and post-traumatic stress disorder have also been sensitive to a GAD-7 score of 10 (Kroenke et al, 2007).


Secondary Outcome Measures :
  1. Patient Heath Questionnaire 9 (PHQ-9) for depression [ Time Frame: Change from baseline each week until 8 weeks and at 8 months post-baseline ]
    The Patient Health Questionnaire-9 (PHQ-9) is made up of nine questions and is diagnostic for depression. Importantly, the PHQ-9 has also been found to be sensitive to change for monitoring of treatment outcomes (Kohrt et al, 2016; Lowe et al, 2004). The PHQ-9 asks participants, "Over the last 2 weeks, how often have you been bothered by any of the following problems?" All answers have four options ranging from "not at all," "several days," more than half the days," or "nearly every day" for a number of symptoms related to depression. Major depression and other depressive syndromes are diagnosed based on answers of "more than half the days" or "nearly every day" to "Little interest or pleasure in doing things" or "Feeling down, depressed, or hopeless" plus 2-5 or more of the other symptoms.

  2. Insomnia Severity Index (ISI) [ Time Frame: Change from baseline each week until 8 weeks and at 8 months post-baseline ]

    The Insomnia Severity Index, a 7-item scale, was identified as the most fitting validated scale to identify insomnia symptoms (Bastien et al., 2001). Each of the questions is measured on a scale of 0-4 and the answers are added up to get a total score.

    Total score categories:

    0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)


  3. DeJong Gierveld Loneliness Scale [ Time Frame: Change from baseline each week until 8 weeks and at 8 months post-baseline ]
    The DeJong Gierveld 6-item Loneliness Scale captures both emotional loneliness (missing an intimate relationship) and social loneliness (missing a wider social network) (Gierveld et al, 2006; Grygiel et al, 2016). Each subscale is made up of three questions with possible answers of "yes," "more or less," or "no." Questions 1-3 are negatively worded and answers of "yes" or "more or less" are scored as "1", while "no" is scored as "0". On positively worded questions (4-6), neutral or negative answers ("no" or "more or less") are scored as "1," while "yes" is scored as "0." This gives a range of 0 (not lonely)-3 (very lonely) in each subscale, or 0 (not lonely)-6 (very lonely) in the total scale. However, we have changed this scoring so that we can further discriminate between neutral and other answers. Therefore, our scoring on each question ranges from 0-2, giving a total scale of 0 (not lonely)-12 (very lonely).


Other Outcome Measures:
  1. Hemoglobin A1C (HgA1C) [ Time Frame: Change from baseline at 8 weeks and at 8 months post-baseline ]
    Assessing prevalence of diabetes via HgA1C levels from electronic medical record (EMR) for comorbidity comparison

  2. Weight [ Time Frame: Change from baseline at 8 weeks and at 8 months post-baseline ]
    Assessing prevalence of obesity/comorbidities from weight through EMR data



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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:

  • Be enrolled in mindfulness-based program through Ajax Harwood Clinic
  • Age of 18
  • English-speaking ability to participate in program
  • Able to provide informed consent

Exclusion Criteria:

  • no formal exclusion criteria

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): NCT03662581


Contacts
Contact: Elizabeth Alvarez, MD (905) 525-9140 ext 22248 alvare@mcmaster.ca
Contact: Yaswanta Gummadi, BHSc 289-808-2158 gummadiy@mcmaster.ca

Locations
Canada, Ontario
Ajax Harwood Clinic Recruiting
Ajax, Ontario, Canada, L1S 2H6
Contact: Carlos Yu, MD    905-683-0690    c.yu765@hotmail.com   
Principal Investigator: Yaswanta Gummadi, BHSc         
Principal Investigator: Elizabeth Alvarez, MD,MPH,PhD         
Sub-Investigator: Anita Iacono, BSc         
Sub-Investigator: Sarah MacDonald, BSc         
Sub-Investigator: Carlos Yu, MD         
Sub-Investigator: Japteg Singh, BSc         
Sub-Investigator: Arielle Sutton, BSc         
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: Yaswanta Gummadi, BHSc McMaster University
Principal Investigator: Elizabeth Alvarez, MD McMaster University

Additional Information:
Publications:
Gierveld, J. D. J., & Tilburg, T. V. (2006). A 6-Item Scale for Overall, Emotional, and Social Loneliness: Confirmatory Tests on Survey Data. Research on Aging, 28(5), 582-598. https://doi.org/10.1177/0164027506289723

Responsible Party: Elizabeth Alvarez, Assistant Professor, McMaster University
ClinicalTrials.gov Identifier: NCT03662581     History of Changes
Other Study ID Numbers: Group-based Mindfulness
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elizabeth Alvarez, McMaster University:
Generalized anxiety disorder
Mental health
Mindfulness
Group-based therapy

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders