Evaluating a Primary-Care Group-based Mindfulness Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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 To capitalize on the power of groups to: Foster peer-to-peer learning and support when it comes to coping with life challenges Combat isolation 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.

Official Title
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Evaluating a Primary-Care Group-based Mindfulness Program

Conditions
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Anxiety, Depression, Sleep Initiation and Maintenance Disorders, Social Isolation

Intervention / Treatment
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* Behavioral: Mindfulness Group Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Group Program<br>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<br>* 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: Foster peer-to-peer learning and support when it comes to coping with life challenges Combat isolation Increase efficiency, quality, and timeliness of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalized Anxiety Disorder - 7 (GAD-7) | 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). | Change from baseline each week until 8 weeks and at 8 months post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Heath Questionnaire 9 (PHQ-9) for depression | 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. | Change from baseline each week until 8 weeks and at 8 months post-baseline | 
| Insomnia Severity Index (ISI) | 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) | Change from baseline each week until 8 weeks and at 8 months post-baseline | 
| DeJong Gierveld Loneliness Scale | 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). | Change from baseline each week until 8 weeks and at 8 months post-baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Generalized anxiety disorder, Mental health, Mindfulness, Group-based therapy