Clinical trial NCT03662581: Evaluating a Primary-Care Group-based Mindfulness Program
Official title: Evaluating a Primary-Care Group-based Mindfulness Program
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety
Depression
Sleep Initiation and Maintenance Disorders
Social Isolation
Keywords: Generalized anxiety disorder
Mental health
Mindfulness
Group-based therapy
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Generalized Anxiety Disorder - 7 (GAD-7)
timeFrame: Change from baseline each week until 8 weeks and at 8 months post-baseline
Secondary outcomes:
measure: Patient Heath Questionnaire 9 (PHQ-9) for depression
timeFrame: Change from baseline each week until 8 weeks and at 8 months post-baseline
measure: Insomnia Severity Index (ISI)
timeFrame: Change from baseline each week until 8 weeks and at 8 months post-baseline
measure: DeJong Gierveld Loneliness Scale
timeFrame: Change from baseline each week until 8 weeks and at 8 months post-baseline
Other outcomes:
measure: Hemoglobin A1C (HgA1C)
timeFrame: Change from baseline at 8 weeks and at 8 months post-baseline
measure: Weight
timeFrame: Change from baseline at 8 weeks and at 8 months post-baseline
Locations:
city: Ajax
country: Canada
facility: Ajax Harwood Clinic
state: Ontario
Study officials:
affiliation: McMaster University
name: Yaswanta Gummadi, BHSc
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Elizabeth Alvarez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
citation: Hinz A, Klein AM, Brahler E, Glaesmer H, Luck T, Riedel-Heller SG, Wirkner K, Hilbert A. Psychometric evaluation of the Generalized Anxiety Disorder Screener GAD-7, based on a large German general population sample. J Affect Disord. 2017 Mar 1;210:338-344. doi: 10.1016/j.jad.2016.12.012. Epub 2016 Dec 18.
citation: Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.
citation: Kohrt BA, Luitel NP, Acharya P, Jordans MJ. Detection of depression in low resource settings: validation of the Patient Health Questionnaire (PHQ-9) and cultural concepts of distress in Nepal. BMC Psychiatry. 2016 Mar 8;16:58. doi: 10.1186/s12888-016-0768-y.
citation: Lowe B, Unutzer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care. 2004 Dec;42(12):1194-201. doi: 10.1097/00005650-200412000-00006.
citation: Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
citation: 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
citation: Grygiel P, Humenny G, Rebisz S. Using the De Jong Gierveld Loneliness Scale With Early Adolescents: Factor Structure, Reliability, Stability, and External Validity. Assessment. 2019 Mar;26(2):151-165. doi: 10.1177/1073191116682298. Epub 2016 Dec 8.