Evaluating a Primary-Care Group-based Mindfulness Program

NCT03662581 | Terminated

• 1 other identifier: Group-based Mindfulness
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression; Sleep Initiation and Maintenance Disorders; Social Isolation

Keywords

Generalized anxiety disorder; Mental health; Mindfulness; Group-based therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient Heath Questionnaire 9 (PHQ-9) for depression

  Change from baseline each week until 8 weeks and at 8 months post-baseline

• Insomnia Severity Index (ISI)

  Change from baseline each week until 8 weeks and at 8 months post-baseline

• DeJong Gierveld Loneliness Scale

  Change from baseline each week until 8 weeks and at 8 months post-baseline

Other Outcomes (2)

• Hemoglobin A1C (HgA1C)

  Change from baseline at 8 weeks and at 8 months post-baseline

• Weight

  Change from baseline at 8 weeks and at 8 months post-baseline

Study Arms (1)

Mindfulness Group Program

EXPERIMENTAL

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

Interventions

Mindfulness Group Program BEHAVIORAL

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

Mindfulness Group Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

Ajax Harwood Clinic

Ajax, Ontario, L1S 2H6, Canada

Location

Related Publications (8)

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 28088111 BACKGROUND

• 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.

  PMID: 17339617 BACKGROUND

• 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.

  PMID: 26951403 BACKGROUND

• 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.

  PMID: 15550799 BACKGROUND

• 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.

  PMID: 11438246 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 27932403 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Sleep Initiation and Maintenance Disorders; Social Isolation; Generalized Anxiety Disorder; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Social Behavior; Personal Satisfaction

Study Officials

• Yaswanta Gummadi, BHSc

  McMaster University

  PRINCIPAL INVESTIGATOR

• Elizabeth Alvarez, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 7, 2018
• Study Start: November 30, 2018
• Primary Completion: May 30, 2020
• Study Completion: December 30, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)