Evaluating a Primary-Care Group-based Mindfulness Program
2. April 2021 aktualisiert von: Elizabeth Alvarez, McMaster University
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.
Studienübersicht
Status
Beendet
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
80
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Ontario
-
Ajax, Ontario, Kanada, L1S 2H6
- Ajax Harwood Clinic
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
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:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Generalized Anxiety Disorder - 7 (GAD-7)
Zeitfenster: 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).
|
Change from baseline each week until 8 weeks and at 8 months post-baseline
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Patient Heath Questionnaire 9 (PHQ-9) for depression
Zeitfenster: 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.
|
Change from baseline each week until 8 weeks and at 8 months post-baseline
|
|
Insomnia Severity Index (ISI)
Zeitfenster: 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) |
Change from baseline each week until 8 weeks and at 8 months post-baseline
|
|
DeJong Gierveld Loneliness Scale
Zeitfenster: 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).
|
Change from baseline each week until 8 weeks and at 8 months post-baseline
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Hemoglobin A1C (HgA1C)
Zeitfenster: 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
|
Change from baseline at 8 weeks and at 8 months post-baseline
|
|
Weight
Zeitfenster: Change from baseline at 8 weeks and at 8 months post-baseline
|
Assessing prevalence of obesity/comorbidities from weight through EMR data
|
Change from baseline at 8 weeks and at 8 months post-baseline
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Elizabeth Alvarez, MD, McMaster University
- Hauptermittler: Yaswanta Gummadi, BHSc, McMaster University
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
30. November 2018
Primärer Abschluss (Tatsächlich)
30. Mai 2020
Studienabschluss (Tatsächlich)
30. Dezember 2020
Studienanmeldedaten
Zuerst eingereicht
4. September 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
5. September 2018
Zuerst gepostet (Tatsächlich)
7. September 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. April 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
2. April 2021
Zuletzt verifiziert
1. April 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Group-based Mindfulness
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .