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Evaluating a Primary-Care Group-based Mindfulness Program

2. april 2021 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Ontario
      • Ajax, Ontario, Canada, L1S 2H6
        • Ajax Harwood Clinic

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Generalized Anxiety Disorder - 7 (GAD-7)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient Heath Questionnaire 9 (PHQ-9) for depression
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Hemoglobin A1C (HgA1C)
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

McMaster University

Etterforskere

  • Hovedetterforsker: Elizabeth Alvarez, MD, McMaster University
  • Hovedetterforsker: Yaswanta Gummadi, BHSc, McMaster University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. november 2018

Primær fullføring (Faktiske)

30. mai 2020

Studiet fullført (Faktiske)

30. desember 2020

Datoer for studieregistrering

Først innsendt

4. september 2018

Først innsendt som oppfylte QC-kriteriene

5. september 2018

Først lagt ut (Faktiske)

7. september 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. april 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. april 2021

Sist bekreftet

1. april 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Group-based Mindfulness

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Nei

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