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Acceptability of Self-Led Mindfulness-Based Intervention

29. oktober 2021 oppdatert av: Holly Hazlett-Stevens, University of Nevada, Reno

Mindfulness and Diabetes Distress: Acceptability of Self-Led Mindfulness-Based Intervention

This study had two primary aims. First, the investigators examined the associations between mindfulness and diabetes-related outcomes. It was hypothesized that at baseline, increased mindfulness would be associated with decreased diabetes distress and more optimal glycemic levels and that all three variables would share similar associations with related constructs including greater self-compassion, lower general stress, better psychosocial health, increased diabetes treatment engagement, and greater diabetes-related quality of life. The association between specific aspects of dispositional mindfulness and diabetes distress was also explored. Second, the investigators examined the acceptability, feasibility, and potential utility of self-led MBSR intervention. It was hypothesized that participation in a self-led MBSR intervention would be feasible and acceptable, evidenced by treatment attrition and participant feedback. It was also hypothesized that participants who received the self-led Mindfulness-based stress reduction (MBSR) intervention would experience increased mindfulness and decreased diabetes distress compared to a waitlist control group.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The goal of the present study was to assess the associations of dispositional mindfulness, diabetes distress, and glycemic outcomes for adolescents with type 1 diabetes as well as to use an iterative approach to developing a self-led scalable mindfulness-based intervention. A self-led mindfulness-based intervention may provide a mindfulness practice to help adolescents with type 1 diabetes improve glycemic outcomes through diabetes distress reduction while also being practical within a pediatric endocrinology clinic. A self-led intervention may also reduce the burden associated with mindfulness-based interventions. This is important considering the heightened emotional and time burden adolescents may already experience due to disease management and the intensity of a traditional mindfulness-based intervention.

This study had two primary aims. First, the investigators examined the associations between mindfulness and diabetes-related outcomes. It was hypothesized that at baseline, increased mindfulness would be associated with decreased diabetes distress and more optimal glycemic levels and that all three variables would share similar associations with related constructs including greater self-compassion, lower general stress, better psychosocial health, increased diabetes treatment engagement, and greater diabetes-related quality of life. The association between specific aspects of dispositional mindfulness and diabetes distress was also explored. Second, the investigators examined the acceptability, feasibility, and potential utility of self-led MBSR intervention. It was hypothesized that participation in a self-led MBSR intervention would be feasible and acceptable, evidenced by treatment attrition and participant feedback. It was also hypothesized that participants who received the self-led MBSR intervention would experience increased mindfulness and decreased diabetes distress compared to a waitlist control group.

Studietype

Intervensjonell

Registrering (Faktiske)

29

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Nevada
      • Reno, Nevada, Forente stater, 89557
        • University of Nevada, Reno

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

13 år til 19 år (Barn, Voksen)

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Aged 13-19 years old
  • Type 1 diabetes diagnosis
  • Currently attending school or a recent high school graduate

Exclusion Criteria:

  • Ward of the state
  • Severe psychiatric disturbances (e.g., active psychosis)
  • Severe developmental delay that hindered ability to self-report

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: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention immediately
The intervention was delivered via a teen MBSR workbook and online communication across the 10-week intervention period. Participants were assigned weekly readings and activities from an MBSR workbook for teens. Topics included understanding stress, introduction to mindfulness, mindful eating and other mindfulness-based intervention principles and were recommended to be completed daily. Mindfulness-based exercises were either self-led per instructions provided in the workbook or to be completed using an audio recording directing participants' behaviors during the exercise.
Atferdsmessig: Mindfulness-Based Stress Reduction
Participants engaged in meditation and self-led exercises to help them understand and cope with stress.
Eksperimentell: Intervention in ten weeks following waitlist
This group received the same intervention as the first arm, however, the participants in arm 2 received the intervention after a 10-week waitlist period. The intervention was delivered via a teen MBSR workbook and online communication across the 10-week intervention period. Participants were assigned weekly readings and activities from an MBSR workbook for teens. Topics included understanding stress, introduction to mindfulness, mindful eating and other mindfulness-based intervention principles and were recommended to be completed daily. Mindfulness-based exercises were either self-led per instructions provided in the workbook or to be completed using an audio recording directing participants' behaviors during the exercise.
Atferdsmessig: Mindfulness-Based Stress Reduction
Participants engaged in meditation and self-led exercises to help them understand and cope with stress.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline in Mindfulness as Assessed by Mindful Attention Awareness Scale-Adolescent (MAAS-A)
Tidsramme: 10 weeks intervention, 20 weeks waitlist
Assessed difference in dispositional mindfulness in adolescents from pre-intervention to post-intervention. The Mindful Attention Awareness Scale-Adolescent has a single-factor structure with 14 items rated on a 6-point scale (1 = almost always, 6 = almost never). Higher scores indicate higher trait mindfulness.
10 weeks intervention, 20 weeks waitlist
Change from Baseline in Engagement in Self-Compassionate Behavior as Assessed by Self-Compassion Scale (SCS)
Tidsramme: 10 weeks intervention, 20 weeks waitlist
Participants rated how often they engage in each self-compassionate behavior in specific situations pre- and post-intervention. The Self-Compassion Scale is a 26-item measure rated on a 5-point scale (1 = almost never, 5 = almost always). Higher scores indicate higher self-compassion.
10 weeks intervention, 20 weeks waitlist
Change from Baseline in Diabetes Stress as Assessed by Diabetes Stress Questionnaire (DSQ)
Tidsramme: 10 weeks intervention, 20 weeks waitlist
Assessed different daily, diabetes-specific stressors from pre-intervention to post-intervention. The Diabetes Stress Questionnaire consists of 65 items and includes eight subscales. Participants rate severity of stress across several diabetes-related scenarios on a 4-point scale (0 = not at all, 3 = very much). Higher scores indicate higher diabetes distress.
10 weeks intervention, 20 weeks waitlist
Change from Baseline in Health-Related Quality of Life as Assessed by Pediatric Quality of Life Inventory (PedsQL) 3.2 Diabetes Module
Tidsramme: 10 weeks intervention, 20 weeks waitlist
Assessed diabetes-specific, health-related quality of life in children, adolescents, and young adults from pre-intervention to post-intervention. The Pediatric Quality of Life Inventory 3.2 Diabetes Module consists of 33 items rated on a 5-point scale (0 = never, 4 = almost always). Higher scores indicate greater quality of life.
10 weeks intervention, 20 weeks waitlist
Change from Baseline in Perceived Stress as Assessed by Perceived Stress Scale-10 Item Version (PSS-10)
Tidsramme: 10 weeks intervention, 20 weeks waitlist
Assessed the severity of broad, stressful situations in adolescents from pre-intervention to post-intervention. Participants rank how often each statement applies to their feelings of stress on a 5-point scale (0 = never, 4 = very often). Negative items are reversed and the sum of all 10 items is calculated. Higher scores indicate higher perceived stress.
10 weeks intervention, 20 weeks waitlist
Change from Baseline in Psychosocial Impairment as Assessed by Pediatric Symptoms Checklist-17 (PSC-17)
Tidsramme: 10 weeks intervention, 20 weeks waitlist
Assessed psychosocial functioning from pre-intervention to post-intervention. Participants rate how frequently each symptom occurs on a 3-point scale (0 = never, 2 = often). Total scores range from 0-34 with higher scores indicating greater risk of psychosocial impairment.
10 weeks intervention, 20 weeks waitlist
Change from Baseline in Diabetes Treatment Engagement as Assessed by Self Care Inventory (SCI)
Tidsramme: 10 weeks intervention, 20 weeks waitlist
Assessed to what degree individuals follow health care provider guidelines for diabetes-management behaviors from pre-intervention to post-intervention. The investigators removed the item "how frequently do you come in for appointments" from the study as the measure was not used within a physician/ appointment context. After removing the item, the Self Care Inventory consisted of 22 items and is rated on a 5-point scale (1 = never, 5 = always). Higher scores indicate higher diabetes treatment engagement.
10 weeks intervention, 20 weeks waitlist
Change from Baseline in Glycosylated Hemoglobin Percentage
Tidsramme: 10 weeks intervention, 20 weeks waitlist
Assessed the difference in glycosylated hemoglobin percentage from pre-intervention to post-intervention.
10 weeks intervention, 20 weeks waitlist
Engagement with the Scaled Mindfulness-Based Intervention as Assessed by Number of Weekly Surveys Completed.
Tidsramme: 20 weeks
Assessed the number of weekly surveys each participant completed during the intervention period. Participants were asked to complete at least 6 out of the 10 weekly surveys during the intervention period to be considered highly engaged.
20 weeks
Feasibility of the Scaled Mindfulness-Based Intervention as Assessed by Participant Feedback
Tidsramme: 20 weeks
Assessed the acceptability and feasibility of a mindfulness-based intervention for teens with type 1 diabetes by examining participant feedback on reasons for attrition and low engagement. Weekly feedback surveys asked about barriers to engaging in the weekly material.
20 weeks

Samarbeidspartnere og etterforskere

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Sponsor

University of Nevada, Reno

Samarbeidspartnere

AlterMed Research foundation

Etterforskere

  • Hovedetterforsker: Holly Hazlett-Stevens, Ph.D., University of Nevada, Reno
  • Hovedetterforsker: Amy Hughes Lansing, Ph.D., University of Nevada, Reno

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

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)

14. juli 2019

Primær fullføring (Faktiske)

17. april 2020

Studiet fullført (Faktiske)

17. juli 2020

Datoer for studieregistrering

Først innsendt

11. oktober 2021

Først innsendt som oppfylte QC-kriteriene

29. oktober 2021

Først lagt ut (Faktiske)

10. november 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. oktober 2021

Sist bekreftet

1. oktober 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1221205

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Overall analyses and scales can be shared as described in participant consent, however, individual participant data will not be shared.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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Kliniske studier på Diabetes mellitus, type 1

Kliniske studier på Mindfulness-Based Stress Reduction

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