A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youths With Psychosis (M3)
23. maj 2019 opdateret af: Lynne Shinto, Oregon Health and Science University
Meals, Mindfulness & Moving Forward: A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youth Suffering From Psychosis
The purpose of this study is to determine the feasibility (≥ 50% completion rate) of a 6-week nutrition, movement, and mindfulness program for youth with recent diagnosis of psychosis.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The purpose of this study is to determine the feasibility of a 6-week nutrition, movement, and mindfulness program (M³ Program) for youth with a recent diagnosis of psychosis.
Program effects on metabolic and mental health outcomes compared to wait-list control will also be assessed.
Participants will be 15-25 years of age, and have a recent diagnosis of psychosis.
Twenty participants and their study partners (20 study partners) will be equally divided into two cohorts.
Participants will sign up for one of the two series on a rolling enrollment basis until both of the program date frames are filled.
Participants that signed up for the second series will serve as a wait-list control; outcomes from the participants in the first series will be compared to this group.
M³ will be a combination of didactic and experiential training.
The course will meet once-a-week for six weeks.
Participants will learn how to prepare healthy snacks and meals, make healthy choices when eating out, and interpret food packaging and labels.
They will also learn about different forms of mindfulness exercises and movement, such as yoga, martial arts, and a Japanese style of drumming.
Feasibility will be assessed throughout the program.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
33
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Oregon
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Portland, Oregon, Forenede Stater, 97239
- Oregon Health and Science University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
15 år til 25 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- First diagnosis of psychosis occurs within 3 years of enrollment into the study or are a graduate of the Early Assessment and Support Alliance Program (EASA).
- Established mental health provider and primary care physician.
- Age 15 to 25 years (inclusive)
- Able to enroll with a study partner (study partner can be a healthy volunteer)
- Able to read and write in English
Exclusion Criteria:
- Active suicidal or homicidal thoughts
- Mental status exam which suggests high risk for disruptiveness to group process or danger to self and others.
- If a graduate of EASA, the participant must have a primary care or mental health provider.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: M3 Program
Non-randomized experimental group.
The program is a six-week multi-modal intervention, including nutrition education and cooking classes, physical activity, and mindfulness.
Outcomes will be compared to a non-randomized control group.
|
Participants and their study partners will learn about food, movement, and mindfulness through hands-on curriculum.
Andre navne:
|
|
Andet: Control
Non-randomized control group.
Outcomes will be compared at same time points (baseline, 6 weeks, 12 weeks).
|
Participants will not participate in M3 program but will have same outcomes measured at same time points (baseline, 6 weeks, 12 weeks).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Feasibility assessed by 6-week program completion by 50% of participants attending at least 60% of the program
Tidsramme: 6 weeks
|
6 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Body Mass Index
Tidsramme: 6 and12 weeks
|
body mass index
|
6 and12 weeks
|
|
Waist Circumference
Tidsramme: 6 and12 weeks
|
waist circumference measured in cm
|
6 and12 weeks
|
|
Lipid Panel
Tidsramme: 6 and12 weeks
|
total cholesterol, triglycerides, HDL, LDL
|
6 and12 weeks
|
|
Quick Scale for the Assessment of Negative Symptoms and Positive Symptoms
Tidsramme: 6 and12 weeks
|
A rating scale to measure positive symptoms of schizophrenia.
The QSANS-QSAPS assessment is administered by a trained health professional and takes 30 to 45 minutes to complete.
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6 and12 weeks
|
|
Connor-Davidson Resilience Scale
Tidsramme: 6 and12 weeks
|
A measurement of 'hardiness', or one's ability to successfully cope with stress.
The scale draws on a number of resilient characteristics, including patience, tolerance to negative affect, sense of humor, commitment, recognition of limits to control, engaging the support of others, and adaptability.
The CD-RISC contains 25 items and asks subjects to rate how they felt over the past month on a Likert-type scale.
Total score range is 0 - 100, with higher scores indicating higher levels of resiliency.
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6 and12 weeks
|
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Quality of LIfe - SF12
Tidsramme: 6 and12 weeks
|
: The SF-12 is a 12-item validated shortened version of the SF-36 and was designed to provide a health related quality of life measure that was quick and easy to administer in large population studies.
The SF-12 contains a subset of the 12 items from the SF-36 and information from this subset of questions is used to construct a physical and mental component summary score.
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6 and12 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Craigan Usher, MD, Oregon Health and Science University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2015
Primær færdiggørelse (Faktiske)
1. juli 2016
Studieafslutning (Faktiske)
1. juli 2016
Datoer for studieregistrering
Først indsendt
20. marts 2015
Først indsendt, der opfyldte QC-kriterier
24. marts 2015
Først opslået (Skøn)
25. marts 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. maj 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. maj 2019
Sidst verificeret
1. maj 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 10376
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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