- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02398292
A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youths With Psychosis (M3)
23 maj 2019 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
33
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Oregon
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Portland, Oregon, Förenta staterna, 97239
- Oregon Health and Science University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
15 år till 25 år (Barn, Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Övrig: 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.
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Participants and their study partners will learn about food, movement, and mindfulness through hands-on curriculum.
Andra namn:
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Övrig: Control
Non-randomized control group.
Outcomes will be compared at same time points (baseline, 6 weeks, 12 weeks).
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Feasibility assessed by 6-week program completion by 50% of participants attending at least 60% of the program
Tidsram: 6 weeks
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6 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Body Mass Index
Tidsram: 6 and12 weeks
|
body mass index
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6 and12 weeks
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Waist Circumference
Tidsram: 6 and12 weeks
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waist circumference measured in cm
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6 and12 weeks
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Lipid Panel
Tidsram: 6 and12 weeks
|
total cholesterol, triglycerides, HDL, LDL
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6 and12 weeks
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Quick Scale for the Assessment of Negative Symptoms and Positive Symptoms
Tidsram: 6 and12 weeks
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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
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Connor-Davidson Resilience Scale
Tidsram: 6 and12 weeks
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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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Craigan Usher, MD, Oregon Health and Science University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2015
Primärt slutförande (Faktisk)
1 juli 2016
Avslutad studie (Faktisk)
1 juli 2016
Studieregistreringsdatum
Först inskickad
20 mars 2015
Först inskickad som uppfyllde QC-kriterierna
24 mars 2015
Första postat (Uppskatta)
25 mars 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 maj 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 maj 2019
Senast verifierad
1 maj 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 10376
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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