A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youths With Psychosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia Psychotic Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

M3 Program

Intervention Type OTHER

Participants and their study partners will learn about food, movement, and mindfulness through hands-on curriculum.

Control

Non-randomized control group. Outcomes will be compared at same time points (baseline, 6 weeks, 12 weeks).

Group Type OTHER

Control

Intervention Type OTHER

Participants will not participate in M3 program but will have same outcomes measured at same time points (baseline, 6 weeks, 12 weeks).

Interventions

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M3 Program

Participants and their study partners will learn about food, movement, and mindfulness through hands-on curriculum.

Intervention Type OTHER

Control

Participants will not participate in M3 program but will have same outcomes measured at same time points (baseline, 6 weeks, 12 weeks).

Intervention Type OTHER

Other Intervention Names

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Meals, Mindfulness and Moving Foward Program

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes