A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youths With Psychosis (M3)

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Psychotic Disorders; Schizophrenia

Treatments: Other: M3 Program; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02398292

10376

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 33 patients

Sex: All

Ages: 15 to 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

M3 Program

Other group

Description:

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.

Treatment:

Other: M3 Program

Control

Other group

Description:

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

Treatment:

Other: Control