Clinical trial NCT02398292: A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youths With Psychosis
Official title: Meals, Mindfulness & Moving Forward: A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youth Suffering From Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Psychotic Disorders
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 33
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility assessed by 6-week program completion by 50% of participants attending at least 60% of the program
timeFrame: 6 weeks
Secondary outcomes:
measure: Body Mass Index
timeFrame: 6 and12 weeks
measure: Waist Circumference
timeFrame: 6 and12 weeks
measure: Lipid Panel
timeFrame: 6 and12 weeks
measure: Quick Scale for the Assessment of Negative Symptoms and Positive Symptoms
timeFrame: 6 and12 weeks
measure: Connor-Davidson Resilience Scale
timeFrame: 6 and12 weeks
measure: Quality of LIfe - SF12
timeFrame: 6 and12 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Lynne Shinto, ND, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Craigan Usher, MD
role: PRINCIPAL_INVESTIGATOR
References: