A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youths With Psychosis (M3)
Primary Purpose
Schizophrenia, Psychotic Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
M3 Program
Control
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
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.
Sites / Locations
- Oregon Health and Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
M3 Program
Control
Arm 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.
Non-randomized control group. Outcomes will be compared at same time points (baseline, 6 weeks, 12 weeks).
Outcomes
Primary Outcome Measures
Feasibility assessed by 6-week program completion by 50% of participants attending at least 60% of the program
Secondary Outcome Measures
Body Mass Index
body mass index
Waist Circumference
waist circumference measured in cm
Lipid Panel
total cholesterol, triglycerides, HDL, LDL
Quick Scale for the Assessment of Negative Symptoms and Positive Symptoms
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.
Connor-Davidson Resilience Scale
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.
Quality of LIfe - SF12
: 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.
Full Information
NCT ID
NCT02398292
First Posted
March 20, 2015
Last Updated
May 23, 2019
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT02398292
Brief Title
A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youths With Psychosis
Acronym
M3
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
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Psychotic Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
M3 Program
Arm Type
Other
Arm 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.
Arm Title
Control
Arm Type
Other
Arm Description
Non-randomized control group. Outcomes will be compared at same time points (baseline, 6 weeks, 12 weeks).
Intervention Type
Other
Intervention Name(s)
M3 Program
Other Intervention Name(s)
Meals, Mindfulness and Moving Foward Program
Intervention Description
Participants and their study partners will learn about food, movement, and mindfulness through hands-on curriculum.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Participants will not participate in M3 program but will have same outcomes measured at same time points (baseline, 6 weeks, 12 weeks).
Primary Outcome Measure Information:
Title
Feasibility assessed by 6-week program completion by 50% of participants attending at least 60% of the program
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Body Mass Index
Description
body mass index
Time Frame
6 and12 weeks
Title
Waist Circumference
Description
waist circumference measured in cm
Time Frame
6 and12 weeks
Title
Lipid Panel
Description
total cholesterol, triglycerides, HDL, LDL
Time Frame
6 and12 weeks
Title
Quick Scale for the Assessment of Negative Symptoms and Positive Symptoms
Description
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.
Time Frame
6 and12 weeks
Title
Connor-Davidson Resilience Scale
Description
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.
Time Frame
6 and12 weeks
Title
Quality of LIfe - SF12
Description
: 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.
Time Frame
6 and12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynne Shinto, ND, MPH
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Craigan Usher, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youths With Psychosis
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