Schizophrenia Clinical Trial
— M3Official title:
Meals, Mindfulness & Moving Forward: A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youth Suffering From Psychosis
NCT number | NCT02398292 |
Other study ID # | 10376 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2015 |
Est. completion date | July 2016 |
Verified date | May 2019 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years to 25 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health and Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility assessed by 6-week program completion by 50% of participants attending at least 60% of the program | 6 weeks | ||
Secondary | Body Mass Index | body mass index | 6 and12 weeks | |
Secondary | Waist Circumference | waist circumference measured in cm | 6 and12 weeks | |
Secondary | Lipid Panel | total cholesterol, triglycerides, HDL, LDL | 6 and12 weeks | |
Secondary | 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. | 6 and12 weeks | |
Secondary | 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. | 6 and12 weeks | |
Secondary | 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. | 6 and12 weeks |
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