- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01740167
Health Promotion on Young Adults With High Risk Disability for Mental Health (HPMI)
November 30, 2012 updated by: China Medical University Hospital
Health Promotion on Young Adults With High Risk Disability for Mental Health: Development and Evaluation of the Screen Prevention Model
- The positive outcomes reported by participants in experimental group after two weeks of interventions will be significantly better than before interventions.
- The positive outcomes reported by participants in experimental group will be significantly better than those in control group after two weeks of providing prevention model interventions.
- The positive outcomes reported by participants in experimental group will be significantly better than those in control group after six months of providing prevention model interventions.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Early finding for people with high mental risk plays the important role in mental health promotion.
In literature, before specific psychotic symptoms appear, individuals may experience a period of nonspecific symptoms and growing functional impairment.
Early interventions may alter the natural course of mental diseases and improve treatment outcomes.
So that, the purpose of this study is to develop a screen and prevention mode for identifying young adults with high risk status of mental health disability.
The psychosocial intervention strategies for emotional and cognitive support in prevention model based on health promotion theory will be used for this study.
Participants in this experimental design study will be randomly assigned into experimental and control groups.
Four scales and objective physical assessments are used for evaluating study outcomes.
The pre- and post-test will be held before and one week after prevention interventions.
In addition, follow-ups will be included for understanding long-term outcomes of the effectiveness of the screen prevention model.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taichung, Taiwan, 40402
- China Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 20-65 years, (Chinese version of Schizotypal Personality Questionnaire-Brief > 17 scores, or Chinese Mandarin State Trait Anxiety Inventory Y2 > 60 scores), and agree to participants.
Exclusion Criteria:
- had been diagnosed as schizophrenia, bipolar disorders, and major depression.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lifestyle program
health promotion lifestyle program : individual counseling, once a month, total 3 times.
|
Individual counseling, once a month, total 3 times.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Chinese version of Health-Promotion Lifestyle Profile-Short
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Chinese version of Schizotypal Personality Questionnaire-Brief
Time Frame: 3 months
|
3 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Chinese mandarin version of State-Trait Anxiety Inventory from Y
Time Frame: 3 months
|
3 months
|
|
simple physical assessment
Time Frame: 3 months
|
3 months
|
|
Personal Inventory
Time Frame: 3 months
|
3 months
|
|
3 months physical activity assessment
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Wei-Fen Ma, PHD, China Medical University, Taiwan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Anticipated)
October 1, 2013
Study Completion (Anticipated)
October 1, 2015
Study Registration Dates
First Submitted
November 28, 2012
First Submitted That Met QC Criteria
November 30, 2012
First Posted (Estimate)
December 4, 2012
Study Record Updates
Last Update Posted (Estimate)
December 4, 2012
Last Update Submitted That Met QC Criteria
November 30, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- NSC101-2511-S-039-003
- DMR101-IRB2-222 (Other Identifier: ChinaMUH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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