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Health Promotion on Young Adults With High Risk Disability for Mental Health (HPMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01740167
Recruitment Status : Unknown
Verified November 2012 by China Medical University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
China Medical University Hospital

Tracking Information
First Submitted Date  ICMJE November 28, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date December 4, 2012
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
Chinese version of Health-Promotion Lifestyle Profile-Short [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
Chinese version of Schizotypal Personality Questionnaire-Brief [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 30, 2012)
  • Chinese mandarin version of State-Trait Anxiety Inventory from Y [ Time Frame: 3 months ]
  • simple physical assessment [ Time Frame: 3 months ]
  • Personal Inventory [ Time Frame: 3 months ]
  • 3 months physical activity assessment [ Time Frame: 3 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Health Promotion on Young Adults With High Risk Disability for Mental Health
Official Title  ICMJE Health Promotion on Young Adults With High Risk Disability for Mental Health: Development and Evaluation of the Screen Prevention Model
Brief Summary
  1. The positive outcomes reported by participants in experimental group after two weeks of interventions will be significantly better than before interventions.
  2. 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.
  3. 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Mental Health Wellness 1
Intervention  ICMJE Behavioral: health promotion lifestyle program
Individual counseling, once a month, total 3 times.
Study Arms  ICMJE Experimental: Lifestyle program
health promotion lifestyle program : individual counseling, once a month, total 3 times.
Intervention: Behavioral: health promotion lifestyle program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 30, 2012)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2015
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01740167
Other Study ID Numbers  ICMJE NSC101-2511-S-039-003
DMR101-IRB2-222 ( Other Identifier: ChinaMUH )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party China Medical University Hospital
Study Sponsor  ICMJE China Medical University Hospital
Collaborators  ICMJE National Science Council, Taiwan
Investigators  ICMJE
Principal Investigator: Wei-Fen Ma, PHD China Medical University, Taiwan
PRS Account China Medical University Hospital
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP