Health Promotion on Young Adults With High Risk Disability for Mental Health

Mental Health Wellness 1 Clinical Trial

— HPMI  

Official title:

Health Promotion on Young Adults With High Risk Disability for Mental Health: Development and Evaluation of the Screen Prevention Model

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01740167
• Other study ID #: NSC101-2511-S-039-003
• Secondary ID: DMR101-IRB2-222
• Status: Active, not recruiting
• Phase: N/A
• First received: November 28, 2012
• Last updated: November 30, 2012
• Start date: November 2012
• Est. completion date: October 2015

Study information

• Verified date: November 2012
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: October 2015
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mental Health Wellness 1

Intervention

Behavioral:
• health promotion lifestyle program
Individual counseling, once a month, total 3 times.

Locations

Country	Name	City	State
Taiwan	China Medical University	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Chinese mandarin version of State-Trait Anxiety Inventory from Y		3 months	No
Other	simple physical assessment		3 months	No
Other	Personal Inventory		3 months	No
Other	3 months physical activity assessment		3 months	No
Primary	Chinese version of Health-Promotion Lifestyle Profile-Short		3 months	No
Secondary	Chinese version of Schizotypal Personality Questionnaire-Brief		3 months	No