Mental Health Wellness 1HPMINCT01740167
Health Promotion on Young Adults With High Risk Disability for Mental Health
A study testing health promotion lifestyle program in people with Mental Health Wellness 1, run by China Medical University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- health promotion lifestyle program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2012to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- had been diagnosed as schizophrenia, bipolar disorders, and major depression.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health Wellness 1
- Being tested
- health promotion lifestyle program
- Keywords
- prodrome, mental illness, health promotion, lifestyle behavior
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health promotion lifestyle programBehavioural
Individual counseling, once a month, total 3 times.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle program | Experimental | health promotion lifestyle program : individual counseling, once a month, total 3 times. Receives: Behavioral: health promotion lifestyle program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese version of Health-Promotion Lifestyle Profile-Short
Measured: 3 months
Secondary outcomes (1)
Chinese version of Schizotypal Personality Questionnaire-Brief
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionOct 2013 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Wei-Fen Ma, PHD, Principal investigator, China Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740167
- Sponsor's protocol ID
- NSC101-2511-S-039-003
- Other IDs
- DMR101-IRB2-222
- Acronym
- HPMI
- Status last verified
- Nov 2012
- First submitted
- 28 Nov 2012
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Promotion on Young Adults With High Risk Disability for Mental Health: Development and Evaluation of the Screen Prevention Model
- ClinicalTrials.gov ID
- NCT01740167
- Acronym / sponsor ID
- HPMI / NSC101-2511-S-039-003
- Conditions
- Mental Health Wellness 1
- Keywords
- prodrome, mental illness, health promotion, lifestyle behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Nov 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle program | Experimental | Behavioral: health promotion lifestyle programhealth promotion lifestyle program : individual counseling, once a month, total 3 times. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- had been diagnosed as schizophrenia, bipolar disorders, and major depression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| health promotion lifestyle programIndividual counseling, once a month, total 3 times. | Behavioural | Lifestyle program |
Primary outcome
Chinese version of Health-Promotion Lifestyle Profile-Short
Time frame: 3 months
1 secondary outcome
Chinese version of Schizotypal Personality Questionnaire-Brief
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Fen Ma, PHD principal investigator
China Medical University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health promotion lifestyle program in people with Mental Health Wellness 1, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese version of Health-Promotion Lifestyle Profile-Short (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2012.