Ezt az oldalt automatikusan lefordították, és a fordítás pontossága nem garantált. Kérjük, olvassa el a angol verzió forrásszöveghez.

From Prevention to Community Integration: IPCST for Severe Mental Illness in Chinese Communities (Hong Kong and Beijing)

2018. június 20. frissítette: TSANG Hector Wing-Hong, The Hong Kong Polytechnic University

From Prevention to Community Integration: Service Models, Intervention Strategies, and Outcome Evaluation for Recovery From Severe Mental Illness in Chinese Communities (Hong Kong and Beijing)

This research project aims at early detection, early intervention, and recovery of individuals with psychosis and prevention of their family members who are at high risk of having developmental problems and developing psychosis episode in later stages of their life.

It consists of two major parts with the following study designs & aims:

Part I : Developing a comprehensive and integrative psychosocial and community skills training programme (IPCST) and conducing a pilot randomised controlled trial to compare the study outcomes between the two settings in Hong Kong and Beijing.

  1. To develop IPCST as an innovative intervention model targeting individuals with first or recent onset of psychosis to reduce their stay in mental hospital and bridges them to independent living in the community with optimal social and professional support;
  2. To evaluate IPCST in terms of the clinical, vocational, and psychosocial outcomes of participants using a randomized controlled trial design and compare these outcomes between Hong Kong and Beijing;
  3. To examine the cost-effectiveness of IPCST in the two cities; and
  4. To train professionals and research personnel in Hong Kong and mainland for implementation

Part II: Exploring the health needs of younger family members of individuals with early psychosis and the strategies in preventing this clinical high risk group from developing psychotic episode and developmental problems in later stages of their lives.

  1. To identify the potential developmental problems or sufferings of theses younger family members living with patients with mental illness;
  2. To provide baseline assessment of their psychosocial stress, mental health, and quality of life;
  3. To identify interventions that may prevent them from developing psychosis and other developmental problems and improve their mental health.

A tanulmány áttekintése

Állapot

Ismeretlen

Körülmények

Részletes leírás

This research is to develop and test on a pilot basis the clinical efficacy of the IPCST on the clinical and recovery outcomes of outpatients with first and recent-onset psychosis in one-year follow-up period in one regional outpatient care service of both Hong Kong and Beijing, China. All outcomes will be assessed by a trained Research Assistant who is blind to group assignment in each city separately. In Hong Kong, the study venue will be one Early Assessment Service for Young People with Early Psychosis (EASY) in Kwai Chung Hospital under the Kowloon West Hospital Cluster, Hospital Authority Hong Kong. In Beijing, the study venues consist of the Sixth Hospital of Peking University, the Chaoyang Third Hospital, and the Haidian Mental Health Hospital.

In both sites, the study venues are serving for first or recent-onset psychosis residing in the community.

Similar to previous psychosocial interventional studies, the primary outcomes of this study are patients' mental status and level of functioning. Secondary outcomes include the rate and length of psychiatric hospitalizations, vocational status, social skills, family functioning, and quality of life.

A total of 100 participants would be recruited for this project, 50 to be recruited from Hong Kong Kwai Chung; 50 to be recruited from mainland China sites.

Part I: Participants of this part will be randomly allocated to experimental or control group.

Experimental group participants will receive a 12-week, 48-hours of IPCST programme which includes both individual and group training on psychoeducation, motivational interviewing skills, neurocognitive and social cognition, and augmented supported employment with social skills.

Control group participants will receive the usual psychiatric treatment they have been receiving from the hospital.

All participants will receive assessment on their primary (symptom severity and functioning) and secondary (re-hospitalisation rates, family functioning, social skills, and employment status and satisfaction, and quality of life) outcomes at baseline and immediately (Post-test 1), 6 months (Post-test 2), and 12 months (Post-test 3) after completion of the interventions by a research assistant. Each assessment episode lasts about 1.5 hours.

Part II: Participants of this part will undergo a 30 minutes to 1 hour individual interview conducted by a research assistant that covers semi-structured open-ended questions and basic assessment of psychosocial stress, health and mental health status, and quality of life using quantitative measures.

Tanulmány típusa

Beavatkozó

Beiratkozás (Várható)

100

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év (Felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

Inclusion Criteria:

  • Hong Kong/ China residents
  • Age between 18-55 years;
  • Primary diagnosis of psychosis (not more than 12 months of clinical diagnosis) by psychiatrist and confirmed with the SCID-I for DSM-IV TR Axis I Disorders (Biometrics Research, 2002);
  • Primary six or above education;
  • Mentally competent to follow the instructions and training and give informed written consent, as suggested by the attending psychiatrist;
  • Able to communicate in Chinese;
  • Intend to seek employment.

Exclusion Criteria:

  • Co-morbidity of learning disability, neurological disorder (e.g., epilepsy) and organic brain disease, or clinically significant medical diseases;
  • Recently participated or are participating in other structured psychosocial intervention, and/or
  • Visual, language or communication difficulty.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Egyetlen

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: IPCST
Intervention = Patients that participate in IPCST programme

Integrative Psychosocial & Community Skills Training (IPCST) programme

The IPCST programme includes:

  1. psychoeducation, internalized stigma reduction, & strength and coping enhancement
  2. motivational interviewing skills
  3. Neurocognitive and social cognitive training (Au, Tsang, So, Bell, Cheung, et al., 2015)
  4. augmented supported employment with social skills training (Tsang, Fung, Li, Leung & Cheung, 2010) and
  5. family and patient involvement in care
Aktív összehasonlító: E.A.S.Y
Treatment as usual = Patients of E.A.S.Y Programme in HK Kwai Chung Hospital

The E.A.S.Y. (Early Assessment Service for Young People with Early Psychosis) Programme is a service programme for people suffering from early psychosis.

The E.A.S.Y programme includes:

  1. Extensive public education
  2. Early referral and assessment
  3. Ongoing treatment services

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change of Positive and Negative Syndrome Scale (PANSS) score
Időkeret: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month

The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia.

Participants will be assessed by medical specialist who will complete their PANSS at baseline, immediately following the completion of the 3-month program, and at 6- & 12- months after completion of the program.

The Change of PANSS score over the above time course is the study's primary outcome measure.

Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Change of The Personal and Social Performance Scale (PSP) score
Időkeret: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month

The Personal and Social Performance scale (PSP) is widely used to assess social functioning in patients with schizophrenia.

Participants will be assessed by medical specialist who will complete their PSP score at baseline, immediately following the completion of the 3-month program, and at 6- & 12- months after completion of the program.

The Change of PSP score over the above time course is the study's primary outcome measure.

Baseline, Completion of the 3-month program, and follow up at 6-, 12- month

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change of Employment Outcome Checklist (EOC) score
Időkeret: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month

The Employment Outcome Checklist (EOC) is used to assess participants' employment outcomes such as the number of job interviews attended, the number of jobs obtained, number of hours per week worked, and salary received from each of the jobs that were obtained .

Participants will be assessed by research assistant who will complete their EOC questionnaire at baseline, immediately following the completion of the 3-month program, and at 6- & 12- months after completion of the program.

The Changes in EOC over the above time course is the study's secondary outcome measure.

Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Change of The Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) score
Időkeret: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month

The Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) is a self-report quality of life measure for people with schizophrenia.

Participants complete on their own the SQLS-R4 questionnaire at baseline, immediately following the completion of the 3-month program, and at 6- & 12- months after completion of the program.

The Change of SQLS-R4 score over the above time course is the study's secondary outcome measure.

Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Change of the Vocational Social Skills Assessment Scale (VSSS) score
Időkeret: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month

The Vocational Social Skills Assessment Scale (VSSS) is a self-administered checklist that measures the participants' subjective perception of their competence in handling work-related social situations.

Participants complete on their own the VSSS questionnaire at baseline, immediately following the completion of the 3-month program, and at 6- & 12- months after completion of the program.

The Change of VSSS score over the above time course is the study's secondary outcome measure.

Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Change of Re-hospitalization rate
Időkeret: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Re-Hospitalization rate measured at Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Change of outpatient follow-up rate
Időkeret: Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
The changes in outpatient follow-up rate measured at Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
Baseline, Completion of the 3-month program, and follow up at 6-, 12- month

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Várható)

2018. augusztus 1.

Elsődleges befejezés (Várható)

2019. december 1.

A tanulmány befejezése (Várható)

2019. december 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2017. augusztus 28.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2018. június 20.

Első közzététel (Tényleges)

2018. június 21.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2018. június 21.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2018. június 20.

Utolsó ellenőrzés

2018. június 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • 1-ZVKP

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

Klinikai vizsgálatok a Pszichózis

Klinikai vizsgálatok a IPCST

3
Iratkozz fel