Clinical trial NCT00919620: Stage-specific Case Management for Early Psychosis
Official title: Outcome of Stage-specific Early Intervention for Psychosis in Hong Kong: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Keywords: Psychotic disorders
Psychoses
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
name: Kwai Chung Hospital
name: Kowloon Hospital, Hong Kong
name: Castle Peak Hospital
name: Shatin Hospital
name: Tai Po Hospital
name: North District Hospital, Hong Kong
name: United Christian Hospital
name: Queen Elizabeth Hospital, Hong Kong
First posted: 2009-06-12
Enrollment: 360
Sex: ALL
Minimum age (years): 26
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One of the commonly adopted strategies in improving outcome in psychotic disorders is by focused, specific and intensive intervention in the initial few years of the disorder. However the effects of intervention and the optimal duration of intervention have seldom been examined in randomized studies. This study uses a randomized controlled study design to investigate the effectiveness of stage-specific case-management in improving outcome of first episode psychotic disorders. It also addresses whether two years of case-management is less effective than four years of case-management over a four year period. A total of 360 subjects, who aged 25 above, and diagnosed with first episode psychotic disorders, will be and randomized into 3 groups: (1) standard care alone without case management, (2) two-year case management, (3) four-year case management. All groups will receive usual standard care treatment. This four-year follow-up study will assess symptoms, functioning, quality of life as well as health economics data.

Detailed description: Psychotic disorder is a debilitating illness which imposes substantial impact to the patients, their families, and the society. The provision of early intervention provides a window of opportunity to minimize the social and economic burden incurred by the illness.

Many previous studies of effectiveness of early intervention used the historical control approach and are subjected to cohort effects. For example, change of medication pattern over time could potentially lead to differences in outcome. In addition, few studies provide longer-term outcome data of treatment program beyond two years. The optimal length of intervention has not been determined, and many programmes used 12-24 month intervention mainly based on resources available. It is also important to ask whether favorable effects of early intervention could be sustained over time. Further analyses will be done to assess whether EI effects are more pronounced in particular subgroups including DUP, age, sex and diagnosis.

The proposed study aims to address these issues by using a randomized controlled design to investigate the longer-term (4 year) outcome of patients with first episode psychosis. The study randomizes 360 patients with first episode psychotic disorders into 3 groups: (1) standard care (outpatient based care with inpatient and community care as required); (2) standard care with 2 years of add-on stage specific case-management (individualized care delivered by designated case managers according to specific protocol); and (3) standard care with 4 years of add-on stage specific case management.

The study hypothesis are: (1) both 2 years and 4 years of case management produce better outcomes than standard care alone; (2) 4 years of case management produces better outcome than 2 years of case management.

Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia, schizoaffective disorder, schizophreniform psychosis, brief psychosis, psychosis nos or delusional disorder
* Cantonese-speaking Chinese
* Ability to understand the nature of the study and sign informed consent
* Capacity to participate in cognitive testing

Exclusion Criteria:

* Organic Brain disorder
* Known history of intellectual disability

Primary outcomes:
measure: Functioning (social and occupational)
timeFrame: baseline, 6-month, 12-month, 24-month, 36-month, 48-month
Secondary outcomes:
measure: Psychotic symptoms
timeFrame: baseline, 6-month, 12-month, 24-month, 36-month, 48-month
measure: Psychotic symptoms
timeFrame: baseline, 6-month, 12-month, 24-month, 36-month, 48-month
measure: Psychotic symptoms
timeFrame: baseline, 6-month, 12-month, 24-month, 36-month, 48-month
measure: Depressive symptoms
timeFrame: baseline, 12-month, 24-month, 36-month, 48-month
measure: Neurocognitive functioning
timeFrame: baseline, 12-month, 24-month, 36-month, 48-month
measure: Health economics
timeFrame: baseline, 6-month, 12-month, 24-month, 36-month, 48-month
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Eric YH Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hui CLM, Wong AKH, Ho ECN, Lam BST, Hui PWM, Tao TJ, Chang WC, Chan SKW, Lee EHM, Suen YN, Lam MML, Chiu CPY, Li FWS, Leung KF, McGhee SM, Law CW, Chung DWS, Yeung WS, Yiu MGC, Pang EPF, Tso S, Lui SSY, Hung SF, Lee WK, Yip KC, Kwan KL, Ng RMK, Sham PC, Honer WG, Chen EYH. Effectiveness and optimal duration of early intervention treatment in adult-onset psychosis: a randomized clinical trial. Psychol Med. 2023 Apr;53(6):2339-2351. doi: 10.1017/S0033291721004189. Epub 2022 Feb 11.
citation: Puntis S, Minichino A, De Crescenzo F, Cipriani A, Lennox B, Harrison R. Specialised early intervention teams for recent-onset psychosis. Cochrane Database Syst Rev. 2020 Nov 2;11(11):CD013288. doi: 10.1002/14651858.CD013288.pub2.