Skip to content

A multicenter randomized control trial in Japan of comprehensive early intervention in first-episode psychosis.

A multicenter randomized control trial in Japan of comprehensive early intervention in first-episode psychosis. - Japanese Comprehensive Approach to Psychosis (J-CAP) study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005092
Enrollment
150
Registered
2011-02-15
Start date
2011-03-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients diagnosed as having ICD-10 (International Classification of Disease, 10th revision) F2 or F3 with psychotic symptoms

Interventions

Casemanagement (CM) group: Participants will receive standard medical care and additional case management from well-trained case managers about their symptoms and daily activities for 18 months after
recovery and social participation in cooperation with the early intervention team, using combination of cognitive behavioral therapeutic approach, psychoeducational approach, family intervention, disc

Sponsors

Department of Neuropsychiatry, Graduate School of Medicine, the University of Tokyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. within 5 years from onset of psychotic symptoms. 2. first-episode psychosis. 3. live in the catchment area of each site. 4. have presented written informed consent to the ethical committee of each site, according to the Declaration of Helsinki after having been given a complete explanation of this study.

Exclusion criteria

Exclusion criteria: 1. premorbid IQ under 80. 2. unable to have sufficient communication in Japanese. 3. need care for any organic mental disorder. 4. need inpatient care for any physical condition. 5. have a history of dependency on alcohol and/or any other substance of abuse. 6. under physical restraint and/or seclusion. 7. have received electro convulsive therapy and/or transcranial magnetic stimulation therapy within the past month. 8. presently in involuntary hospitalization. 9. have not received the explanation of one's condition or diagnosis from psychiatrists. 10. regarded as inappropriate by the physician in charge for any other reason.

Design outcomes

Primary

MeasureTime frame
Global Assessment of Functioning, Function domain (GAF-F) scores in the first endpoint (18 months after registration)

Secondary

MeasureTime frame
GAF-F, Global Assessment of Functioning, Symptom domain (GAF-S), Positive And Negative Symptom Scales (PANSS), the World Health Organization Quality Of Life 26-item version (WHO-QOL26), care satisfaction, educational and vocational recovery rate, relapse rate, lost to follow-up rate, self-harm and suicidal attempt rate, suicide rate, number of visit to out-patient units, days of stay in hospital, Brief Evaluation of Medication Influences and Beliefs (BEMIB), and direct and indirect costs at each endpoint (18 months, 36 months, and 60 months).

Countries

Japan

Contacts

Public ContactShinsuke Koike

the University of Tokyo Faculty of Arts and Sciences

skoike-tky@umin.ac.jp+81-3-5454-4327

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026