Shared Decision Making for Patients With First-admission Schizophrenia

• Sponsor: Yokohama City University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01869660
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

To determine whether shared decision making (SDM) intervention improves patient satisfaction in patients with first-admission schizophrenia compared with usual care.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Behavioral: Shared Decision Making	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Shared Decision Making for Patients With First-admission Schizophrenia: a Randomized Controlled Trial
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Shared Decision Making The present SDM intervention is based on principles derived from previous randomized controlled trials of SDMs. SDM meetings comprise at least 4 weekly 20 minutes sessions. Meetings have at least three professionals: a case manager (psychiatrists or nurses), a primary doctor, and a nurse/social worker. The focus of the meeting is to empower patients to discuss their attitudes and preferences toward treatments.	Behavioral: Shared Decision Making; The focus of the SDM is to empower patients to discuss their attitudes and preferences toward treatments.
No Intervention: Usual Care Patients with no special program about decision making.

Outcome Measures

Primary Outcome Measures

1. Patient satisfaction as measured by the Japanese version of the Client Satisfaction Questionnaire (CSQ-8) [Within 7days before the date of discharge]

Secondary Outcome Measures

1. Attitude toward medication as measured by the Japanese version of the Drug Attitude Inventory (DAI-10) [Within 7days before the date of discharge]

2. Treatment continuation as measured by the rate of outpatient attendance during the 30 days [6 months after discharge]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Admitted to an acute care psychiatric ward.

• Diagnosed with schizophrenia (ICD-10 codes: F20-F29)

• Aged 16 to 65 years old at admission

• No prior experience of psychiatric admission (first-admission)

Exclusion Criteria:

• Diagnosed with moderate to severe mental retardation

• Diagnosed with organic mental disorders (ICD10 codes: F00-F09)

• Having poor Japanese language skill

• Severe conceptual disorganization as measured by brief psychiatric rating scale of 5 or more.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Numazu Chuou Hospital	Numazu	Shizuoka	Japan

Sponsors and Collaborators

• Yokohama City University

Investigators

• Study Chair: Yoshio Hirayasu, PhD, Department of Psychiatry, Yokohama City University School of Medical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yokohama City University
• ClinicalTrials.gov Identifier: NCT01869660
• Other Study ID Numbers: SDMS-S
• First Posted: Jun 5, 2013
• Last Update Posted: Dec 30, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Yokohama City University: First hospitalization
• Additional relevant MeSH terms: Schizophrenia

Study Results

No Results Posted as of Dec 30, 2015