Effectiveness of a return-to-work assist program for patients on sick leave due to major depressive disorder: a multi-institutional randomized controlled trial

Effectiveness of a return-to-work assist program for patients on sick leave due to major depressive disorder: a multi-institutional randomized controlled trial - Effectiveness of a return-to-work assist program for major depressive disorder: a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010073

Enrollment

120

Registered

2013-02-19

Start date

2011-12-01

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

major depressive disorder

Interventions

A group rehabilitation program, including office work, group psychotherapy, psychoeducation, and sports programs conducted by therapists, held 2 to 5 times per week for 6 months. Treatment as usual an

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 20 to 55 years at screening. 2. Subjects with current DSM-IV major depressive disorder. 3. Patients on sick leave due to major depressive disorder. 4. HAMD-17 <= 15 at screening. 5. Duration of sick leave due to depression of 1 months to 2 years, comprising taking sick leave due to depression up to three times.

Exclusion criteria

Exclusion criteria: 1. Bipolar I disorder 2. Alcohol dependency, alcohol abuse 3. Organic brain disorder 4. Schizophrenia 5. Borderline personality disorder

Design outcomes

Primary

Measure	Time frame
1. Social Adaptation Self-evaluation Scale(SASS) 2. Psychiatric Rework Readiness Scale (PRRS) 3. Hamilton Rating Scale for Depression 17 items (HRSD-17) 4. Beck Depression Inventory-Second Edition (BDI-II) 5. Dysfunctional Attitudes Scale (DAS-24) All outcomes are assessed by blinded assessor (clinical psychologist) before intervention and 24 weeks later from beginning of intervention.	—

Secondary

Measure	Time frame
1. Relapse 2. Return to work 3. Cognitive function	—

Countries

Japan

Contacts

Public ContactYoshie Sakai

Atomi University Department of Clinical Psychology

y-sakai@sb3.so-net.ne.jp048-478-3477

Outcome results

None listed

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