Senzoku Intervention of Schema Therapy for Aid and Recovery from Chronic Depression (SISTAR*CD)

Senzoku Intervention of Schema Therapy for Aid and Recovery from Chronic Depression (SISTAR*CD) - Schema Therapy for Chronic Depression

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026420

Enrollment

Registered

2017-03-25

Start date

2017-08-21

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

Chronic depression

Interventions

Schema therapy in an individual format will be implemented by clinical psychologists. The treatment period will be 2 years with biweekly 50-minute sessions (up to 48 sessions). Active monitoring by te

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: -Persistent depressive disorder including chronic major depressive disorder and dysthymic disorder assessed by the Structured Clinical Interview for DSM -Scores of at least 14 on the GRID-HAMD -Psychiatric treatment duration for depression of at least 3 years

Exclusion criteria

Exclusion criteria: -Psychiatric hospitalization within 30 days prior to the enrollment -Ineligible to receive the protocol treatment during 2 years -Schizophrenia -Bipolar disorders -Intellectual disabilities -Neurocognitive disorders -Substance-related disorders

Design outcomes

Primary

Measure	Time frame
Treatment response was defined as 50% or greater reduction in depressive symptoms (the 17-item GRID-Hamilton Depression Rating Scale; GRID-HAMD) at 104 weeks compared with baseline. The GRID-HAMD will be administered by clinical psychologists who will be blinded to treatment assignments. The 17- and 24-item GRID-HAMD will be assessed at baseline, 26 weeks, 52 weeks, 78 weeks, and 104 weeks.	—

Secondary

Measure	Time frame
Remission was defined as the 17-item GRID-HAMD score of 7 or less at 104 weeks. Change in observer-rated depression severity was defined as the change score of the 17- and 21-item GRID-HAMD from baseline through 104 weeks. Change in self-rated depression severity was defined as the change score of the Beck Depression Scale-II (BDI-II) from baseline through 104 weeks. The BDI-II will be assessed at baseline, 52 weeks, and 104 weeks. Change in self-rated quality of life was defined as the change score of the EQ-5D-5L. The EQ-5D-5L will be assessed at baseline, 52 weeks, and 104 weeks. Utility scores assessed by the EQ-5D-5L, depression severity assessed by the GRID-HAMD and BDI-II, and the utilization of medical services will be used for estimating cost-effectiveness and cost-utility.	—

Measure

Time frame

Remission was defined as the 17-item GRID-HAMD score of 7 or less at 104 weeks. Change in observer-rated depression severity was defined as the change score of the 17- and 21-item GRID-HAMD from baseline through 104 weeks. Change in self-rated depression severity was defined as the change score of the Beck Depression Scale-II (BDI-II) from baseline through 104 weeks. The BDI-II will be assessed at baseline, 52 weeks, and 104 weeks. Change in self-rated quality of life was defined as the change score of the EQ-5D-5L. The EQ-5D-5L will be assessed at baseline, 52 weeks, and 104 weeks. Utility scores assessed by the EQ-5D-5L, depression severity assessed by the GRID-HAMD and BDI-II, and the utilization of medical services will be used for estimating cost-effectiveness and cost-utility.

—

Countries

Japan

Contacts

Public ContactYasuyuki Okumura

Initiative for Clinical Epidemiological Research President

yokumura@blue.zero.jp0428-16-2619

Outcome results

None listed

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