Chronic Depressive Disorder, Dysthymic Disorder
Conditions
Brief summary
To compare the efficacy of schema therapy versus active monitoring for women with chronic depression receiving psychiatric care.
Detailed description
A randomized, assessor-blind, single center, superiority trial will be conducted. Participants will be referred to clinical psychologists in a private counseling office (Senzoku Stress Coping Support Office, in Japan). Eligible participants will be women with chronic depression receiving psychiatric care. Participants will receive schema therapy or active monitoring during 2 years. Primary outcome will be treatment response. A total sample size of 64 (32 in each group) would be required to provide 80% power at a 2-sided significance level of 5% to detect a risk difference of 35% (response rate: 55% for schema therapy vs. 20% for active monitoring), assuming a dropout rate of 10%.
Interventions
BEHAVIORALSchema therapy
Schema therapy for chronic depression, a face-to-face psychological intervention by clinical psychologists.
BEHAVIORALActive monitoring
Active tele-monitoring by clinical psychologists.
Sponsors
Senzoku Stress Coping Support Office
Institute for Health Economics and Policy, Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors of the primary outcome will be blinded to treatment assignments.
Intervention model description
Participants will be randomly allocated into two groups using a web-based central allocation system. This system will confirm allocation concealment and random sequence generation.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
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
* 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 | Description |
|---|---|---|
| Treatment response (% change from baseline to at 104 weeks) | Baseline, 104 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in observer-rated depression severity (17-item HAMD) | Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks | Change in observer-rated depression severity was defined as the change score of the 17-item GRID-HAMD from baseline through 104 weeks. |
| Change in observer-rated depression severity (24-item HAMD) | Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks | Change in observer-rated depression severity was defined as the change score of the 24-item GRID-HAMD from baseline through 104 weeks. The 24-item GRID-HAMD will be administered by clinical psychologists who will be blinded to treatment assignments. |
| Remission | 104 weeks | Remission was defined as the 17-item GRID-HAMD score of 7 or less at 104 weeks. |
| Change in self-rated quality of life | Baseline, 52 weeks, 104 weeks | Change in self-rated quality of life was defined as the change score of the EQ-5D-5L. |
| Medical costs | baseline through 104 weeks (assessed at each session) | The cumulative medical costs during 104 weeks for the utilization of medical services will be assessed at each session. |
| Change in self-rated depression severity | Baseline, 52 weeks, 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. |
Countries
Japan
Contacts
Primary ContactYasuyuki Okumura, PhD
Backup ContactEmi Ito, PhD
Outcome results
None listed