Chronic Depressive DisorderNCT03084744
Schema Therapy for Chronic Depression
A study testing Schema therapy and Active monitoring in people with Chronic Depressive Disorder and Dysthymic Disorder, run by Institute for Health Economics and Policy, Japan at 1 site in Japan.
Trial summary
To compare the efficacy of schema therapy versus active monitoring for women with chronic depression receiving psychiatric care. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Chronic Depressive Disorder, Dysthymic Disorder
- What is being tested?
- Schema therapy and Active monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteJapan
- Study dates
- 21 Aug 2017to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Senzoku stress coping support office
Tokyo, Ota-ku, 145-0062
Emi Ito, PhD
+81-3-5499-4970, emiito@stress-coping.com
About this study
Official title: Senzoku Intervention of Schema Therapy for Aid and Recovery From Chronic Depression (SISTAR*CD)
To compare the efficacy of schema therapy versus active monitoring for women with chronic depression receiving psychiatric care.
Read the 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%.
- Conditions
- Chronic Depressive Disorder, Dysthymic Disorder
- Being tested
- Schema therapy, Active monitoring
- Medical subject headings
- Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schema therapyBehavioural
Schema therapy for chronic depression, a face-to-face psychological intervention by clinical psychologists.
Active monitoringBehavioural
Active tele-monitoring by clinical psychologists.
| Study group | Role | What they receive |
|---|---|---|
| Schema therapy | Experimental | 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). Receives: Behavioral: Schema therapy |
| Active monitoring | Placebo comparator | Active monitoring by telephone will be implemented by clinical psychologists. The treatment period will be 2 years with monthly 10-minute sessions (up to 24 sessions). Receives: Behavioral: Active monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response (% change from baseline to at 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.
Measured: Baseline, 104 weeks
Secondary outcomes (6)
Remission
Remission was defined as the 17-item GRID-HAMD score of 7 or less at 104 weeks.
Measured: 104 weeks
Change in observer-rated depression severity (17-item HAMD)
Change in observer-rated depression severity was defined as the change score of the 17-item GRID-HAMD from baseline through 104 weeks.
Measured: Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks
Change in observer-rated depression severity (24-item HAMD)
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.
Measured: Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks
Change in self-rated depression severity
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.
Measured: Baseline, 52 weeks, 104 weeks
Change in self-rated quality of life
Change in self-rated quality of life was defined as the change score of the EQ-5D-5L.
Measured: Baseline, 52 weeks, 104 weeks
Medical costs
The cumulative medical costs during 104 weeks for the utilization of medical services will be assessed at each session.
Measured: baseline through 104 weeks (assessed at each session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start21 Aug 2017
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Health Economics and Policy, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Senzoku Stress Coping Support Office
- Responsible party
- Principal investigator, Yasuyuki Okumura, Institute for Health Economics and Policy, Japan
- Investigators
- Yasuyuki Okumura, PhD, Principal investigator, Institute for Health Economics and PolicyEmi Ito, PhD, Principal investigator, Senzoku Stress Coping Support Office
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084744
- Sponsor's protocol ID
- 16207
- Status last verified
- Mar 2018
- First submitted
- 2 Mar 2017
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available to other researchers within 3 years after the publication of the primary paper.
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Senzoku Intervention of Schema Therapy for Aid and Recovery From Chronic Depression (SISTAR*CD)
- ClinicalTrials.gov ID
- NCT03084744
- Acronym / sponsor ID
- 16207
- Conditions
- Chronic Depressive Disorder, Dysthymic Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Institute for Health Economics and Policy, JapanUniversity, hospital or other
- Collaborators
- Senzoku Stress Coping Support Office
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Schema therapy | Experimental | Behavioral: Schema therapySchema 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 | Placebo comparator | Behavioral: Active monitoringActive monitoring by telephone will be implemented by clinical psychologists. The treatment period will be 2 years with monthly 10-minute sessions (up to 24 sessions). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Psychiatric hospitalization within 30 days prior to the enrollment
- Ineligible to receive the protocol treatment during 2 years
- Schizophrenia
- Bipolar disorders
- Intellectual disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Schema therapySchema therapy for chronic depression, a face-to-face psychological intervention by clinical psychologists. | Behavioural | Schema therapy |
| Active monitoringActive tele-monitoring by clinical psychologists. | Behavioural | Active monitoring |
Primary outcome
Treatment response (% change from baseline to at 104 weeks)
Time frame: 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.
6 secondary outcomes
Remission
Time frame: 104 weeks
Change in observer-rated depression severity (17-item HAMD)
Time frame: Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks
Change in observer-rated depression severity (24-item HAMD)
Time frame: Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks
Change in self-rated depression severity
Time frame: Baseline, 52 weeks, 104 weeks
Change in self-rated quality of life
Time frame: Baseline, 52 weeks, 104 weeks
Medical costs
Time frame: baseline through 104 weeks (assessed at each session)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
- Individual participant dataSharing planned: Yes. IPD will be available to other researchers within 3 years after the publication of the primary paper.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasuyuki Okumura, PhD principal investigator
Institute for Health Economics and Policy
Emi Ito, PhD principal investigator
Senzoku Stress Coping Support Office
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schema therapy and Active monitoring in people with Chronic Depressive Disorder and Dysthymic Disorder, run by Institute for Health Economics and Policy, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasuyuki Okumura, PhD (+81-3-3506-8529, yokumura@blue.zero.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response (% change from baseline to at 104 weeks) (time frame: Baseline, 104 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2018.