UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050345 |
|---|---|
| Receipt number | R000057333 |
| Scientific Title | Mindfulness based cognitive therapy versus group cognitive behavioral therapy in adults with Major Depression: a Randomized non-inferiority Clinical Trial |
| Date of disclosure of the study information | 2023/02/15 |
| Last modified on | 2023/08/17 18:11:48 |
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Basic information
Public title
Mindfulness based cognitive therapy versus group cognitive behavioral therapy in adults with Major Depression: a Randomized non-inferiority Clinical Trial
Acronym
CERTAIN Study
Scientific Title
Mindfulness based cognitive therapy versus group cognitive behavioral therapy in adults with Major Depression: a Randomized non-inferiority Clinical Trial
Scientific Title:Acronym
CERTAIN study
Region
| Japan |
Condition
Condition
Major Depressive Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary object of this study is to verify the hypothesis that Mindfulness-based Cognitive Therapy (MBCT) is no less effective for adults with major depression than Cognitive Behavioral Group Therapy (CBGT).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Group differences in total GRID-Hamilton Depression Rating Scale (HAMD17) scores between MBCT and CBGT groups at post-intervention.
Key secondary outcomes
-Depression symptoms: GRID-Hamilton Depression Rating Scale, Beck Depression Inventory, Quick Inventory of Depressive Symptomatology
-Remission: defined as HAMD-17=<7, QIDS score<5
-Response: defined as 50% reduction of baseline HAMD-17 total score or QIDS score
-Anxiety symptoms: Generalized Anxiety Disorder -7
-Anger rumination: Anger Rumination Scale
-Automatic thoughts: Automatic Thoughts Questionnaire Revised,
-Decentering: Experiences Questionnaire
-Mindfulness: Five Facet Mindfulness Questionnaire
-Well-being: Satisfaction With Life Scale
-Rumination: Ruminative Response Scale
-resting state functional connectivity (resting-fMRI)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Mindfulness based cognitive therapy
Interventions/Control_2
Cognitive behavioral group therapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects with DSM-IV Major Depressive Disorder based on Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorder (SCID) at screening.
2. Subjects with HAMD-17 score >=8/<=18 at screening.
3. Subjects who give full consent in the participation of the study.
Key exclusion criteria
1. No comorbid alcohol or substance use disorder in 2 years prior to the screening.
2. No history or concurrent manic or psychotic episode.
3. No other primary DSM-IV Axis I Disorders in 6 months prior to the screening.
4. No comorbid of antisocial personality disorder.
5. No serious and imminent suicidal ideation at screening.
6. No prior experience with previous MBCT program (4 or more sessions) or CBGT program (4 or more sessions).
7. Unlikely to attend more than 4 visits during the 8-week trial phase (eg, due to relocation).
8. No intention of engaging in homework
9. No organic brain lesions or major cognitive deficits in a year prior to the screening.
10. No severe or unstable medical illness at screening.
11. Contraindication to MRI (including cardiac pacemaker, claustrophobia)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nariko |
| Middle name | |
| Last name | Katayama |
Organization
Keio University School of Medicine
Division name
Nauro-psychiatry department
Zip code
160-0016
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3971
narikoktym@keio.jp
Public contact
Name of contact person
| 1st name | Nariko |
| Middle name | |
| Last name | Katayama |
Organization
Keio University School of Medicine
Division name
Nauro-psychiatry department
Zip code
160-0016
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3971
Homepage URL
narikoktym@keio.jp
Sponsor or person
Institute
Keio Universiyt of medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3971
narikoktym@keio.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
慶應義塾大学医学部/慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 15 | Day |
Last modified on
| 2023 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057333
