Mindfulness based cognitive therapy versus group cognitive behavioral therapy in adults with Major Depression: a Randomized non-inferiority Clinical Trial

Mindfulness based cognitive therapy versus group cognitive behavioral therapy in adults with Major Depression: a Randomized non-inferiority Clinical Trial - CERTAIN study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000050345

Enrollment

100

Registered

2023-02-15

Start date

2023-03-01

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

Mindfulness based cognitive therapy Cognitive behavioral group therapy

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Group differences in total GRID-Hamilton Depression Rating Scale (HAMD17) scores between MBCT and CBGT groups at post-intervention.	—

Secondary

Measure	Time frame
-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)	—

Measure

Time frame

-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)

—

Countries

Japan

Contacts

Public ContactNariko Katayama

Keio University School of Medicine Nauro-psychiatry department

narikoktym@keio.jp03-5363-3971

Outcome results

None listed

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