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The Study of Mindfulness-based Cognitive Therapy and Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Mindfulness-based Cognitive Therapy

Medication

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Mindfulness-Based Cognitive Therapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria for patient cases:

Male or female, age between 18-55 years.
Junior/middle school education or above.
Meet the DSM- IV diagnosis of MDD by the evaluation of Chinese version of M.I.N.I. and the clinical diagnosis of one associate chief and above psychiatrist.
HAMD24 score ≥ 8.
Have not yet accepted psychiatric medication, or had received irregular medication treatment and had discontinued it for 8 weeks.
Have enough visual and acoustic ability to complete the inspection required for the study.
Each patient should be willing to participate in this study, he/she and his/her guardian must sign the informed consent form after understanding the nature of this study.

Inclusion criteria for normal controls:

Healthy population matched patient cases in age, sex and education; Male or female; age between 18-55 years; Junior/middle school education or above.
Excluded the possibility of mental disorders by the evaluation of Chinese version of M.I.N.I. and the psychiatric interview of one associate chief and above psychiatrist.
HAMD24 score < 8; HAMA score < 7.
No psychotropic drug history.
No history of two lines of three generations of mental disorders.
Have enough visual and acoustic ability to complete the inspection required for the study.
Each patient should be willing to participate in this study, he/she and his/her guardian must sign the informed consent form after understanding the nature of this study.

Exclusion criteria for patient cases:

Meet DSM-IV Axis I disorder diagnostic criteria for other psychiatric disorders.
Have severe depression symptoms (HAMD24 score > 35), psychotic symptoms, negative self-concept or a risk of suicide.
Persons with severe physical disease or central nervous system disease, and with substance abuse.
Pregnancy or ready to be pregnant and lactating women.
Had previously received systematic MBCT intervention, with no significant effect.

Exclusion criteria for normal controls:

Have negative self-concept or a risk of suicide.
Persons with severe physical disease or central nervous system disease, and with substance abuse.
Pregnancy or ready to be pregnant and lactating women.

Sites / Locations

Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-based Cognitive Therapy

Medication

Arm Description

MBCT group is a treatment group used mindfulness- based cognitive therapy added to the usual medication treatment, and guided by two therapists for 8 sessions. Every group of 6 people can form a closed structural group. Each session lasts 2 hours once a week, and has daily homework assignments.

Medication group is a control group that can choose to use the serotonin reuptake inhibitors (SSRIs) approved by China food and Drug Administration (SFDA) for the treatment of depression (fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram and escitalopram).

Outcomes

Primary Outcome Measures

Change of Hamilton Depression Scale-24 from baseline to 32 weeks

The Hamilton Depression Scale-24 (HAMD-24) is the most common other-rating scale to measure the severity of depression symptoms for adult. It is a clinical instrument with good validity and reliability, and most of the 24 items weighted from 0 to 4.

Secondary Outcome Measures

Change of Hamilton Anxiety Scale from baseline to 32 weeks

The Hamilton Anxiety Scale (HAMA) is a common clinician-administered scale to measure the state of anxiety among adults with anxiety symptoms. There are 14 items of the 5-point rated scale.

Change of Self Compassion Scale from baseline to 32 weeks

The Self Compassion Scale (SCS) is proved to be an instrument featured good characteristics for reliability and validity. There are 26 items divided into 6 Subscales (out of 5 points from almost never to almost always), including self-kindness, self-judgment, common humanity, isolation, mindfulness and over-identification.

Full Information

NCT ID

NCT03558256

First Posted

May 30, 2018

Last Updated

October 11, 2018

Sponsor

Shanghai Mental Health Center

1. Study Identification

Unique Protocol Identification Number

NCT03558256

Brief Title

The Study of Mindfulness-based Cognitive Therapy and Major Depressive Disorder

Official Title

The Study of Mindfulness-based Cognitive Therapy and Major Depressive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 16, 2016 (Actual)

Primary Completion Date

December 31, 2018 (Anticipated)

Study Completion Date

December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of the study is to evaluate the clinical curative effect of mindfulness-based cognitive therapy(MBCT) for major depressive disorder(MDD). Moreover, we will also explore the relationship between P300 potential and erroneous negative potential (ERN) variation and clinical symptoms in MDD and MBCT. This study is a randomized-control trial with two study arms: half of patient cases will receive usual medication treatment with the serotonin reuptake inhibitors (SSRIs) and half of patient cases will receive MBCT added to the usual medication treatment. This study is also a case-control trial, there will be matched normal controls compared with patient cases through a range of psychological scales and electroencephalogram.

Detailed Description

The study is designed as a prospective, assessor-blinded, randomized-control, case-control clinical trial with 70 MDD cases and 35 matched normal controls.After signed the Informed consents, MDD cases will be assigned to two groups randomly by the table generated by Microsoft Excel 2010 to ensure the random distribution between groups. The group of each patient will be allotted by the research coordinator so that evaluators will be blind about it, and patients will be asked to not mention the intervention conditions to evaluators. As the research tools, a range of self-rating scales, other-rating scales and behavioral tests and EEG will be mainly applied to assess clinical symptoms and brain state of participants at baseline (week 0), during the intervention (week 2, 4 and 6), at the end of the intervention (week 8), and during the maintenance phase (week 12, 20 and 32). After 8-week intervention, all of the participants including MDD cases and normal controls will enter the follow-up. Participants of medication group will continue their treatment options without changing the types and doses of medication compared with what they used in the intervention period. MBCT group is the same that participants will maintain their medication treatment and practice MBCT exercises at home.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

Mindfulness-Based Cognitive Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness-based Cognitive Therapy

Arm Type

Experimental

Arm Description

Arm Title

Medication

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness-based Cognitive Therapy

Intervention Description

Patients participating in the experimental group will receive the MBCT intervention besides the usual medication treatment. The intervention is implemented by the manual adapted from the MBCT for Depression (Segal et al. 2013). The modified version of the program has the same structure with the original manual combined the mindfulness training and the cognitive elements from CBT, but the content is more suitable for the Chinese. The instructors in this study are trained and certificated psychiatrists and psychotherapists with rich experience of working with MDD, and they will receive a weekly supervision conducted by a senior supervisor.

Intervention Type

Drug

Intervention Name(s)

Medication

Intervention Description

Both of the MBCT group and the medication group will receive the medication treatment. The initial dose conforms the drug instructions, the dosage can be adjusted once a week, and the maximum dosage should not exceed the maximum amount by the instructions. MDD patients with sleep disorders can use drugs combined with benzodiazepine drugs, but not continuing for more than two weeks; while other psychotropic drugs are not allowed. All of the drugs used in this study are usual clinical drugs with good security, the common adverse reactions include nausea, dry mouth, constipation, diarrhea, indigestion, dizziness, drowsiness, fatigue, sweating, heart palpitations, delayed ejaculation in male, increasing blood aminotransferase without symptoms occasionally and so on.

Primary Outcome Measure Information:

Title

Change of Hamilton Depression Scale-24 from baseline to 32 weeks

Description

Time Frame

baseline (week 0), during the treatment (week 2, 4, 6), end of treatment (week 8), and during the maintenance phase (weeks 12, 20 and 32)

Secondary Outcome Measure Information:

Title

Change of Hamilton Anxiety Scale from baseline to 32 weeks

Description

The Hamilton Anxiety Scale (HAMA) is a common clinician-administered scale to measure the state of anxiety among adults with anxiety symptoms. There are 14 items of the 5-point rated scale.

Time Frame

baseline (week 0), during the treatment (week 2, 4, 6), end of treatment (week 8), and during the maintenance phase (weeks 12, 20 and 32)

Title

Change of Self Compassion Scale from baseline to 32 weeks

Description

Time Frame

baseline (week 0), during the treatment (week 2, 4, 6), end of treatment (week 8), and during the maintenance phase (weeks 12, 20 and 32)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria for patient cases: Male or female, age between 18-55 years. Junior/middle school education or above. Meet the DSM- IV diagnosis of MDD by the evaluation of Chinese version of M.I.N.I. and the clinical diagnosis of one associate chief and above psychiatrist. HAMD24 score ≥ 8. Have not yet accepted psychiatric medication, or had received irregular medication treatment and had discontinued it for 8 weeks. Have enough visual and acoustic ability to complete the inspection required for the study. Each patient should be willing to participate in this study, he/she and his/her guardian must sign the informed consent form after understanding the nature of this study. Inclusion criteria for normal controls: Healthy population matched patient cases in age, sex and education; Male or female; age between 18-55 years; Junior/middle school education or above. Excluded the possibility of mental disorders by the evaluation of Chinese version of M.I.N.I. and the psychiatric interview of one associate chief and above psychiatrist. HAMD24 score < 8; HAMA score < 7. No psychotropic drug history. No history of two lines of three generations of mental disorders. Have enough visual and acoustic ability to complete the inspection required for the study. Each patient should be willing to participate in this study, he/she and his/her guardian must sign the informed consent form after understanding the nature of this study. Exclusion criteria for patient cases: Meet DSM-IV Axis I disorder diagnostic criteria for other psychiatric disorders. Have severe depression symptoms (HAMD24 score > 35), psychotic symptoms, negative self-concept or a risk of suicide. Persons with severe physical disease or central nervous system disease, and with substance abuse. Pregnancy or ready to be pregnant and lactating women. Had previously received systematic MBCT intervention, with no significant effect. Exclusion criteria for normal controls: Have negative self-concept or a risk of suicide. Persons with severe physical disease or central nervous system disease, and with substance abuse. Pregnancy or ready to be pregnant and lactating women.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yifeng Shen, Senior

Phone

13611890930

shenyifeng@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yifeng Shen, Senior

Organizational Affiliation

Shanghai Mental Health Center

Official's Role

Study Director

Facility Information:

Facility Name

Shanghai Mental Health Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200030

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianyin Qiu, Senior

Phone

13524376330

jianyin_qiu@163.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

34381382

Citation

Zhang T, Wang L, Bai Y, Zhao W, Wu Y, Jiang W, Fan Q, Qiu J. Mindfulness-Based Cognitive Therapy in Major Depressive Disorder: A Study Protocol of a Randomized Control Trial and a Case-Control Study With Electroencephalogram. Front Psychiatry. 2021 Jul 26;12:499633. doi: 10.3389/fpsyt.2021.499633. eCollection 2021.

Results Reference

derived

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The Study of Mindfulness-based Cognitive Therapy and Major Depressive Disorder

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