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

NCT03558256 | Unknown

• 1 other identifier: MBCT2018
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Mindfulness-Based Cognitive Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (2)

• Change of Hamilton Anxiety Scale from baseline to 32 weeks

  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)

• Change of Self Compassion Scale from baseline to 32 weeks

  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)

Study Arms (2)

Mindfulness-based Cognitive Therapy

EXPERIMENTAL

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.

Behavioral: Mindfulness-based Cognitive Therapy; Drug: Medication

Medication

ACTIVE COMPARATOR

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).

Drug: Medication

Interventions

Mindfulness-based Cognitive Therapy BEHAVIORAL

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.

Mindfulness-based Cognitive Therapy

Medication DRUG

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.

Medication; Mindfulness-based Cognitive Therapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 34381382 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Mindfulness-Based Cognitive Therapy; Dosage Forms

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Yifeng Shen, Senior

  Shanghai Mental Health Center

  STUDY DIRECTOR

Central Study Contacts

Yifeng Shen, Senior

CONTACT

13611890930; shenyifeng@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 15, 2018
• Study Start: May 16, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-05

Locations

CN (1)