Major Depressive DisorderNCT03558256
The Study of Mindfulness-based Cognitive Therapy and Major Depressive Disorder
A study testing Mindfulness-based Cognitive Therapy and Medication in people with Major Depressive Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Mindfulness-based Cognitive Therapy and Medication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2016to 31 Dec 2018
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Jianyin Qiu, Senior, 13524376330, jianyin_qiu@163.com
About this study
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Mindfulness-based Cognitive Therapy, Medication
- Keywords
- Mindfulness-Based Cognitive Therapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Cognitive TherapyBehavioural
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.
MedicationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start16 May 2016
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yifeng Shen, Senior, Study director, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558256
- Sponsor's protocol ID
- MBCT2018
- Status last verified
- May 2018
- First submitted
- 30 May 2018
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34381382
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Mindfulness-based Cognitive Therapy and Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT03558256
- Acronym / sponsor ID
- MBCT2018
- Conditions
- Major Depressive Disorder
- Keywords
- Mindfulness-Based Cognitive Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 16 May 2016 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 15 Jun 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Cognitive Therapy | Experimental | Behavioral: Mindfulness-based Cognitive Therapy, Drug: MedicationMBCT 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 | Active comparator | Drug: MedicationMedication 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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Mindfulness-based Cognitive TherapyPatients 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. | Behavioural | Mindfulness-based Cognitive Therapy |
| MedicationBoth 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. | Drug | Medication, Mindfulness-based Cognitive Therapy |
Primary outcome
Change of Hamilton Depression Scale-24 from baseline to 32 weeks
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)
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.
2 secondary outcomes
Change of Hamilton Anxiety Scale from baseline to 32 weeks
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)
Change of Self Compassion Scale from baseline to 32 weeks
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Derived from this study: PubMed 34381382Zhang 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.
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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.
Yifeng Shen, Senior study director
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Cognitive Therapy and Medication in people with Major Depressive Disorder, run by Shanghai Mental Health Center at 1 site in China.
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 14 inclusion and 8 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 15 Oct 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 China. 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. 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 Yifeng Shen, Senior (13611890930, shenyifeng@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Hamilton Depression Scale-24 from baseline to 32 weeks (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03558256, which also lists 1 linked publication.
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 15 Oct 2018.