Obsessive-Compulsive DisorderNCT03179839
The Study of Mindfulness Based Cognitive Therapy and Obsessive-Compulsive Disorder
A study testing Mindfulness-based Cognitive Therapy, Psycho-education Program and sertraline, fluvoxamine in people with Obsessive-Compulsive 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 MBCT to reduce obsessive and compulsive symptoms. Moreover, the investigators will also explore a MBCT manual for Chinese patients with OCD, which can be widely applied to the clinical practice. There are two parts of the study. Read more about this study
- Who is it for?
- Ages 18 to 54 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Mindfulness-based Cognitive Therapy, Psycho-education Program and sertraline, fluvoxamine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2017to 20 Jul 2019
- 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 54 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants should suffer from clinically OCD symptoms and have a DSM-IV Axis Ⅰ diagnosis of OCD (M.I.N.I.)
- 12≤ Y-BOCS score ≤25
- Male or female, 18 years old to 54 years of age
- Junior middle school education or above
- Have not yet accepted psychiatric medication, or had received irregular medication treatment and have been discontinued 8 weeks
- Have enough visual and acoustic ability to complete the inspection required for the study
- Each patient and his guardian must understand the nature of this study and sign the informed consent form
Who cannot join
- meet DSM-IV Axis Ⅰ diagnostic criteria for other psychiatric disorders
- persons with severe physical disease or central nervous system disease
- have a strong negative concept or a high risk of suicide
- substance abuse, pregnancy or the preparation of recently pregnant women and lactating women
- severe obsessive compulsive symptoms, so that patients can not complete the required assessment and treatment intervention
- at the same time to accept MECT or other psychological therapy
- patients had previously received treatment of mindfulness-based intervention, and no significant effect
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of the study is to evaluate the clinical curative effect of MBCT to reduce obsessive and compulsive symptoms. Moreover, the investigators will also explore a MBCT manual for Chinese patients with OCD, which can be widely applied to the clinical practice.
There are two parts of the study. The first part is a qualitative research with two pilot MBCT groups. The second part of this study is a single-blind randomized controlled trial with three study arms: one - third of participants receive group mindfulness-based cognitive therapy led by trained MBCT psychotherapists or psychiatrists in addition to medication, one - third of participants receive group psycho-education program and one - third of participants receive drug therapy as usual. All participants have 10 sessions intervention and assessments.
Read the detailed description
The qualitative research will use grounded theory path to interview therapists and patients for 60 minutes in the baseline, after 5 weeks treatments and after the 10 weeks treatments. The subjective experience of the therapists and patients in two pilot MBCT groups will be described and explained. And the entire process of treatments will be participatory observed.
In the second part of the study, all patients will take blood test and functional magnetic resonance imaging (fMRI) scan in the baseline and after 10 weeks, to gather data in genetics and imaging features, which can help the study to discover biological indicators of the curative effect. And after the patients and their custodians signed the consent form, all of participants will be blindly assigned to three groups by a predetermined random table which is generated by Microsoft Excel 2010 for ensuring randomly fair distribution across conditions. The investigators will not decode these numbers until the intervention group is assigned.
As the research tools, a range of self-rating scales, other-rating scales and behavioral and physiological measures will be mainly applied to assess clinical symptoms of participants at baseline (week 0), mid-treatment (week 4), at the end of acute treatment (week 10), and during the maintenance phase (week 14, 22 and 34).
After 10 sessions, all the participants including the non-responders and the responders (ie, decrease in Yale-Brown Obsessive Compulsive Scale [YBOCS] scores ≥ 25%) will enter the maintenance phase for 6 months. The participants in MBCT group will continue MBCT treatments at home. The participants in drug therapy group will continue on their treatment program without changing the type and dosage of medication they have been using. By comparing clinical symptoms, such as obsessive and compulsive symptoms, anxiety, depression, quality of life and other clinical symptoms and behavior, the study will describe the short-term and long-term effects of MBCT in patients with DSM-IV obsessive-compulsive disorder (OCD).
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Mindfulness-based Cognitive Therapy, Psycho-education Program, sertraline, fluvoxamine
- Keywords
- Mindfulness-Based Cognitive Therapy
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Cognitive TherapyBehavioural
The intervention will be carried out according to the handbook of the Dr. Didonna. There is a Session Agenda from Dr. Didonna for the use of the Instructor and session handouts for the participants. Some records of mindfulness practices will be given to participants for facilitating practice between sessions. Before each session, the instructor needs to review the session agenda and prepare copies of handouts for participants.
MBCT instructors were experienced psychotherapists and psychiatrists with several years' expertise in OCD treatment. They had been trained by one of the founders of MBCT, Mark Williams and the founder of MBCT for OCD, Fabrizio Didonna. Supervision will be provided by Dr.Didonna.
Psycho-education ProgramBehavioural
As a widely used placebo control condition, the Psycho-Education Program can play an active role through the psychological suggestion and forward thinking mostly. It is designed to be similar with MBCT in level of structure, setting and other non-specific effects of psychological intervention. All instructors will be qualified graduate students who major in clinical psychology with training in cognitive behavioral therapy and psychodynamic therapy.
sertraline, fluvoxamineDrug
The participants can be adjustable once a week dose and the maximum dose does not exceed the maximum amount of instructions. And benzodiazepine drugs also can be used by the OCD patients with sleep disorders, but not be used continuously for more than two weeks. Besides this, other psychotropic drugs are not allowed to use. The use of drugs in this study are commonly used drugs with good safety, and its common adverse reactions include dry mouth, constipation, nausea, indigestion, dizziness, fatigue, sweating 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, and guided by two therapists for 10 sessions. Every collection of about 6-8 patients is a closed structural group. Each session lasts 2.5 hours once a week, and has daily homework assignments. Receives: Behavioral: Mindfulness-based Cognitive Therapy |
| Psycho-education Program | Placebo comparator | The program is consists of the information and principle of treatment for OCD, group sharing, supporting and discussion. Receives: Behavioral: Psycho-education Program |
| SSRIs Therapy | Active comparator | This is a control group that can choose to use SSRI drugs which the SFDA approved for the treatment of OCD (Sertraline, Fluvoxamine, initial dose of 50 mg). Receives: Drug: sertraline, fluvoxamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive-Compulsive Scale
Yale-Brown Obsessive-Compulsive Scale is a medical semi-structured questionnaire with a total of 10 items that measure the severity of Obsessive thinking and compulsive behavior on a scale of 0 = None; 1 = Sub-threshold; 2 =Mild; 3 =Moderate; and 4 = Severe. The total score is to be got by adding every score of all the items. And the higher the score is, the more severe OC symptoms are.
Measured: Change from baseline up to week 34
Secondary outcomes (2)
Hamilton Anxiety Scale
Hamilton Anxiety Scale is the most common other-rating scale for clinical assessment of anxiety status and suitable for adults with anxiety symptoms. There are 14 items with each symptom rated on a five-point Scale.
Measured: Change from baseline up to week 34
Hamilton Depression Scale-24
Hamilton Depression Scale-24 is the most common other-rating scale for clinically assessing the state of depression and suitable for adults with depressive symptoms. There are 24 items rated to each symptom and most of the items used 0 to 4 points.
Measured: Change from baseline up to week 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start20 Jan 2017
- Primary completion20 Nov 2018
- Study completion20 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- 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
- Investigator
- Enrolment
- 123 participants (actual)
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
- NCT03179839
- Sponsor's protocol ID
- MBCT2017
- Status last verified
- Jan 2020
- First submitted
- 14 May 2017
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Mindfulness Based Cognitive Therapy and Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT03179839
- Acronym / sponsor ID
- MBCT2017
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Mindfulness-Based Cognitive Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 7 Jun 2017 (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 MBCT to reduce obsessive and compulsive symptoms. Moreover, the investigators will also explore a MBCT manual for Chinese patients with OCD, which can be widely applied to the clinical practice.
There are two parts of the study. The first part is a qualitative research with two pilot MBCT groups. The second part of this study is a single-blind randomized controlled trial with three study arms: one - third of participants receive group mindfulness-based cognitive therapy led by trained MBCT psychotherapists or psychiatrists in addition to medication, one - third of participants receive group psycho-education program and one - third of participants receive drug therapy as usual. All participants have 10 sessions intervention and assessments.
Detailed description
The qualitative research will use grounded theory path to interview therapists and patients for 60 minutes in the baseline, after 5 weeks treatments and after the 10 weeks treatments. The subjective experience of the therapists and patients in two pilot MBCT groups will be described and explained. And the entire process of treatments will be participatory observed.
In the second part of the study, all patients will take blood test and functional magnetic resonance imaging (fMRI) scan in the baseline and after 10 weeks, to gather data in genetics and imaging features, which can help the study to discover biological indicators of the curative effect. And after the patients and their custodians signed the consent form, all of participants will be blindly assigned to three groups by a predetermined random table which is generated by Microsoft Excel 2010 for ensuring randomly fair distribution across conditions. The investigators will not decode these numbers until the intervention group is assigned.
As the research tools, a range of self-rating scales, other-rating scales and behavioral and physiological measures will be mainly applied to assess clinical symptoms of participants at baseline (week 0), mid-treatment (week 4), at the end of acute treatment (week 10), and during the maintenance phase (week 14, 22 and 34).
After 10 sessions, all the participants including the non-responders and the responders (ie, decrease in Yale-Brown Obsessive Compulsive Scale [YBOCS] scores ≥ 25%) will enter the maintenance phase for 6 months. The participants in MBCT group will continue MBCT treatments at home. The participants in drug therapy group will continue on their treatment program without changing the type and dosage of medication they have been using. By comparing clinical symptoms, such as obsessive and compulsive symptoms, anxiety, depression, quality of life and other clinical symptoms and behavior, the study will describe the short-term and long-term effects of MBCT in patients with DSM-IV obsessive-compulsive disorder (OCD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Cognitive Therapy | Experimental | Behavioral: Mindfulness-based Cognitive TherapyMBCT group is a treatment group used mindfulness-based cognitive therapy, and guided by two therapists for 10 sessions. Every collection of about 6-8 patients is a closed structural group. Each session lasts 2.5 hours once a week, and has daily homework assignments. |
| Psycho-education Program | Placebo comparator | Behavioral: Psycho-education ProgramThe program is consists of the information and principle of treatment for OCD, group sharing, supporting and discussion. |
| SSRIs Therapy | Active comparator | Drug: sertraline, fluvoxamineThis is a control group that can choose to use SSRI drugs which the SFDA approved for the treatment of OCD (Sertraline, Fluvoxamine, initial dose of 50 mg). |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants should suffer from clinically OCD symptoms and have a DSM-IV Axis Ⅰ diagnosis of OCD (M.I.N.I.)
- 12≤ Y-BOCS score ≤25
- Male or female, 18 years old to 54 years of age
- Junior middle school education or above
- Have not yet accepted psychiatric medication, or had received irregular medication treatment and have been discontinued 8 weeks
Key exclusion criteria (7 listed)
- meet DSM-IV Axis Ⅰ diagnostic criteria for other psychiatric disorders
- persons with severe physical disease or central nervous system disease
- have a strong negative concept or a high risk of suicide
- substance abuse, pregnancy or the preparation of recently pregnant women and lactating women
- severe obsessive compulsive symptoms, so that patients can not complete the required assessment and treatment intervention
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 TherapyThe intervention will be carried out according to the handbook of the Dr. Didonna. There is a Session Agenda from Dr. Didonna for the use of the Instructor and session handouts for the participants. Some records of mindfulness practices will be given to participants for facilitating practice between sessions. Before each session, the instructor needs to review the session agenda and prepare copies of handouts for participants. MBCT instructors were experienced psychotherapists and psychiatrists with several years' expertise in OCD treatment. They had been trained by one of the founders of MBCT, Mark Williams and the founder of MBCT for OCD, Fabrizio Didonna. Supervision will be provided by Dr.Didonna. | Behavioural | Mindfulness-based Cognitive Therapy |
| Psycho-education ProgramAs a widely used placebo control condition, the Psycho-Education Program can play an active role through the psychological suggestion and forward thinking mostly. It is designed to be similar with MBCT in level of structure, setting and other non-specific effects of psychological intervention. All instructors will be qualified graduate students who major in clinical psychology with training in cognitive behavioral therapy and psychodynamic therapy. | Behavioural | Psycho-education Program |
| sertraline, fluvoxamineThe participants can be adjustable once a week dose and the maximum dose does not exceed the maximum amount of instructions. And benzodiazepine drugs also can be used by the OCD patients with sleep disorders, but not be used continuously for more than two weeks. Besides this, other psychotropic drugs are not allowed to use. The use of drugs in this study are commonly used drugs with good safety, and its common adverse reactions include dry mouth, constipation, nausea, indigestion, dizziness, fatigue, sweating and so on. | Drug | SSRIs Therapy |
Primary outcome
Yale-Brown Obsessive-Compulsive Scale
Time frame: Change from baseline up to week 34
Yale-Brown Obsessive-Compulsive Scale is a medical semi-structured questionnaire with a total of 10 items that measure the severity of Obsessive thinking and compulsive behavior on a scale of 0 = None; 1 = Sub-threshold; 2 =Mild; 3 =Moderate; and 4 = Severe. The total score is to be got by adding every score of all the items. And the higher the score is, the more severe OC symptoms are.
2 secondary outcomes
Hamilton Anxiety Scale
Time frame: Change from baseline up to week 34
Hamilton Depression Scale-24
Time frame: Change from baseline up to week 34
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Individual participant dataSharing planned: No
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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, Psycho-education Program and sertraline, fluvoxamine in people with Obsessive-Compulsive 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 7 Jan 2020. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale-Brown Obsessive-Compulsive Scale (time frame: Change from baseline up to week 34). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2020.