Major Depressive DisorderMipsyNCT01070134
Mindfulness-based Behavioural Therapy (MIBT) Versus Psychodynamic Therapy for Patients With Major Depressive Disorder in Psychotherapeutic Day Treatment. A Randomised Clinical Pilot Trial
A study testing Mindfulness-based Behavioural Therapy (MIBT) and PT (psychodynamic therapy) in people with Major Depressive Disorder and Personality Disorder, run by Psychiatry Roskilde at 1 site in Denmark.
Trial summary
Background: According to the WHO, major depressive disorder is the second largest healthcare problem worldwide in terms of disability caused by illness. It afflicts an estimated 17% of individuals during their lifetimes at tremendous costs. A number of depressive patients are treated with antidepressant medication. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Personality Disorder
- What is being tested?
- Mindfulness-based Behavioural Therapy (MIBT) and PT (psychodynamic therapy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2010to Aug 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years
- Major depressive disorder (SCID I).
- BDI II > 13.
- Written informed consent.
Who cannot join
- Current psychosis, diagnosis of schizophrenia or schizotypal personality disorder (DSM IV-TR).
- Alcohol or substance abuse judged to require treatment in preference to depression (assessed during patient conference).
- Commenced or changed psychopharmacological treatment less than six weeks before randomisation.
- Pregnancy.
- No written informed consent.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
The day clinic for treatment of non-psychotic disorders (Roskilde Psychiatry)
Roskilde, Region Sjælland, 4000
Erik Simonsen, Associate professor, +4547327733, es@regionsjaelland.dk
Kirsten Larsen, Medical doctor, 47327733, kala@regionsjaelland.dk
About this study
Background:
According to the WHO, major depressive disorder is the second largest healthcare problem worldwide in terms of disability caused by illness. It afflicts an estimated 17% of individuals during their lifetimes at tremendous costs. A number of depressive patients are treated with antidepressant medication. The efficacy of antidepressant medication has been studied in a number of systematic reviews, and in recent years some of these reviews have shown that the efficacy is questionable for many patients. So are there other effective treatments for this serious illness?
Read more
Cognitive- and psychodynamic therapies are probably both significantly more effective for depression than no treatment, but only limited comparisons have been made between the two interventions. A Cochrane review shows that cognitive therapy has a preventive effect against recurrent depression, and that this effect may surpass the preventive effect of antidepressant medication. Mindfulness training may be an effective technique in preventing relapse in patients who have had at least 3 previous depressive episodes. But efficacy in treating currently depressed patients has not been studied.
Objective To perform a randomised clinical trial with blinded assessment of efficacy variables in order to study the effects of mindfulness based behavioral therapy (cognitive therapy and mindfulness) versus psychodynamic therapy in depressive patients.
Methods
A randomised clinical trial of 84 consecutive patients diagnosed with major depressive disorder, referred to the day clinic, Roskilde psychiatric services. The patients will be randomised to one of two interventions:
- MIBT (mindfulness-based behavioural therapy)
- PT (psychodynamic therapy)
- Conditions
- Major Depressive Disorder, Personality Disorder
- Being tested
- Mindfulness-based Behavioural Therapy (MIBT), PT (psychodynamic therapy)
- Medical subject headings
- Depressive Disorder, Major, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Behavioural Therapy (MIBT)Behavioural
The MIBT treatment consists of weekly individual MIBT therapy (45-50 min.), together with weekly mindfulness-skills training group (1.5 hours).
The treatment is based on the cognitive model of depression, but will, based on concrete problems, draw from alternative cognitive techniques in order to treat personality-related problems and will use elements from mindfulness.
PT (psychodynamic therapy)Behavioural
The PT treatment consists of weekly individual PT therapy (45-50 min.), together with weekly PT group therapy (1.5 hours).
The main elements of PT are the free-flowing, non-therapist guided dialogue, based on classic psychoanalytical free association. Basically, the role of the therapist is to set ground rules and organise the time, place and duration, to maintain a proper tone, and ultimately to ensure that a therapeutic process takes place using relevant interventions.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based Behavioural Therapy (MIBT) | Experimental | Not described Receives: Behavioral: Mindfulness-based Behavioural Therapy (MIBT) |
| PT (psychodynamic therapy) | Active comparator | Not described Receives: Behavioral: PT (psychodynamic therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
17 item Hamilton rating scale for depression (score at the end of 18 weeks of day- treatment)
Measured: 0 weeks, 18 weeks, and 1 year
Secondary outcomes (2)
SCL-90-R (GSI score at the end of 18 weeks of day- treatment)
Measured: 0 weeks, 9 weeks, 18 weeks, and 1 year
The proportion of patients who achieve remission (Hamilton score < 8).
Measured: 0 weeks, 18 weeks, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive 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
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psychiatry Roskilde
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070134
- Sponsor's protocol ID
- Mipsy trial
- Acronym
- Mipsy
- Status last verified
- Feb 2010
- First submitted
- 16 Feb 2010
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jakobsen JC, Gluud C, Kongerslev M, Larsen KA, Sorensen P, Winkel P, Lange T, Sogaard U, Simonsen E. Third-wave cognitive therapy versus mentalisation-based treatment for major depressive disorder: a randomised clinical trial. BMJ Open. 2014 Aug 19;4(8):e004903. doi: 10.1136/bmjopen-2014-004903.
PubMed 25138802Jakobsen JC, Gluud C, Kongerslev M, Larsen KA, Sorensen P, Winkel P, Lange T, Sogaard U, Simonsen E. 'Third wave' cognitive therapy versus mentalization-based therapy for major depressive disorder. A protocol for a randomised clinical trial. BMC Psychiatry. 2012 Dec 19;12:232. doi: 10.1186/1471-244X-12-232.
PubMed 23253305
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Behavioural Therapy (MIBT) Versus Psychodynamic Therapy for Patients With Major Depressive Disorder in Psychotherapeutic Day Treatment. A Randomised Clinical Pilot Trial
- ClinicalTrials.gov ID
- NCT01070134
- Acronym / sponsor ID
- Mipsy / Mipsy trial
- Conditions
- Major Depressive Disorder, Personality Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Psychiatry RoskildeIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 17 Feb 2010 (estimated)
- 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.
Background:
According to the WHO, major depressive disorder is the second largest healthcare problem worldwide in terms of disability caused by illness. It afflicts an estimated 17% of individuals during their lifetimes at tremendous costs. A number of depressive patients are treated with antidepressant medication. The efficacy of antidepressant medication has been studied in a number of systematic reviews, and in recent years some of these reviews have shown that the efficacy is questionable for many patients. So are there other effective treatments for this serious illness?
Cognitive- and psychodynamic therapies are probably both significantly more effective for depression than no treatment, but only limited comparisons have been made between the two interventions. A Cochrane review shows that cognitive therapy has a preventive effect against recurrent depression, and that this effect may surpass the preventive effect of antidepressant medication. Mindfulness training may be an effective technique in preventing relapse in patients who have had at least 3 previous depressive episodes. But efficacy in treating currently depressed patients has not been studied.
Objective To perform a randomised clinical trial with blinded assessment of efficacy variables in order to study the effects of mindfulness based behavioral therapy (cognitive therapy and mindfulness) versus psychodynamic therapy in depressive patients.
Methods
A randomised clinical trial of 84 consecutive patients diagnosed with major depressive disorder, referred to the day clinic, Roskilde psychiatric services. The patients will be randomised to one of two interventions:
- MIBT (mindfulness-based behavioural therapy)
- PT (psychodynamic therapy)
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 Behavioural Therapy (MIBT) | Experimental | Behavioral: Mindfulness-based Behavioural Therapy (MIBT) |
| PT (psychodynamic therapy) | Active comparator | Behavioral: PT (psychodynamic therapy) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 to 65 years
- Major depressive disorder (SCID I).
- BDI II > 13.
- Written informed consent.
Key exclusion criteria (5 listed)
- Current psychosis, diagnosis of schizophrenia or schizotypal personality disorder (DSM IV-TR).
- Alcohol or substance abuse judged to require treatment in preference to depression (assessed during patient conference).
- Commenced or changed psychopharmacological treatment less than six weeks before randomisation.
- Pregnancy.
- No written informed consent.
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 Behavioural Therapy (MIBT)The MIBT treatment consists of weekly individual MIBT therapy (45-50 min.), together with weekly mindfulness-skills training group (1.5 hours). The treatment is based on the cognitive model of depression, but will, based on concrete problems, draw from alternative cognitive techniques in order to treat personality-related problems and will use elements from mindfulness. | Behavioural | Mindfulness-based Behavioural Therapy (MIBT) |
| PT (psychodynamic therapy)The PT treatment consists of weekly individual PT therapy (45-50 min.), together with weekly PT group therapy (1.5 hours). The main elements of PT are the free-flowing, non-therapist guided dialogue, based on classic psychoanalytical free association. Basically, the role of the therapist is to set ground rules and organise the time, place and duration, to maintain a proper tone, and ultimately to ensure that a therapeutic process takes place using relevant interventions. | Behavioural | PT (psychodynamic therapy) |
Primary outcome
17 item Hamilton rating scale for depression (score at the end of 18 weeks of day- treatment)
Time frame: 0 weeks, 18 weeks, and 1 year
2 secondary outcomes
SCL-90-R (GSI score at the end of 18 weeks of day- treatment)
Time frame: 0 weeks, 9 weeks, 18 weeks, and 1 year
The proportion of patients who achieve remission (Hamilton score < 8).
Time frame: 0 weeks, 18 weeks, and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
- Derived from this study: PubMed 25138802Jakobsen JC, Gluud C, Kongerslev M, Larsen KA, Sorensen P, Winkel P, Lange T, Sogaard U, Simonsen E. Third-wave cognitive therapy versus mentalisation-based treatment for major depressive disorder: a randomised clinical trial. BMJ Open. 2014 Aug 19;4(8):e004903. doi: 10.1136/bmjopen-2014-004903.
- Derived from this study: PubMed 23253305Jakobsen JC, Gluud C, Kongerslev M, Larsen KA, Sorensen P, Winkel P, Lange T, Sogaard U, Simonsen E. 'Third wave' cognitive therapy versus mentalization-based therapy for major depressive disorder. A protocol for a randomised clinical trial. BMC Psychiatry. 2012 Dec 19;12:232. doi: 10.1186/1471-244X-12-232.
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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.
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 Behavioural Therapy (MIBT) and PT (psychodynamic therapy) in people with Major Depressive Disorder and Personality Disorder, run by Psychiatry Roskilde at 1 site in Denmark.
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 4 inclusion and 5 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 8 Jun 2011. 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 Denmark. 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 Janus Christian Jakobsen, Medical doctor (+45 26186242, janusjakobsen@mac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
17 item Hamilton rating scale for depression (score at the end of 18 weeks of day- treatment) (time frame: 0 weeks, 18 weeks, and 1 year). 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 NCT01070134, which also lists 2 linked publications.
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 8 Jun 2011.