Clinical trial NCT01070134: Mindfulness-based Behavioural Therapy (MIBT) Versus Psychodynamic Therapy for Patients With Major Depressive Disorder in Psychotherapeutic Day Treatment. A Randomised Clinical Pilot Trial
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Personality Disorder
Lead sponsor: Psychiatry Roskilde
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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:

1. MIBT (mindfulness-based behavioural therapy)
2. PT (psychodynamic therapy)


Eligibility criteria: Inclusion Criteria:

1. Aged 18 to 65 years
2. Major depressive disorder (SCID I).
3. BDI II \> 13.
4. Written informed consent.

Exclusion Criteria:

1. Current psychosis, diagnosis of schizophrenia or schizotypal personality disorder (DSM IV-TR).
2. Alcohol or substance abuse judged to require treatment in preference to depression (assessed during patient conference).
3. Commenced or changed psychopharmacological treatment less than six weeks before randomisation.
4. Pregnancy.
5. No written informed consent.

Primary outcomes:
measure: 17 item Hamilton rating scale for depression (score at the end of 18 weeks of day- treatment)
timeFrame: 0 weeks, 18 weeks, and 1 year
Secondary outcomes:
measure: SCL-90-R (GSI score at the end of 18 weeks of day- treatment)
timeFrame: 0 weeks, 9 weeks, 18 weeks, and 1 year
measure: The proportion of patients who achieve remission (Hamilton score < 8).
timeFrame: 0 weeks, 18 weeks, and 1 year
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: The day clinic for treatment of non-psychotic disorders (Roskilde Psychiatry)
state: Zeeland
Study officials:
References:
citation: 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.
citation: Jakobsen 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.