Mindfulness-based Behavioural Therapy (MIBT) Versus Psychodynamic Therapy for Patients With Major Depressive Disorder in Psychotherapeutic Day Treatment. A Randomised Clinical Pilot Trial (Mipsy)

Psychiatry Roskilde

Status: Unknown

Conditions: Personality Disorder; Major Depressive Disorder

Treatments: Behavioral: PT (psychodynamic therapy); Behavioral: Mindfulness-based Behavioural Therapy (MIBT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01070134

Mipsy trial

Details and patient eligibility

About

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)

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Mindfulness-based Behavioural Therapy (MIBT)

Experimental group

Treatment:

Behavioral: Mindfulness-based Behavioural Therapy (MIBT)

PT (psychodynamic therapy)

Active Comparator group

Treatment:

Behavioral: PT (psychodynamic therapy)