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

Major Depressive Disorder Clinical Trial

— Mipsy  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01070134
• Other study ID #: Mipsy trial
• Status: Recruiting
• Phase: N/A
• First received: February 16, 2010
• Last updated: June 6, 2011
• Start date: February 2010
• Est. completion date: August 2011

Study information

• Verified date: February 2010
• Source: Psychiatry Roskilde
• Contact: Janus Christian Jakobsen, Medical doctor
• Phone: +45 26186242
• Email: janusjakobsen[@]mac.com
• Is FDA regulated: No
• Health authority: Danish Data Protection Agency (nr.: 2008-58-0020).
• Study type: Interventional

Clinical 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. 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Personality Disorder
• Personality Disorders

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Denmark	The day clinic for treatment of non-psychotic disorders (Roskilde Psychiatry)	Roskilde	Zeeland

Sponsors (1)

Lead Sponsor	Collaborator
Psychiatry Roskilde

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	17 item Hamilton rating scale for depression (score at the end of 18 weeks of day- treatment)		0 weeks, 18 weeks, and 1 year	No
Secondary	SCL-90-R (GSI score at the end of 18 weeks of day- treatment)		0 weeks, 9 weeks, 18 weeks, and 1 year	No
Secondary	The proportion of patients who achieve remission (Hamilton score < 8).		0 weeks, 18 weeks, and 1 year	No