Mindfulness-based Behavioural Therapy (MIBT) Versus Psychodynamic Therapy for Patients With Major Depressive Disorder in Psychotherapeutic Day Treatment. A Randomised Clinical Pilot Trial (Mipsy)
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)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Zeeland
-
Roskilde, Zeeland, Dinamarca, 4000
- Reclutamiento
- The day clinic for treatment of non-psychotic disorders (Roskilde Psychiatry)
-
Contacto:
- Erik Simonsen, Associate professor
- Número de teléfono: +4547327733
- Correo electrónico: es@regionsjaelland.dk
-
Contacto:
- Kirsten Larsen, Medical doctor
- Número de teléfono: 47327733
- Correo electrónico: kala@regionsjaelland.dk
-
Investigador principal:
- Janus Christian Jakobsen
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Aged 18 to 65 years
- Major depressive disorder (SCID I).
- BDI II > 13.
- Written informed consent.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
|
Comparador activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
17 item Hamilton rating scale for depression (score at the end of 18 weeks of day- treatment)
Periodo de tiempo: 0 weeks, 18 weeks, and 1 year
|
0 weeks, 18 weeks, and 1 year
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
SCL-90-R (GSI score at the end of 18 weeks of day- treatment)
Periodo de tiempo: 0 weeks, 9 weeks, 18 weeks, and 1 year
|
0 weeks, 9 weeks, 18 weeks, and 1 year
|
|
The proportion of patients who achieve remission (Hamilton score < 8).
Periodo de tiempo: 0 weeks, 18 weeks, and 1 year
|
0 weeks, 18 weeks, and 1 year
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Mipsy trial
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Trastorno depresivo mayor
-
University of Maryland, College ParkTerminadoMajor evento cardíaco adverso (MACE)Estados Unidos
Ensayos clínicos sobre Mindfulness-based Behavioural Therapy (MIBT)
-
Mackay Medical CollegeTerminadoProblema de salud mentalTaiwán
-
University Hospital, BordeauxTerminadoEnfermedad de ParkinsonFrancia
-
Universidad de GranadaChair in Conscience and Development (UGR); Mind, Brain and Behaviour Research...TerminadoAnsiedad | Trastorno sicologico | Perfeccionismo | Atención | Empatía | Creatividad | Estrés de la vida | Inteligencia emocionalEspaña