Clinical trial NCT01038765: Mindfulness Based Cognitive Therapy for Recurrent Depression
Official title: Mindfulness Based Cognitive Therapy for Patients With Recurrent Depression: a Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder, Major
Keywords: Recurrent Major Depressive Disorder
Mindfulness Based Cognitive Therapy
Randomized Controlled Trial
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Fonds Psychische Gezondheid
First posted: 2009-12-24
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effectiveness and possible mediating factors of Mindfulness Based Cognitive Therapy (MBCT) for recurrent depression.

Detailed description: Mindfulness Based Cognitive Therapy (MBCT) is a 8 session group intervention and is well described by several authors.

Previous studies showed Mindfulness Based Cognitive Therapy (MBCT) to be effective to prevent relapse in patients with recurrent depression and 3 or more previous depressive episodes.

Study aims are:

1. to replicate previous findings in The Netherlands, by a research team which did not develop the intervention
2. to investigate if MBCT is applicable for patients with recurrent depression and current depressive symptoms
3. to examine possible mediators of treatment effect and predictors of relapse in the year following the treatment

In this study, patients are randomly assigned to a MBCT intervention group or a waiting list control group. Patients allocated to the waiting list control condition will receive the MBCT course three months later. All patients who participated in a MBCT training will be assessed during the year following the completion of the MBCT course. We aim to include about 220 patients.

Eligibility criteria: Inclusion Criteria:

* 3 or more previous depressive episodes
* if treated with medication: constant dose of at least 6 weeks

Exclusion Criteria:

* Bipolar Disorder
* Psychotic disorder
* Neurological or somatic illness affecting depression or outcome measures
* Current alcohol or drugs dependency
* Acute need of psychiatric treatment

Primary outcomes:
measure: Depressive Symptoms
timeFrame: Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis.
Secondary outcomes:
measure: Self-report Depressive Symptoms
timeFrame: Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Anne EM Speckens, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23. doi: 10.1037//0022-006x.68.4.615.
citation: Ma SH, Teasdale JD. Mindfulness-based cognitive therapy for depression: replication and exploration of differential relapse prevention effects. J Consult Clin Psychol. 2004 Feb;72(1):31-40. doi: 10.1037/0022-006X.72.1.31.
citation: Barnhofer T, Crane C, Hargus E, Amarasinghe M, Winder R, Williams JM. Mindfulness-based cognitive therapy as a treatment for chronic depression: A preliminary study. Behav Res Ther. 2009 May;47(5):366-73. doi: 10.1016/j.brat.2009.01.019. Epub 2009 Feb 5.
citation: Kenny MA, Williams JM. Treatment-resistant depressed patients show a good response to Mindfulness-based Cognitive Therapy. Behav Res Ther. 2007 Mar;45(3):617-25. doi: 10.1016/j.brat.2006.04.008. Epub 2006 Jun 23.
citation: Kingston T, Dooley B, Bates A, Lawlor E, Malone K. Mindfulness-based cognitive therapy for residual depressive symptoms. Psychol Psychother. 2007 Jun;80(Pt 2):193-203. doi: 10.1348/147608306X116016.
citation: van Aalderen JR, Donders AR, Giommi F, Spinhoven P, Barendregt HP, Speckens AE. The efficacy of mindfulness-based cognitive therapy in recurrent depressed patients with and without a current depressive episode: a randomized controlled trial. Psychol Med. 2012 May;42(5):989-1001. doi: 10.1017/S0033291711002054. Epub 2011 Oct 3.