Mindfulness Based Cognitive Therapy for Recurrent Depression

Depressive Disorder, Major Clinical Trial

Official title:

Mindfulness Based Cognitive Therapy for Patients With Recurrent Depression: a Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01038765
• Other study ID #: MFN-2005-2010
• Secondary ID: 2005 6028
• Status: Completed
• Phase: N/A
• Start date: January 2005
• Est. completion date: January 2011

Study information

• Verified date: January 2024
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: January 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Behavioral:
• Mindfulness Based Cognitive Therapy
8-weeks group based intervention of mindfulness and cognitive behavioural techniques

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Center	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Fonds Psychische Gezondheid

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive Symptoms	Hamilton Depression Rating Scale. The HAMD is a standardized 17-item interview to measure number and severity of depressive symptoms on a 0-52 score.; Higher values indicate a worse outcome. Specifical, HAMD scores can be interpreted as "no depression" (0-7), "mild depression" (8-16), "moderate depression" (17-23) and "severe depression" (24-52).	Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis.
Secondary	Self-report Depressive Symptoms	Beck Depression Inventory (BDI), a 21-item self-report questionnaire to measure depressive symptoms, score range 0-63.; Higher scores indicate a worse outcome. Specifically, BDI scores can be interpreted as "minimal depression" (0-13), "mild depression" (14-19), "moderate depression" (20-28) and "severe depression" (29-63).	Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis