NCT01038765

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
13.1 years until next milestone

Results Posted

Study results publicly available

January 30, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

5.2 years

First QC Date

December 22, 2009

Results QC Date

January 25, 2021

Last Update Submit

January 29, 2024

Conditions

Keywords

Recurrent Major Depressive DisorderMindfulness Based Cognitive TherapyRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Self-report Depressive Symptoms

    Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis

Study Arms (2)

Mindfulness Based Cognitive Therapy

EXPERIMENTAL

Mindfulness Based Cognitive Therapy

Behavioral: Mindfulness Based Cognitive Therapy

Waiting list control group

NO INTERVENTION

3-month waiting list group

Interventions

8-weeks group based intervention of mindfulness and cognitive behavioural techniques

Also known as: MBCT
Mindfulness Based Cognitive Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, 6525 GC, Netherlands

Location

Related Publications (6)

  • 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.

    PMID: 10965637BACKGROUND
  • 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.

    PMID: 14756612BACKGROUND
  • 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.

    PMID: 19249017BACKGROUND
  • 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.

    PMID: 16797486BACKGROUND
  • 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.

    PMID: 17535594BACKGROUND
  • 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.

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Anne E.M. Speckens
Organization
Radboud University Medical Centre

Study Officials

  • Anne EM Speckens, Prof. dr.

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anne E.M. Speckens, Prof. dr.

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 24, 2009

Study Start

January 1, 2005

Primary Completion

March 1, 2010

Study Completion

January 1, 2011

Last Updated

January 30, 2024

Results First Posted

January 30, 2024

Record last verified: 2024-01

Locations