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Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Mindfulness Based Cognitive Therapy
Optimal Medical Care
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Recurrent Major Depressive Disorder, Mindfulness Based Cognitive Therapy, Cost-effectiveness, Antidepressant medication, Randomized Controlled Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Recurrent Major Depressive Episode (at least 3 previous episodes)
  • Treatment with therapeutic dose of antidepressant medication during past six months
  • Currently in full or partial remission

Exclusion Criteria:

  • Bipolar disorder (current and previous (hypo)manic episodes)
  • Psychotic disorder (current and previous)
  • Neurological or somatic illness affecting depression or outcome measures
  • Current alcohol or drugs dependency
  • Use of high dosage benzodiazepines (> 2 mg Lorazepam equivalents daily)
  • Recent Electro Convulsive Therapy (< 3 months ago)

Sites / Locations

  • Pro Persona
  • Pro Persona
  • Radboud University Nijmegen Medical Center
  • Pro Persona
  • GGZ Noord-Holland-Noord
  • Free University Medical Center and GGZ In Geest
  • AMC Amsterdam
  • GGZ Centraal
  • GGZ Rivierduinen - Leiden
  • Leiden University Medical Center
  • PsyQ
  • Parnassia ACO Zuid
  • GGZ Duin- en Bollenstreek

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Mindfulness Based Cognitive Therapy

Combination

Optimal Medical Care

Arm Description

Mindfulness Based Cognitive Therapy and withdrawal of antidepressant medication between the 4th and 5th session, patients being off medication until the end of study period (15 months).

Mindfulness Based Cognitive Therapy combined with the use of antidepressant medication during the study (15 months).

Treatment with optimal medical care: therapeutic dose of antidepressant medication during at least 15 months, administered in accordance with current guidelines.

Outcomes

Primary Outcome Measures

Relapse/recurrence of Major Depressive Episode
Relapse or recurrence of depression will be assessed trimonthly using the Structured Clinical Interview for DSM-V (SCID) depression module.

Secondary Outcome Measures

Costs made by consumption of medical care and production loss
Using prospective calendars and retrospective questionnaires about contacts with health care in the past 3 months (assessed trimonthly) we will estimate the costs of depression health care and the quality of life (selfreport). We will compare the cost-effectiveness ratios between the groups.

Full Information

First Posted
June 25, 2009
Last Updated
November 12, 2020
Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00928980
Brief Title
Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression
Official Title
The Clinical and Cost-effectiveness of Mindfulness Based Cognitive Therapy, Maintenance Antidepressant Medication and Its Combination in the Prevention of Relapse in Patients With Recurrent Depression
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the (cost)effectiveness of mindfulness based cognitive therapy (MBCT) compared to that of antidepressant medication, and its combination with regard to the prevention of relapse or recurrence in patients with recurrent depression.
Detailed Description
In the Netherlands, treatment as usual for patients with (recurrent) Major Depressive Disorder consists of maintenance antidepressant medication. Mindfulness-based cognitive therapy (MBCT) is a recently developed psychological intervention that appears to be promising in terms of preventing relapse or recurrence in patients with recurrent depression. It consists of 8 weekly group sessions in which meditation exercises are combined with cognitive therapeutic elements such as identifying negative thoughts and monitoring and scheduling activities. In this study, the (cost)effectiveness of a) MBCT on its own, b) antidepressant medication on its own and c) the combination of MBCT and antidepressant medication will be investigated in 350 patients with recurrent depression who are currently in remission.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Recurrent Major Depressive Disorder, Mindfulness Based Cognitive Therapy, Cost-effectiveness, Antidepressant medication, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
317 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Based Cognitive Therapy
Arm Type
Experimental
Arm Description
Mindfulness Based Cognitive Therapy and withdrawal of antidepressant medication between the 4th and 5th session, patients being off medication until the end of study period (15 months).
Arm Title
Combination
Arm Type
Experimental
Arm Description
Mindfulness Based Cognitive Therapy combined with the use of antidepressant medication during the study (15 months).
Arm Title
Optimal Medical Care
Arm Type
Active Comparator
Arm Description
Treatment with optimal medical care: therapeutic dose of antidepressant medication during at least 15 months, administered in accordance with current guidelines.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Cognitive Therapy
Intervention Description
Mindfulness Based Cognitive Therapy is an 8-week during group intervention encompassing meditation practice and cognitive therapy techniques.
Intervention Type
Drug
Intervention Name(s)
Optimal Medical Care
Intervention Description
Therapeutic dose of antidepressant medication
Primary Outcome Measure Information:
Title
Relapse/recurrence of Major Depressive Episode
Description
Relapse or recurrence of depression will be assessed trimonthly using the Structured Clinical Interview for DSM-V (SCID) depression module.
Time Frame
3, 6, 9, 12, 15 months
Secondary Outcome Measure Information:
Title
Costs made by consumption of medical care and production loss
Description
Using prospective calendars and retrospective questionnaires about contacts with health care in the past 3 months (assessed trimonthly) we will estimate the costs of depression health care and the quality of life (selfreport). We will compare the cost-effectiveness ratios between the groups.
Time Frame
3, 6, 9, 12, 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Recurrent Major Depressive Episode (at least 3 previous episodes) Treatment with therapeutic dose of antidepressant medication during past six months Currently in full or partial remission Exclusion Criteria: Bipolar disorder (current and previous (hypo)manic episodes) Psychotic disorder (current and previous) Neurological or somatic illness affecting depression or outcome measures Current alcohol or drugs dependency Use of high dosage benzodiazepines (> 2 mg Lorazepam equivalents daily) Recent Electro Convulsive Therapy (< 3 months ago)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne EM Speckens, Prof. dr.
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pro Persona
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6800
Country
Netherlands
Facility Name
Pro Persona
City
Ede
State/Province
Gelderland
Country
Netherlands
Facility Name
Radboud University Nijmegen Medical Center
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GC
Country
Netherlands
Facility Name
Pro Persona
City
Tiel
State/Province
Gelderland
Country
Netherlands
Facility Name
GGZ Noord-Holland-Noord
City
Alkmaar
State/Province
Noord-Holland
Country
Netherlands
Facility Name
Free University Medical Center and GGZ In Geest
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1000
Country
Netherlands
Facility Name
AMC Amsterdam
City
Amsterdam
State/Province
North Holland
ZIP/Postal Code
1100 DD
Country
Netherlands
Facility Name
GGZ Centraal
City
Amersfoort
State/Province
Utrecht
ZIP/Postal Code
3800
Country
Netherlands
Facility Name
GGZ Rivierduinen - Leiden
City
Leiden
State/Province
Zuid Holland
ZIP/Postal Code
2300 AT
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
Zuid Holland
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
PsyQ
City
Den Haag
State/Province
Zuid-Holland
ZIP/Postal Code
2500
Country
Netherlands
Facility Name
Parnassia ACO Zuid
City
Den Haag
State/Province
Zuid-Holland
Country
Netherlands
Facility Name
GGZ Duin- en Bollenstreek
City
Katwijk
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
19045965
Citation
Kuyken W, Byford S, Taylor RS, Watkins E, Holden E, White K, Barrett B, Byng R, Evans A, Mullan E, Teasdale JD. Mindfulness-based cognitive therapy to prevent relapse in recurrent depression. J Consult Clin Psychol. 2008 Dec;76(6):966-78. doi: 10.1037/a0013786.
Results Reference
background
PubMed Identifier
14756612
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.
Results Reference
background
PubMed Identifier
10965637
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.
Results Reference
background
PubMed Identifier
33177138
Citation
Huijbers MJ, Wentink C, Simons E, Spijker J, Speckens A. Discontinuing antidepressant medication after mindfulness-based cognitive therapy: a mixed-methods study exploring predictors and outcomes of different discontinuation trajectories, and its facilitators and barriers. BMJ Open. 2020 Nov 11;10(11):e039053. doi: 10.1136/bmjopen-2020-039053.
Results Reference
derived
PubMed Identifier
26892847
Citation
Huijbers MJ, Spinhoven P, Spijker J, Ruhe HG, van Schaik DJ, van Oppen P, Nolen WA, Ormel J, Kuyken W, van der Wilt GJ, Blom MB, Schene AH, Rogier A, Donders T, Speckens AE. Discontinuation of antidepressant medication after mindfulness-based cognitive therapy for recurrent depression: randomised controlled non-inferiority trial. Br J Psychiatry. 2016 Apr;208(4):366-73. doi: 10.1192/bjp.bp.115.168971. Epub 2016 Feb 18.
Results Reference
derived
PubMed Identifier
26318271
Citation
Huijbers MJ, Spinhoven P, Spijker J, Ruhe HG, van Schaik DJ, van Oppen P, Nolen WA, Ormel J, Kuyken W, van der Wilt GJ, Blom MB, Schene AH, Donders AR, Speckens AE. Adding mindfulness-based cognitive therapy to maintenance antidepressant medication for prevention of relapse/recurrence in major depressive disorder: Randomised controlled trial. J Affect Disord. 2015 Nov 15;187:54-61. doi: 10.1016/j.jad.2015.08.023. Epub 2015 Aug 18.
Results Reference
derived
PubMed Identifier
22925198
Citation
Huijbers MJ, Spijker J, Donders AR, van Schaik DJ, van Oppen P, Ruhe HG, Blom MB, Nolen WA, Ormel J, van der Wilt GJ, Kuyken W, Spinhoven P, Speckens AE. Preventing relapse in recurrent depression using mindfulness-based cognitive therapy, antidepressant medication or the combination: trial design and protocol of the MOMENT study. BMC Psychiatry. 2012 Aug 27;12:125. doi: 10.1186/1471-244X-12-125.
Results Reference
derived

Learn more about this trial

Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression

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