Skip to content

Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00928980
Enrollment
317
Registered
2009-06-26
Start date
2009-05-31
Completion date
2013-06-30
Last updated
2020-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Major

Keywords

Recurrent Major Depressive Disorder, Mindfulness Based Cognitive Therapy, Cost-effectiveness, Antidepressant medication, Randomized Controlled Trial

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.

Interventions

BEHAVIORALMindfulness Based Cognitive Therapy

Mindfulness Based Cognitive Therapy is an 8-week during group intervention encompassing meditation practice and cognitive therapy techniques.

Therapeutic dose of antidepressant medication

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development
CollaboratorOTHER
Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Relapse/recurrence of Major Depressive Episode3, 6, 9, 12, 15 monthsRelapse or recurrence of depression will be assessed trimonthly using the Structured Clinical Interview for DSM-V (SCID) depression module.

Secondary

MeasureTime frameDescription
Costs made by consumption of medical care and production loss3, 6, 9, 12, 15 monthsUsing 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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026