Depressive Disorder, Major
Conditions
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
Mindfulness Based Cognitive Therapy is an 8-week during group intervention encompassing meditation practice and cognitive therapy techniques.
Therapeutic dose of antidepressant medication
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Relapse/recurrence of Major Depressive Episode | 3, 6, 9, 12, 15 months | Relapse or recurrence of depression will be assessed trimonthly using the Structured Clinical Interview for DSM-V (SCID) depression module. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Costs made by consumption of medical care and production loss | 3, 6, 9, 12, 15 months | 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. |
Countries
Netherlands