Discontinuation of antidepressant medication in primary care whether or not supported by Mindfulness Based Cognitive Therapy (MBCT).

In the Netherlands antidepressants are the most commonly prescribed medication
with a total number of users in 2014 of 1.1 million people. After starting
antidepressant medication almost 30% of the patients become chronic users.
Current NHG-guidelines for primary care advise to discuss discontinuation of
antidepressants six months after remission of a depression or 6-12 months after
remission of an anxiety disorder. Patients with recurrent depression are
advised to discontinue medication after 1-2 years. It is recommended to taper
slowly which is defined as a 50% dose reduction every two weeks while
monitoring side effects and relapse prevention. Stopping antidepressant
medication can be hampered by strong withdrawal effects, which are often
difficult to differentiate from early signals of a return of the symptoms of
the disorder for which the antidepressants had been described in the first
place. Unnecessary treatment can also be caused by anticipation fears of both
doctors and patients due to former discontinuation attempts that were
unsuccessful. Dutch organizations of depressive and anxious patients such as DV
and ADFS notice the need for more guidance in tapering antidepressant
medication but are not able to offer their members a clear strategy either.
Considering the fact that a substantial number of patients prefer not to use
antidepressant medication given their experience of limited effectiveness and
side-effects, there seems to be a need to support them and their attending
physicians better in discontinuing it.

A first aim of this study is to co-create three types of information material
that support the tapering of antidepressant medication: patient documentation,
a shared-decision-aid and a discontinuation protocol.
A second aim of this study is to investigate the effectiveness of the
combination of a supported protocolized discontinuation (SPD, which includes
the decision aid and the discontinuation protocol) and mindfulness-based
cognitive therapy (MBCT) in comparison with SPD only in increasing the
proportion of patients successfully discontinuing their long-term use of
antidepressants in primary care. Secondary outcome measures will be
discontinuation effects, symptoms of depression and anxiety, quality of life
and medical and societal costs.

The study consists of two phases.
-Phase 1: Development of materials
Patient documentation, a shared-decision-aid for GPs and a discontinuation
protocol.
-Phase 2: Cluster-randomized controlled trial
Patients in primary care using antidepressant medication for more than 9 months
will be identified in the electronic prescription system. General practices
will be randomly allocated to either Supported Protocolized Discontinuation
(SPD) or SPD + Mindfulness Based Cognitive Therapy (MBCT). Patients
discontinuing their antidepressant medication are requested to discontinue
within 6 months at most. Follow-up assessments take place 6, 9 and 15 months
after baseline.

General practices offer either SPD or SPD+MBCT
-Supported Protocolized Discontinuation (SPD)
Patient and GP make a shared decision whether to continue of discontinue the
antidepressant medication. Those choosing to discontinue will be offered
additional meetings with their POH-GGZ to support the discontinuation process.
-SPD + Mindfulness based cognitive therapy (MBCT)
The MBCT is in addition to the SPD. The MBCT-program will be tailored to the
needs of patients discontinuing their antidepressant medication. The
psycho-educational sections about depression will be accommodated with
psycho-education about anxiety, withdrawal effects and pro and cons of stopping
antidepressants.

Burden:
-GPs will be asked to identify patients using antidepressant medication for
more than 9 months out of their electronic system (HIS) and to invite them to
participate in the study. With patients willing to participate they will have a
double consultation where the decision aid will be discussed and if applicable
a personal taperingschedule will be made.
-The POH-GGZ will be asked to have a minimum of 3 meetings with each patient
attending the study to guide and monitor the taperingprocess and follow up.
-Patients participating in the process with SPD will have a double consultation
(20 minutes) with their GP to discuss the decision aid and decide whether or
not to discontinue. If they discontinue a personal taperingschedule is
discussed. After this they will have a minimum of 3 meetings with the POH-GGZ
to guide and monitor the taperingprocess and follow up.
-Patients participating in the process with MBCT+SPD will have an additional
MBCT training consisting of eight 2,5 hours sessions every two weeks and one
silent day of 6 hours
Risk:
Patients may experience withdrawal effects.
Patients may experience a relapse in depression or anxiety.