BLENDING: BLENded care for Depressive symptoms IN General practice: a randomised non-inferiority trial

Rationale: Depression is a common mental disorder that has a high burden of
disease and high economic burden. The majority of patients with mental health
problems are treated by general practitioners (GPs). Guidelines recommend a
stepped care approach for the treatment of these patients. This means that
structured non-pharmacological interventions of low-intensity (e.g. short
psychological treatments) are recommended before starting antidepressants.
However the use of this approach is limited and it has been estimated that 70%
of the cases are primarily treated with antidepressants. Time constraints and
lack of familiarity with psychological treatments are probably key to this
problem. In this randomized controlled trial we will study the effectiveness of
an e-prescription for a blended care approach in the psychological treatment of
participants with depression or depressive symptoms in the general practice.
The e-prescription will be a prescription to an online self-management program
based on the principles of behavioural activation and problem-solving
treatment, blended with a few telephonic or face-to-face contacts with a GP or
POH-GGZ.

Objective:
Primary objective is to demonstrate non-inferiority of the e-prescription to
the use of antidepressants on the short term. Secondary objectives are to
assess its effect on long term outcomes, antidepressant use, and to assess its
effectiveness on percentage response, remission, functional impairment,
treatment satisfaction and general health status.

Study design: Pragmatic investigator blinded monocentre 1:1 randomized
controlled non-inferiority trial

Intervention:
E-prescription to an online self-management program (1-2 sessions per week
spread over 5-10 weeks), blended with a few telephonic or face-to-face contacts
with the GP or POH-GGZ.

There are minimal risks associated with this trial, as the intervention is
non-invasive. A potential but likely neglegible risk is violation of privacy.
However the e-prescription will be designed to be as non-intrusive and secure
as possible according to the quality criteria of the NEN7510.

Major depressive disorder comes with a risk of suicide. This is intrinsic to
this disorder and not related to the intervention. In this study we will
monitor depressive symptoms en suicidality during the intervention (as
previously mentioned). See also the protocol pages 28 and 32.

There is some degree of burden; participants will follow their e-prescription
or prescription of antidepressants. They will be interviewed four times during
this study, during the inclusion, at baseline and also after three and twelve
months follow-up by the researcher or the research assistant. At baseline and
at follow-up questionnaires will be administrated through the internet. These
research data will be coded. During the intervention there will be three
consultations with their GP in either group to discuss any problems occurring
in the course of treatment in both groups. Participants will receive reminders
through e-mail to fill in questionnaires for the monitoring. The estimated time
investment is around 10 hours in one year for patients who have been randomized
to the e-prescription. This includes two hours for filling in questionnaires
and two hours for participating in the interviews.