The treatment of depressive disorders with online psychological treatment supported by a clinician

Depression is a common mental disorder that has a high 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. brief

psychological treatments) are recommended before starting antidepressants. However the

dissemination 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 compared to the intention to start an antidepressant. The e-prescription will be a

prescription to an online self-management program based on the principles of behavioral

activation blended with a few face-to- face or telephonic contacts with a GP or POH-GGZ

(mental health worker of the general practice).

Objective:


The primary objective is to evaluate if a blended behavioral activation intervention reduces

depressive symptoms on the short term. Secondary objectives are to assess this additional

value on long term outcomes, and to assess its effectiveness on percentage response,

remission, treatment satisfaction, general health status, functional impairment and daily

activities.


The second aim of this study is to examine the real-time experience of cognitions, emotions as

well as behaviors during treatment by ecological momentary assessment (EMA). Compared to

more conventional questionnaires, EMA has the advantage to reduce memory distortions. It

also gives insight into actual experiences during treatment.



Study design

Pragmatic investigator blinded monocenter 1:1 randomized controlled trial



Study population:

Adult participants with a depressive disorder or depressive symptoms.



Intervention:

E-prescription of an online self-management program (one module per week spread over 5-10

weeks), blended with a few face-to- face or telephonic contacts with the GP or POH-GGZ.

Main study parameters/endpoints:

The main endpoint is the reduction in depressive symptoms as assessed by the Hamilton

Depression Rating Scale-17 (HRSD-17) from baseline to three months after intervention.

Secondary endpoints are the reduction on depressive symptoms using the HRSD-17 at 12

months, percentage response (50% reduction in symptoms on HRSD-17), remission (HRSD-

17 score below 7) at three and twelve months of follow-up, antidepressant use, effect on

general health status, treatment satisfaction, functional impairment and daily activities as well

as cost-effectiveness.


In addition to conventional questionnaires, we will capture real-time momentary ratings of

cognitions and moods with so-called Ecological Momentary Assessment (EMA) in a sub-

group of 60 participants. Specifically, using a smart phone application, auditory cue signals

will be sent to participants’ mobile smartphones. Thereupon, participants will be asked to rate

their momentary states of mood and distress, positive and negative affect as well as activity

levels. Momentary states will be rated on visual analogue scales.

The main aim is to evaluate the effectiveness of a blended behavioral activation intervention

or the offering of psychological care using an e-health program blended with support offered

by the mental health worker of the general practice (in Dutch POH-GGz). In a randomized

controlled trial, we will examine whether such blended treatment has additional value

compared to care as usual which frequently constitutes antidepressants alone.

Baseline, three months, six months and twelve months

Intervention:

The intervention under study is a prescription to an online self-management program blended with a few direct contacts (face-to-face or telephonic) with a GP or POH-GGZ. This program will focus on depressive symptoms and it will be based on the principles of behavioral activation. The program will consist of six to eight modules with a recommended frequency of 1-2 times a week over 6-10 weeks in well-structured sessions with GP at two, four and six weeks (or delegated to POH-GGZ). All participating GPs will receive training on the use of the e-prescription.



Comparator: Care as usual, with medical therapy or other as therapy.
Initiation of an antidepressant: the intention to start with antidepressant medication logically following the eligibility criteria. Consultations with GP will be arranged at two, four and six weeks (or delegated to POH-GGZ) and a prescription for antidepressant medication will be handed out. During the treatment the dose of the medication is allowed to be adjusted if necessary according to the GP.