|- candidate number||19352|
|- NTR Number||NTR4757|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-aug-2014|
|- Secondary IDs||NL80-83910-98-12010 |
|- Public Title||The treatment of depressive disorders with online psychological treatment supported by a clinician|
|- Scientific Title||BLENded care for Depressive symptoms IN General practice|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Depression, Depressive symptoms, Depressive disorders|
|- Inclusion criteria||In order to be eligible to participate in this study, a subject must meet all of the following criteria: |
- Adult patients, i.e. aged 18 or over;
- Patients presenting to the GP with depressive disorder or depressive symptoms;
- Patients for whom a GP considers prescribing an antidepressant.
|- Exclusion criteria||- Severe depression requiring referral to specialized mental health service according to current guideline, e.g. acute suicidality|
- Severe mental illness (current/past: schizophrenia, psychotic episode, bipolar disorder, depression with psychotic features)
• Anxiety disorder or obsessive compulsive disorder as primary diagnosis
- Current substance abuse (e.g. alcohol, drugs)
- Currently receiving treatment for depression (e.g. antidepressant medication, e-mental health intervention or psychological treatment)
- Insufficient command of the Dutch language
- No informed consent given
- No internet available or grossly insufficient computer skills
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2014|
|- planned closingdate||1-sep-2018|
|- Target number of participants||302|
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.
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.
|- Primary outcome||Reduction in symptoms of depression from baseline to the 3 months follow-up |
|- Secondary outcome||1. Long-term outcome: reduction in symptoms of depression from baseline to 12 month follow-up |
2. Percentage response
3. Remission at 3 and 12 months follow-up
4. Antidepressant use: number of prescriptions and dosage
5. Use of other psychotropics (such as benzodiazepines): number of prescriptions and dosage
6. Change from baseline to 3 and 12 months follow-up in functional impairment and activity limitation using the self-report
7. Health care utilization including visits to health care professionals (e.g. GP, psychologist, occupational physician) and use of the intervention and production loss
8. Change from baseline to 3 and 12 month follow-up in general health status
9. Treatment satisfaction to measure the user friendliness of the intervention.
|- Timepoints||Baseline, three months, six months and twelve months|
|- Trial web site||www.e-recept.nl|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. H. Burger|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. H. Burger|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||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).|
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
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.
Pragmatic investigator blinded monocenter 1:1 randomized controlled trial
Adult participants with a depressive disorder or depressive symptoms.
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
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.
|- Main changes (audit trail)||12-mrt-2015: MET goedkeuring verkregen-EB|
- Patients for whom a GP wants to intensify the current therapy with medications, psychological therapy (GGz) or other
Care as usual, with medical therapy or other as therapy.
“Patients for whom a GP considers prescribing an antidepressant”
with depressive symptoms or a depressive disorder for whom the GP or general practice
mental health worker consider a second step in the treatment of depression after the first step
of psycho-education and day-structuring exercises have yielded insufficient improvement.”
“Currently receiving treatment for depression (e.g. antidepressant medication, e-
mental health intervention or psychological treatment)”
psychological treatment for depression (e-mental health intervention or face-to- face
Secondary outcome NEW:
10. Ecological Momentary Assessment (EMA) or real-time ratings of momentary states of
cognitions and moods every other day, 5 times per day at random moments, over the course of
a 10-week period.
|- RECORD||25-aug-2014 - 29-apr-2017|