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Blended care as a non-inferior alternative for usual care of depression
Keywords: depression blended care
Researchers: Prof. dr. P.F.M. Verhaak B. Massoudi
Type of project: Stage Wetenschap / Research project
Nature of the research: Non-inferiority trial among patients indicated for more intensive treatment of depressive symptoms
Fields of study: GP medicine psychiatry

Background / introduction

Guidelines recommend a stepped care approach for the treatment of depression in family practice . 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 a randomized controlled trial (Ph.D study of B.Massoudi) the effectiveness of blended care in the psychological treatment of depressed patients is tested. The blended care will be a prescription to an online self-management program based on the principles of behavioural activation guided with a few face-to-face or telephonic contacts with a POH-GGZ.

Research question / problem definition
What is the effectiveness of an online self-management program combined with direct contact (blended care) in the treatment of patients with a depressive disorder, dysthymic disorder or depressive symptoms for whom the general practitioner considers a more intensive treatment in terms of the three month reduction in severity of depressive symptoms compared to usual care?

Workplan

Design
The design of the study is a pragmatic investigator blinded 1:1 randomized controlled non-inferiority trial in general practice. After inclusion, there is a follow-up assessment at three months and at 12 months.

Inclusion
The population group will consist of adult patients presenting to the GP with a depressive disorder, dysthymic disorder or depressive symptoms for whom the GP considers a more intensive treatment. Eligibility for possible inclusion in this project is left at the discretion of the GP.
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 a more intensive treatment, which may include the prescription of an antidepressant..

Exclusion criteria assessed by the GP:
• 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 or e-mental health intervention)

Data collection

Baseline
Participants agreeing to participate will be asked to provide the following additional baseline data:
• Screening for depression and exclusion criteria using SCID (modules depression and anxiety disorder) (in the case that participants do not show depressive symptoms or meet the exclusion criteria they are excluded from the study).
• HRSD-17 to measure the severity of depression.
• Questionnaire on functional impairment and activity limitation using the self-report 12-item World Health Organization Disability Assessment Schedule (45).
• Questionnaire on general health status according to EQ-5D (43).

Follow-up assessments
During treatment:
First ten weeks:
• Weekly measurement of the severity of depression using the QIDS-SR 16 items.
• Momentary mood measurements (Ecological momentary assessments; EMA) are measurements in real time. Participants provide anxiety/mood ratings trough the means of a mobile smartphone with pre-installed EMA software. The EMA software will signal participants at random moments of the day to answer questions about emotion, affect and daily events. After an auditory signal, subjects fill out the self-assessment to record current context (activity, accompany and situation), and momentary mood states. Mood questions include both positive and negative affect items.

At 3 months:
• HRSD-17 to measure the severity of depression.
• Questionnaire on general health status according to EQ-5D (43).
• Questionnaire on functional impairment and activity limitation using the self-report 12-item World Health Organization Disability Assessment Schedule (45)
• Questionnaire on treatment satisfaction using the CSQ-8.

Outcome measures
Primary outcomes: reduction in symptoms of depression from baseline to the 3 months follow-up (as assessed blind to the intervention group by a trained interviewer using the Hamilton Depression Rating Scale – 17 (HRSD-17)).

Secondary outcomes: reduction in symptoms of depression from baseline to the 12 months follow-up (as assessed using the HRDS-17), 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, functional impairment, treatment satisfaction and cost-effectiveness.

Data analysis
To evaluate the effectiveness of the blended care compared to the usual care; the student will compare the two patient groups (N=20) regarding the repeated measurements of the depressive symptoms reported by the QIDS. To see whether the time to percentage response (50% reduction in symptoms on QIDS) and remission (QIDS score below 6) is different between the two groups, the student will do a survival analysis.

References

Van Weel-Baumgarten, Van Gelderen MG, Grundmeijer HGLM et al. NHG-standaard depressie (tweede herziening).. Huisarts Wet. 2012;55(6):252-9

Hermens ML, Muntingh A, Franx G, van Splunteren PT, Nuyen J. Stepped care for depression is easy to recommend, but harder to implement: Results of an explorative study within primary care in the netherlands. BMC Fam Pract. 2014 Jan 9;15:5,2296-15-5.

Bushnell J, McLeod D, Dowell A, Salmond C, Ramage S, Collings S, et al. The treatment of common mental health problems in general practice. Fam Pract. 2006 Feb;23(1):53-9.

Verhaak PF, van Dijk CE, Nuijen J, Verheij RA, Schellevis FG. Mental health care as delivered by dutch general practitioners between 2004 and 2008. Scand J Prim Health Care. 2012 Sep;30(3):156-62.

Ekers D, Webster L, Van Straten A, Cuijpers P, Richards D, Gilbody S. Behavioural activation for depression; an update of meta-analysis of effectiveness and sub group analysis. PLoS One. 2014 Jun 17;9(6):e100100.

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