Internet-delivered cognitive behavioural therapy for insomnia disorder in depressed patients treated at an outpatient clinic for mood disorders: protocol of a randomised controlled trial

A Y Schotanus, E Dozeman, S L C Ikelaar, A van Straten, A T F Beekman, F van Nassau, J E Bosmans, A van Schaik

Research output: Contribution to JournalArticleAcademic


BACKGROUND: Major depression is a highly prevalent disorder causing severe personal distress, and high societal costs. Patients with depression often have comorbid insomnia disorder (ID) leading to even worse personal distress and worse treatment outcomes. Recent results from a non-randomised pilot study with internet-delivered Cognitive Behavioural Therapy (CBTi) for Insomnia (I-Sleep) added to regular depression care were promising regarding feasibility and initial effects on insomnia complaints and depression. However, no randomised controlled trial (RCT) has been performed yet to access the (cost-) effectiveness of I-Sleep for depression. Therefore, this protocol article presents the design of an RCT aimed to assess the (cost-) effectiveness of I-Sleep in addition to usual care for depression compared to usual care alone in depressed patients with a comorbid Insomnia Disorder (ID) treated at outpatient clinics for mood disorders. METHODS /DESIGN: This is a multi-centre RCT with measurements at baseline and at 3, 6, 9, and 12 months of follow-up. Patients with depression and an ID are randomised to either I-Sleep treatment followed by regular depression care or to regular depression care alone. Our aim is to recruit one hundred and seventy-five patients from multiple outpatient clinics for mood disorders. The primary outcome is the change in depressive symptoms over 12 months of follow-up measured with the Patient Health Questionnaire (PHQ-9). Secondary outcomes are recovery from depression (PHQ-9), insomnia severity (Insomnia Severity Index, ISI), daily functioning (Work and Social Adjustment Scale, WSAS), general quality of life (EuroQol 5-level version, EQ-5D-5L), and societal costs (Adapted versions of the iMTA Productivity Cost Questionnaire, iPCQ and iMTA Medical Cost Questionnaire, iMCQ).

DISCUSSION: We hypothesize that the addition of I-Sleep to usual care will result in a significant improvement in depression treatment outcomes and quality of life as well as a decrease in healthcare and societal costs compared to usual care alone. This study is the first pragmatic RCT evaluating the effectiveness and cost-effectiveness of adding CBTi to usual care for depression.

TRIAL REGISTRATION: Netherlands Trial Register (NL8955). Registered on October 6 th2020.

Original languageEnglish
Article number75
Pages (from-to)75
JournalBMC Psychiatry
Issue number1
Publication statusPublished - 27 Jan 2023

Bibliographical note

© 2023. The Author(s).


The EINSTEIN study is funded by ZonMw (grant/project number 852002025) consequently the study protocol has undergone full external peer review by ZonMw as part of the peer review process. However, the EINSTEIN study is an investigator-initiated study with Amsterdam UMC, location VUmc as the study sponsor. Therefore, the study funder has had no role in the design of the study, the collection, analysis and interpretation of the data, or in the preparation, review or approval of the manuscript. We would like to thank Amsterdam Public Health VU and all participating outpatient mental health clinics for their cooperation, advice and contributions to this study. Additionally, we would like to express our gratitude to all participating patients with depression and insomnia disorder, without whom this study wouldn’t have been possible. We originally intended to recruit 175 participants from four mental health clinics. However, due to restraints caused by the ongoing Covid-19 pandemic and subsequent raised pressure on mental health care institutions, current inclusion numbers are lagging expectations. Therefore, we’re expanding the scope of this trial and are planning to include participants from other, additional mental health clinics.

FundersFunder number
Amsterdam Public Health VU


    • Humans
    • Ambulatory Care Facilities
    • Cognitive Behavioral Therapy/methods
    • Depressive Disorder, Major/complications
    • Quality of Life
    • Randomized Controlled Trials as Topic
    • Sleep Initiation and Maintenance Disorders/complications
    • Treatment Outcome
    • Internet-Based Intervention


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