Effectiveness and cost-effectiveness of internet-based treatment of insomnia in depressed patients treated at a mental healthcare outpatient clinic.

Patients with unipolar depression often simultaneously meet the DSM-5 criteria for insomnia disorder. These patients have significantly lower quality of life and worse treatment outcomes than depressive patients without insomnia. While cognitive behavioral therapy for insomnia (CBT-I) is the treatment option of first choice, insomnia is currently, if recognized accurately, often treated pharmacologically. A pilot study has already shown that the online CBT-I intervention i-Sleep could potentially serve as a relatively easily accessible addition to the usual care for depression. However, a randomized controlled trial evaluating the effectiveness and cost-effectiveness of adding i-Sleep to usual care among depressed patients has not yet been performed. The current project aims to assess both the effectiveness and cost-effectiveness of an internet-based insomnia intervention (i-Sleep) prior to usual care for depression, compared to usual care alone, in depressive patients with comorbid insomnia treated at a specialized mental healthcare outpatient clinic. Furthermore, a process evaluation of implementing i-Sleep in daily clinical practice will take place.

We hypothesize that addition of i-Sleep to usual care for depression improves patient outcomes and reduces societal costs as compared to usual care alone.

Repeated assessments will take place at baseline (prior to the start of treatment) and at 3, 6, 9, and 12 months of follow-up.

A guided, internet-based cognitive behavioral therapy program for insomnia (i-Sleep). This online CBT-I program consists of five sessions, containing information and exercises on sleep.