Treating Insomnia with High Risk of Depression Using Therapist-Guided Digital Cognitive, Behavioral, and Circadian Rhythm Support Interventions to Prevent Worsening of Depressive Symptoms: A Randomized Controlled Trial

Abstract

<b><i>Introduction:</i></b> The global disease burden of major depressive disorder urgently requires prevention in high-risk individuals, such as recently discovered insomnia subtypes. Previous studies targeting insomnia with fully automated eHealth interventions to prevent depression are inconclusive: dropout was high and likely biased, and depressive symptoms in untreated participants on average improved rather than worsened. <b><i>Objective:</i></b> This randomized controlled trial aimed to efficiently prevent the worsening of depressive symptoms by selecting insomnia subtypes at high risk of depression for internet-based circadian rhythm support (CRS), cognitive behavioral therapy for insomnia (CBT-I), or their combination (CBT-I+CRS), with online therapist guidance to promote adherence. <b><i>Methods:</i></b> Participants with an insomnia disorder subtype conveying an increased risk of depression (<i>n</i> = 132) were randomized to no treatment (NT), CRS, CBT-I, or CBT-I+CRS. The Inventory of Depressive Symptomatology – Self Report (IDS-SR) was self-administered at baseline and at four follow-ups spanning 1 year. <b><i>Results:</i></b> Without treatment, depressive symptoms indeed worsened (<i>d</i> = 0.28, <i>p</i> = 0.041) in high-risk insomnia, but not in a reference group with low-risk insomnia. Therapist-guided CBT-I and CBT-I+CRS reduced IDS-SR ratings across all follow-up assessments (respectively, <i>d</i> = –0.80, <i>p</i> = 0.001; <i>d</i> = –0.95, <i>p</i> < 0.001). Only CBT-I+CRS reduced the 1-year incidence of clinically meaningful worsening (<i>p</i> = 0.002). Dropout during therapist-guided interventions was very low (8%) compared to previous automated interventions (57–62%). <b><i>Conclusions:</i></b> The findings tentatively suggest that the efficiency of population-wide preventive strategies could benefit from the possibility to select insomnia subtypes at high risk of developing depression for therapist-guided digital CBT-I+CRS. This treatment may provide effective long-term prevention of worsening of depressive symptoms. <b><i>Trial registration:</i></b> the Netherlands Trial Register (NL7359).

Combining cardiac monitoring with actigraphy aids nocturnal arousal detection during ambulatory sleep assessment in insomnia

“…Participants with insomnia and controls without sleep complaints were recruited through the Netherlands Sleep Registry ( www.slaapregister.nl ), advertisements, and media to join a longitudinal study on insomnia [ 18 ]. We only considered applicants between 18 and 70 years of age.…”

“…After application, we verified by phone that participants met the inclusion criteria and insomnia criteria when applicable. Exclusion criteria for both participants with insomnia and controls relevant for the current analyses were: a current diagnosis of (1) current major depressive disorder, (2) current treatment with antidepressant medication, (3) current CBT-I treatment, (4) sleep apnea syndrome, moderate to severe restless legs syndrome or severe periodic limb movement disorder, (5) self-reported diagnosis of a severe neurological or psychiatric disorder, (6) self-reported severe physical or mental impairment due to stroke, or traumatic head injury, (7) current shift work (but see [ 18 ] for a complete list of exclusion criteria). The use of sleep medication was permitted and monitored (see Supplementary Material and Supplementary Tables S1-S4 for detailed information on sleep medication monitoring and results of nonmedicated patients only).…”

“…Ambulatory recordings were part of a larger study [ 18 ] approved by the Medical Ethics Committee of the VU University Medical Centre (NL63139.029.17) and obtained only after participants had provided written informed consent. Participants received wearable sensors during their first lab visit with detailed instructions.…”

Insomnia disorder: State of the science and challenges for the future

“…One step further will address the primary prevention of mental disorders. There is a strong probability that adequate insomnia treatment will reduce the incidence and recurrence of depressive episodes and anxiety disorders (Benz et al, 2020; Cheng et al, 2019; Irwin et al, 2022; Leerssen et al, 2021). In a first step, one might address risk groups especially prone to mental illness and offer sleep treatment versus a control condition and compare longitudinal outcomes, as recently demonstrated by Leerssen et al (2021).…”

Guided internet-based cognitive behavioral therapy for insomnia in patients with borderline personality disorder: Study protocol for a randomized controlled trial

“…Within our group we developed the guided online iCBT-I intervention called i-Sleep. This intervention was tested in four RCT's covering different populations with insomnia complaints, showing large effect sizes on self-reported quality of sleep, sleep-diary derived sleep continuity and secondary outcomes such as symptoms of depression ( van Straten et al, 2013 ; van der Zweerde et al, 2020 ; van der Zweerde et al, 2018 ; Leerssen et al, 2021 ). Adding CBT-I to standard treatment in patients suffering from BPD and insomnia complaints may be promising, not only to reduce sleep disturbances, but also to mitigate BPD symptoms.…”