Internet-guided cognitive, behavioral and chronobiological interventions in depression-prone insomnia subtypes: protocol of a randomized controlled prevention trial

Abstract

Background: Major depressive disorder is among the most burdening and costly chronic health hazards. Since its prognosis is poor and treatment effectiveness is moderate at best, prevention would be the strategy of first choice. Insomnia may be the best modifiable risk factor. Insomnia is highly prevalent (4-10%) and meta-analysis estimates ±13% of people with insomnia to develop depression within a year. Among people with insomnia, recent work identified three subtypes with a particularly high lifetime risk of depression. The current randomized controlled trial (RCT) evaluates the effects of internet-guided Cognitive Behavioral Therapy for Insomnia (CBT-I), Chronobiological Therapy (CT), and their combination on insomnia and the development of depressive symptoms. Methods:We aim to include 120 participants with Insomnia Disorder (ID) of one of the three subtypes that are more prone to develop depression. In a two by two factorial repeated measures design, participants will be randomized to CBT-I, CT, CBT-I + CT or treatment as usual, and followed up for one year. The primary outcome is the change, relative to baseline, of the severity of depressive symptoms integrated over four follow-ups spanning one year. Secondary outcome measures include a diagnosis of major depressive disorder, insomnia severity, sleep diaries, actigraphy, cost-effectiveness, and brain structure and function.(Continued on next page)

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

“…Future studies could increase sensitivity by extending the follow-up period to multiple years. A limitation with respect to the interpretation of our findings on adherence and dropout is that this RCT was part of a larger multimodal investigation [23]. This embedding may have contributed to the adherence of the participants.…”

“…Other exclusion criteria were: (b) current treatment with antidepressant medication; (c) current CBT-I treatment; (d) a severe sleep disorder other than insomnia (i.e., sleep apnea, restless legs syndrome, periodic limb movement disorder); (e) a current diagnosis of any other severe neurological or psychiatric disorder; and (f) night work or rotating shift-work. See Leerssen et al [23] for more details.…”

“…The study protocol of this randomized controlled trial (RCT) has been previously published [23]. In brief, high-risk insomniacs were randomized to one of four groups: no treatment (NT, passive control), or 6 weeks of digital therapist-guided CRS (active control), CBT-I, or combined CBT-I+CRS.…”

“…Assessment of outcome measures (see below) took place at baseline (T0) and during four follow-up assessments at week 7 (T1), week 26 (T2), week 39 (T3), and week 52 (T4). This RCT was part of a larger multimodal investigation including, for example, sleep EEG, MRI, and ambulatory monitoring [23]. Online supplementary Table S2 provides a checklist for methodological recommendations for clinical trials according to Guidi et al [24].…”

“…Dropout and loss to follow-up were less than expected, resulting in 124 participants that fully completed the interventions, and 120 participants that completed each of the five assessments. See the study protocol for more details [23].…”