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BACKGROUND: Insomnia is the transdiagnostically shared most common complaint in disorders of anxiety, stress and emotion regulation. Current cognitive behavioral therapies (CBT) for these disorders do not address sleep, while good sleep is essential for regulating emotions and learning new cognitions and behaviours: the core fundaments of CBT. This transdiagnostic randomized control trial (RCT) evaluates whether guided internet-delivered cognitive behavioral therapy for insomnia (iCBT-I) (1) improves sleep, (2) affects the progression of emotional distress and (3) enhances the effectiveness of regular treatment of people with clinically relevant symptoms of emotional disorders across all mental health care (MHC) echelons.METHODS: We aim for 576 completers with clinically relevant symptoms of insomnia as well as at least one of the dimensions of generalized anxiety disorder (GAD), social anxiety disorder (SAD), panic disorder (PD), posttraumatic stress disorder (PTSD) or borderline personality disorder (BPD). Participants are either pre-clinical, unattended, or referred to general- or specialized MHC. Using covariate-adaptive randomization, participants will be assigned to a 5 to 8-week iCBT-I (i-Sleep) or a control condition (sleep diary only) and assessed at baseline, and after two and eight months. The primary outcome is insomnia severity. Secondary outcomes address sleep, severity of mental health symptoms, daytime functioning, mental health protective lifestyles, well-being, and process evaluation measures. Analyses use linear mixed-effect regression models.DISCUSSION: This study can reveal for whom, and at which stage of disease progression, better nights could mean substantially better days.TRIAL REGISTRATION: International Clinical Trial Registry Platform (NL9776). Registered on 2021-10-07.

Borderline personality disorder (BPD) is a highly disabling psychiatric disorder with emotion dysregulation at its core, resulting in affective instability, impulsivity and sometimes self-harming or suicidal behavior. Sleep is increasingly recognized to play a crucial role in emotion regulation. BPD patients often suffer from (severe) insomnia, potentially aggravating symptoms and preventing recovery from BPD. Yet, the effects of insomnia treatments have not been investigated in context of BPD. Guided internet-based cognitive behavioral therapy for insomnia (iCBT-I; i-Sleep) has been proven effective in improving both insomnia and affective symptoms. In this randomized controlled trial among 96 patients with a DSM-5 diagnosis of BPD (or other personality disorder with ≥4 BPD traits) and insomnia symptoms, we will test the effectiveness of iCBT-I before regular BPD treatment starts, during the waitlist period, on BPD symptoms. Patients in the control group monitor their sleep through a sleep diary during the waitlist period and also receive standard BPD treatment after that. Using linear mixed models we will test the hypothesis that the iCBT-I group improves more than the control group on BPD symptoms (primary outcome), insomnia severity, additional subjective and objective sleep variables, emotion regulation, comorbid anxiety and depression complaints, and quality of life. These effects are thought to arise from a direct effect of improved sleep on emotion regulation and a synergistic effect on the consolidation and internalization of the BPD treatment effect. To our knowledge, this is the first trial assessing effectiveness of CBT-I in patients with BPD (traits). The accessibility of the studied intervention greatly facilitates clinical implication in case of positive results.