CBT-I Moves Into Psychosis Care in a Finnish Randomized Trial
Insomnia sits close to the center of daily morbidity in schizophrenia and schizoaffective disorder, yet it often remains treated as a secondary complaint rather than a therapeutic target in its own right. This ongoing randomized controlled trial is testing whether cognitive behavioural therapy for insomnia can improve sleep and quality of life when delivered either individually through the internet or in a group format on a virtual platform, both alongside treatment as usual.
The protocol reflects a simple but consequential clinical question: if sleep is stabilized, does the broader burden of psychosis become easier to carry? Sleep disruption can intensify subjective distress, worsen functioning, and erode well-being, and the study is built around the idea that insomnia deserves direct treatment rather than passive observation inside routine psychiatric care.
Three-Arm Design Brings Sleep Treatment Into Routine Psychosis Services
Recruitment is planned from the Psychosis Clinics of Helsinki University Hospital and the City of Helsinki Health Services, with an intended sample of 84 to 120 outpatients. Eligibility is anchored in two straightforward criteria: a diagnosis of schizophrenia or schizoaffective disorder and self-reported sleep problems. The investigators will run the study in cycles, each enrolling 12 to 24 participants, a structure that suits a behavioral intervention delivered across a clinical service rather than a single tightly contained ward setting.
Participants are randomized to one of three arms: treatment as usual alone, internet-based individual CBT-I plus treatment as usual, or group CBT-I delivered via a virtual platform plus treatment as usual. The comparator is clinically sensible because it mirrors the baseline care that patients would otherwise receive, making any added benefit of targeted insomnia treatment easier to interpret in practice.
One sentence captures the trial’s central wager: sleep can be treated directly even when psychosis is present.
Outcomes Extend Beyond Sleep Latency and Nighttime Awakenings
The primary endpoints are quantitative change in the Insomnia Severity Index and/or change in health-related quality of life measured with the 15D instrument. Both measures matter because insomnia in this population is not merely a nighttime phenomenon; it spills into daytime cognition, emotional regulation, motivation, and social participation. A reduction in insomnia symptoms without a corresponding gain in quality of life would be less persuasive clinically than a broader shift in patient-reported functioning.
Secondary outcomes widen the lens to self-reported sleep, health, stress, and the severity of psychotic and depressive symptoms. That scope matters because insomnia may sit upstream of symptom amplification, and the protocol is designed to examine whether a sleep intervention can move more than one clinical domain at once. In psychotic disorders, fragmented sleep can complicate affective stability and may make routine psychiatric symptoms feel less controllable to patients, even when antipsychotic treatment is unchanged.
Objective monitoring is also built into the design. Actigraphy and bed sensor data will be used to evaluate circadian rhythms and motor activity, adding a physiological layer to the self-report outcomes. Those tools are especially relevant in schizophrenia, where sleep-wake dysregulation may reflect altered circadian timing, irregular daily structure, and reduced daytime activity. By pairing subjective and objective measures, the study is positioned to detect whether perceived improvement corresponds to measurable changes in nocturnal rest and movement patterns.
Internet Delivery and Group Format Test Two Different Paths to Access
The intervention model is clinically practical. Internet-based individual therapy may reduce access barriers for patients who struggle with travel, scheduling, social anxiety, or service fragmentation. Group CBT-I delivered virtually could offer peer contact and shared structure while preserving the core behavioral components of insomnia treatment. In psychosis care, where adherence to repeated appointments can be difficult, the choice of digital delivery is not cosmetic; it is a direct response to real-world service constraints.
CBT-I remains the recommended first-line treatment for insomnia in general practice, and this protocol extends that standard into a population that has historically been underrepresented in behavioral sleep research. Only a few randomized trials have previously examined CBT-I in schizophrenia, leaving a narrow evidence base for clinicians who want to treat sleep without worsening psychotic symptoms or adding sedative burden. A carefully monitored trial is a reasonable way to test whether standard insomnia therapy can be adapted safely and effectively for this group.
The use of treatment as usual in all arms also keeps the study anchored to everyday psychiatric care. Patients will not be withdrawn from established mental health treatment in order to test sleep therapy in isolation, which makes the protocol easier to translate into routine practice if the findings prove favorable.
Twelve, Twenty-Four, and Thirty-Six Weeks Mark the Follow-Up Arc
Outcome assessments are scheduled at baseline and then after the treatment period at weeks 12, 24, and 36. That cadence allows the investigators to observe immediate response as well as whether any benefit persists after the active intervention phase. For insomnia treatment, durability matters. Patients with chronic psychotic disorders often live with long-standing sleep disruption, and transient gains are less useful than improvements that endure beyond the first burst of engagement.
The staged follow-up also offers a way to watch for delayed changes in mood, psychotic symptoms, stress, and functioning. Behavioral sleep therapy can take time to alter routines, cognitive arousal, and nocturnal habits, especially in a population with complex psychiatric needs. A shorter follow-up window would risk missing slower but clinically meaningful change.
Ethics Approval and Trial Registration Anchor the Protocol
The Coordinating Ethics Committee of the Hospital District of Helsinki and Uusimaa approved the protocol, and the study is registered under NCT04144231. Those formal steps matter because behavioral trials in serious mental illness require clear safeguards around consent, monitoring, and clinical oversight. The publication is a protocol rather than a results paper, so no efficacy or safety conclusions can be drawn yet.
What will matter most in the eventual readout is whether the sleep intervention produces a measurable improvement in insomnia severity, whether quality of life moves in parallel, and whether either delivery format proves more workable for patients with psychotic disorders. The protocol also leaves open a practical question for clinic directors: can digital CBT-I be delivered at scale inside psychosis services without losing the therapeutic precision that makes insomnia treatment effective in the first place?