An interventional study of Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies and Regular Cognitive Behavioural Therapy for Insomnia in Insomnia, Sleep Disorder and Sleep Hygiene, sponsored by SleepUp Tecnologia em Saúde Ltda. Recruiting at 1 site in Brazil. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by SleepUp Tecnologia em Saúde Ltda · Not applicable, Interventional, and Treatment
Cognitive-Behavioral Therapy for insomnia (CBTi) is a well-established therapeutic intervention for insomnia. SleepUp provides a digital therapeutics platform based on CBTi and additional features. This clinical trial aims at analyzing the efficacy of the CBTi-based platform offered by SleepUp in reducing symptoms of insomnia and will be conducted in 2 phases.
Phase 1
The sample will be composed of 160 individuals, both males and females, from 20 to 60 years old, with insomnia symptoms considered as at least mild. Those who accept to participate will be randomized and distributed in four groups:
All participants in all groups will be assessed periodically throughout the eight weeks of intervention with standard sleep questionnaires and sleep logs. Equivalent intervals will be applied to the MI-SH group.
Phase 2
This phase will comprise 120 individuals, both males and females, from 20 to 60 years old, with insomnia symptoms considered as at least mild. Those who accept to participate will be randomized and distributed in three groups:
All participants in all groups will be assessed periodically throughout the eight weeks of intervention with standard sleep questionnaires and sleep logs. Equivalent intervals will be applied to the MI-SH group.
Cognitive-Behavioral Therapy for insomnia (CBTi) is a well-established therapeutic intervention for insomnia. In its standard presentation, it is composed by 6 to 12 weekly appointments with a board-certified sleep psychologist. SleepUp provides a digital therapeutics platform based on CBTi and additional features. This clinical trial aims at analyzing the efficacy of the CBTi-based platform offered by SleepUp in reducing symptoms of insomnia.
The participants will be recruited based on advertising on social media and invited to participate. Those participants who are eligible in accordance to the inclusion and exclusion criteria will be contact by a member of the research team who will provide a consent form and will explain the terms and conditions of this research project. The sample will be composed of 160 individuals in Phase 1 and by 120 individuals in Phase 2, both males and females, from 20 to 60 years old, with insomnia symptoms considered as at least mild, according to the Insomnia Severity Index (ISI). All groups shall have similar proportions of gender and of insomnia symptoms severity.
Phase 1
Those who accepted to participate will be randomized and distributed in four groups:
Phase 2
Those who accepted to participate will be randomized and distributed in three groups:
All participants in all groups will be assessed periodically throughout the eight weeks of intervention. Equivalent intervals will be applied to the SH-MI group. The following clinical questionnaires and scales will be used:
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This study's planned enrollment of 280 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
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Exclusion Criteria:
This is a positive control group/active comparator, in which standard CBTi (the golden standard behavioral treatment for insomnia) will be made available. This treatment consists of an eight-week treatment composed by weekly and structured appointments with a board-certified sleep psychologist. The professionals performing the CBTi sessions will not be part of the research team. The appointments will be made remotely (video calls with psychologists), which have already been proven to be equivalent to the in-person CBTi.
Behavioral: Regular Cognitive Behavioural Therapy for Insomnia
This group corresponds to a negative control group/placebo comparator, subjected to minimal intervention. It is based on the delivery of informative material regarding normal sleep pattern and sleep hygiene (through SleepUp app). This procedure is more adequate as a control than the commonly used no-treatment or waiting list controls, due to the behavioral nature of insomnia.
Behavioral: Sleep hygiene - minimal intervention
This group will receive access to an eight-week CBTi-based treatment through the SleepUp app. The platform will be updated into a non-commercial version, and all features other than the CBTi track will be removed. This way, the participants of this group will receive interventions equivalent to the standard in-person CBTi, but provided through a digital platform.
Behavioral: Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies
This group will have access to the complete premium version of SleepUp platform. It includes those presented in the CBTi-O group and other therapeutic and complementary features (including meditation audios and videos, mindfulness therapy, relaxation soundtracks, sleep hygiene tips, virtual assistant, and telehealth.
Behavioral: Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies
The CBTi-O and CBTi-O+ interventions are based on real life user experience. The users will have access to different versions of the platform. The intervention will last eitght weeks.
This is the gold standard behavioral treatment for insomnia and will be performed by independent board-certified sleep psychologists. The treatments will last eight weeks and the appointments will be made by video-calls.
It is composed by educational material about normal sleep pattern and sleep hygiene. It will be delivered by SleepUp app.
Adherence to the treatment
It will be measured as the percentage of participants who completed the treatment, out of those who effectively initiated it. Dropouts will be considered whenever a participants fail to comply with the tasks relative to each group for two consecutive weeks, or postpone the completion of these tasks for three times. These tasks refer to the responses to periodic questionnaires and to the completion of the CBTi or CBTi-O sessions (when applicable).The aim of this comparison is to evaluate whether the adherence rate in the CBTi-O and CBTi-O+ groups are similar to the standard treatment (CBTi-S) or higher than the minimal treatment (MI-SH).
Time frame: From enrollment (baseline) to the end of treatment at 8 weeks
Response to treatment
Patients are considered to be responsive to treatment if the ISI score is at least 7 points lower than on the basal evaluation.
Time frame: From enrollment (baseline) to the end of treatment at 8 weeks
Remission of symptoms
Patients are considered to be with no symptoms of insomnia if the ISI score is lower then 8.
Time frame: From enrollment (baseline) to the end of treatment at 8 weeks
Self-reported sleep efficiency
Sleep efficiency will be measured by sleep logs
Time frame: From enrollment (baseline) to the end of treatment at 8 weeks
Sleep hygiene
Sleep hygiene habits will be measured by the Sleep Hygiene Index
Time frame: From enrollment (baseline) to the end of treatment at 8 weeks
Excessive daytime sleepiness
Excessive daytime sleepiness will be measured using the Epworth Sleepiness Scale
Time frame: From enrollment (baseline) to the end of treatment at 8 weeks
Sleep quality
Sleep quality will be measured by the Pittsburgh Sleep Quality Index
Time frame: From enrollment (baseline) to the end of treatment at 8 weeks
Self-reported sleep latency
Sleep latency will be measured by sleep logs
Time frame: From enrollment (baseline) to the end of treatment at 8 weeks
Self-reported sleep duration
Sleep duration will be measured by sleep logs
Time frame: From enrollment (baseline) to the end of treatment at 8 weeks
Plan to share: No — The dissemination of Individual Participant Data (IPD) from this study is strictly limited by restrictions on the release of intellectual property, concerns regarding participant privacy and confidentiality, and the absence of explicit consent for extensive data sharing. However, upon reasonable request and subject to approval by the study's principal investigator, anonymized datasets may be provided to qualified researchers. It is imperative that requests include a thorough research proposal and a rationale that substantiates the need for the resources in question.
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