Evaluation of SleepUp Digital CBTi-based Platform in the Treatment of Insomnia

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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. 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: * Standard CBTi (CBTi-S): This treatment consists of an eight-week treatment composed by weekly and structure appointments with board-certified sleep psychologists. The appointments will be made remotely (video calls with psychologists). * Minimal intervention - Sleep hygiene (MI-SH): This group will receive an educational program on sleep hygiene through the SleepUp app. Its content covers topics that are also covered in the online CBTi sessions. This procedure is more adequate as a control than the commonly used no treatment or waiting list controls, due to the behavioral * Online CBTI (CBTI-O): This group will receive access to an eight-weeks CBTi-based treatment through the SleepUp app. The participants of this group will receive interventions equivalent to the standard in-person CBTi, but provided through a digital platform. * Online CBTi + additional features (CBTi-O+): 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. All participants in all groups will be assessed periodically throughout the eight weeks of intervention with standard sleep questionnaires and sleep logs. Additionally, follow ups will be made at two, four and six months after the end of the intervention. Equivalent intervals will be applied to the MI-SH group.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 60
Healthy Volunteers: f
View:

• Literate Brazilian portuguese speakers.

• Insomnia symptoms (as measured by ISI).

• An Android-based smartphone or tablet with access to the Internet.

Locations
Other Locations
Brazil
SleepUp Tecnologia em Saúde LTDA
RECRUITING
São Caetano Do Sul
Contact Information
Primary
Pesquisa SleepUp
pesquisa@sleepup.com.br
+55 11 93319-1375
Backup
Gabriel N. Pires, PhD
pesquisa@sleepup.com.br
+55 11 933191375
Time Frame
Start Date: 2025-05-19
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 160
Treatments
Active_comparator: Standard CBTi (CBTi-S):
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.
Placebo_comparator: Minimal intervention - Sleep hygiene (MI-SH):
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.
Experimental: Online CBTI (CBTI-O)
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.
Experimental: Online CBTi + additional features (CBTi-O+)
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.
Related Therapeutic Areas
Sponsors
Leads: SleepUp Tecnologia em Saúde Ltda

This content was sourced from clinicaltrials.gov