Clinical trial NCT04949360: SleepUp Digital CBTi-based Platform for Insomnia
Official title: Evaluation of SleepUp Digital CBTi-based Platform in the Treatment of Insomnia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Sleep Disorder
Sleep Hygiene
Keywords: Insomnia
Sleep
Cognitive-behavioral therapy
CBTi
Lead sponsor: SleepUp Tecnologia em Saúde Ltda
Sponsor class: INDUSTRY
First posted: 2021-07-02
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized and distributed in four parallel and independent groups.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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, 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. Those who accepted to participate will be randomized and distributed in four groups:

* Standard CBTi (CBTi-S): This is a positive control group, 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 structure appointments with psychologists. Only psychologists board-certified in sleep medicine will perform the CBTi sessions, and none of them are 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.
* Minimal intervention - Sleep hygiene (MI-SH): This group corresponds to a negative control group, 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.
* 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. This way, 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. 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 SH-MI group. The following clinical questionnaires and scales will be used:

* Sleep log: It includes self-reported items regarding wake and bedtime, sleep latency and other sleeping habits. It allows the calculation of total sleep time, sleep efficiency and wake time after sleep onset. Fille daily.
* Morningness and Eveningness Questionnaire: It evaluates chronotype based on 19 items, allowing categorizing the participants according to the following categories: morning type (definitive or moderate), intermediate, or evening type (definitive or moderate). Applied once, in the first week of follow up.
* Insomnia Severity Index: It evaluates the presence and severity of insomnia, categorizing the participants according to the following categories: no, mild, moderate or severe insomnia. Applied once every two weeks.
* Epworth Sleepiness Scale: It evaluates excessive daytime sleepiness by inquiring about the chance of sleeping in eight daily situations. Scores higher than 10 indicates excessive daytime sleepiness. Applied once every two weeks.
* Pittsburgh Sleep Quality Index: It evaluates overall sleep quality based on 19 self-reported items. Scores higher than 5 indicates poor sleep quality. Applied once every two weeks.
* Sleep Hygiene Index: It habits related to sleep hygiene, based on 13 self-reported items.

Eligibility criteria: Inclusion Criteria:

* Literate Brazilian portuguese speakers.
* Insomnia symptoms (as measured by ISI).
* An Android-based smartphone or tablet with access to the Internet.

Exclusion Criteria:

* Previous experience with CBTi.
* Use of sleeping pills or any other treatment for insomnia for two or more days a week in the last three months.

Primary outcomes:
measure: Adherence to the treatment
timeFrame: On the completion of the intervention (average: 8 weeks)
measure: Response to treatment
timeFrame: On the baseline and on the completion of the intervention (average: 8 weeks)
measure: Remission of symptoms
timeFrame: On the completion of the intervention (average: 8 weeks)
measure: Maintenance of results
timeFrame: 6 months after the end of the treatment.
Secondary outcomes:
measure: Adherence to the treatment
timeFrame: 2 weeks after the beginning of the intervention.
measure: Adherence to the treatment
timeFrame: 4 weeks after the beginning of the intervention.
measure: Adherence to the treatment
timeFrame: 6 weeks after the beginning of the intervention.
measure: Response to treatment
timeFrame: On the baseline and 2 weeks after the beginning of the intervention.
measure: Response to treatment
timeFrame: On the baseline and 4 weeks after the beginning of the intervention.
measure: Response to treatment
timeFrame: On the baseline and 6 weeks after the beginning of the intervention.
measure: Remission of symptoms
timeFrame: 2 weeks after the beginning of the intervention.
measure: Remission of symptoms
timeFrame: 4 weeks after the beginning of the intervention.
measure: Remission of symptoms
timeFrame: 6 weeks after the beginning of the intervention.
measure: Maintenance of results
timeFrame: 2 months after the end of the treatment.
measure: Maintenance of results
timeFrame: 4 months after the end of the treatment.
measure: Sleep quality
timeFrame: 2 weeks after the beginning of the treatment
measure: Sleep quality
timeFrame: 4 weeks after the beginning of the treatment
measure: Sleep quality
timeFrame: 6 weeks after the beginning of the treatment
measure: Sleep quality
timeFrame: On the completion of the treatment
measure: Sleep quality
timeFrame: 2 months after the end of the treatment
measure: Sleep quality
timeFrame: 4 months after the end of the treatment
measure: Sleep quality
timeFrame: 6 months after the end of the treatment
measure: Sleep hygiene
timeFrame: 2 weeks after the beginning of the treatment
measure: Sleep hygiene
timeFrame: 4 weeks after the beginning of the treatment
measure: Sleep hygiene
timeFrame: 6 weeks after the beginning of the treatment
measure: Sleep hygiene
timeFrame: On the completion of the treatment
measure: Sleep hygiene
timeFrame: 2 months after the end of the treatment
measure: Sleep hygiene
timeFrame: 4 months after the end of the treatment
measure: Sleep hygiene
timeFrame: 6 months after the end of the treatment
measure: Excessive daytime sleepiness
timeFrame: 2 weeks after the beginning of the treatment
measure: Excessive daytime sleepiness
timeFrame: 4 weeks after the beginning of the treatment
measure: Excessive daytime sleepiness
timeFrame: 6 weeks after the beginning of the treatment
measure: Excessive daytime sleepiness
timeFrame: On the completion of the treatment
measure: Excessive daytime sleepiness
timeFrame: 2 months after the end of the treatment
measure: Excessive daytime sleepiness
timeFrame: 4 months after the end of the treatment
measure: Excessive daytime sleepiness
timeFrame: 6 months after the end of the treatment
Other outcomes:
Locations:
city: São Caetano Do Sul
country: Brazil
facility: SleepUp Tecnologia em Saúde LTDA
state: São Paulo
Study officials:
affiliation: Universidade Federal de São Paulo
name: Gabriel N. Pires, PhD
role: PRINCIPAL_INVESTIGATOR
References: