SleepUp Digital CBTi-based Platform for Insomnia

SleepUp Tecnologia em Saúde

Status: Enrolling

Conditions: Sleep Disorder; Insomnia; Sleep Hygiene

Treatments: Behavioral: Sleep hygiene - minimal intervention; Behavioral: Regular Cognitive Behavioural Therapy for Insomnia; Behavioral: Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies

Study type: Interventional

Funder types: Industry

Identifiers

NCT04949360

SleepUp_#01

34113520.1.0000.5494 (Other Identifier)

Details and patient eligibility

About

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:

• 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. 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:

• 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. Equivalent intervals will be applied to the MI-SH group.

Full 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 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:

• 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.

Phase 2

Those who accepted to participate will be randomized and distributed in three groups:

• 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. 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 4 patient groups, including a placebo group

Standard CBTi (CBTi-S):

Active Comparator group

Description:

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.

Treatment:

Behavioral: Regular Cognitive Behavioural Therapy for Insomnia

Minimal intervention - Sleep hygiene (MI-SH):

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Sleep hygiene - minimal intervention

Online CBTI (CBTI-O)

Experimental group

Description:

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.

Treatment:

Behavioral: Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies

Online CBTi + additional features (CBTi-O+)

Experimental group

Description:

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.

Treatment:

Behavioral: Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies