SleepUp Digital CBTi-based Platform for Insomnia

Study Overview
=================
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 informative material regarding normal sleep pattern and sleep hygiene (through regular mail and e-mail). 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-month 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, the sleep log and the clinical tests 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. The treatment last eight weeks. 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 SH-MI 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 SleepUp's records and database 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. Due to the restriction imposed by the COVID-19 pandemic, 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 regular mail and e-mail). 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-month 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, the sleep log and the clinical tests 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. The treatment last eight weeks. 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.

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

Conditions
-----------------
Insomnia, Sleep Disorder, Sleep Hygiene

Intervention / Treatment
-----------------
* Behavioral: Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies
* Behavioral: Regular Cognitive Behavioural Therapy for Insomnia
* Behavioral: Sleep hygiene - minimal intervention


Participation Criteria
=================
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. Presence of self-reported co-morbidities (hypertension, hyper/hypothyroidism, asthma, bronquitis or other respiratory diseases, rhinitis, epilepsy and other neurological diseases, any psychiatric disease other than depression and anxiety, diabetes) or sleep disoders other than insomnia.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized and distributed in four parallel and independent groups.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard CBTi (CBTi-S):<br>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. Due to the restriction imposed by the COVID-19 pandemic, 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<br>* 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.<br>|
| Placebo Comparator: Minimal intervention - Sleep hygiene (MI-SH):<br>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 regular mail and e-mail). 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<br>* It is composed by educational material about normal sleep pattern and sleep hygiene. It will be delivered by regular mail and email.<br>|
| Experimental: Online CBTI (CBTI-O)<br>This group will receive access to an eight-month 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, the sleep log and the clinical tests 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. The treatment last eight weeks. | Behavioral: Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies<br>* 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.<br>|
| Experimental: Online CBTi + additional features (CBTi-O+)<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 (SL-MI). | On the completion of the intervention (average: 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. | On the baseline and on the completion of the intervention (average: 8 weeks) | 
| Remission of symptoms | Patients are considered to be with no symptoms of insomnia if the ISI score is lower then 8. | On the completion of the intervention (average: 8 weeks) | 
| Maintenance of results | Among those patients who completed the treatment program, maintenance of results will be calculated based on the same metrics of response to treatment and remission of symptoms. | 6 months after the end of the treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 (SL-MI). | 2 weeks after the beginning of the intervention. | 
| 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 (SL-MI). | 4 weeks after the beginning of the intervention. | 
| 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 (SL-MI). | 6 weeks after the beginning of the intervention. | 
| 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. | On the baseline and 2 weeks after the beginning of the intervention. | 
| 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. | On the baseline and 4 weeks after the beginning of the intervention. | 
| 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. | On the baseline and 6 weeks after the beginning of the intervention. | 
| Remission of symptoms | Patients are considered to be with no symptoms of insomnia if the ISI score is lower then 8. | 2 weeks after the beginning of the intervention. | 
| Remission of symptoms | Patients are considered to be with no symptoms of insomnia if the ISI score is lower then 8. | 4 weeks after the beginning of the intervention. | 
| Remission of symptoms | Patients are considered to be with no symptoms of insomnia if the ISI score is lower then 8. | 6 weeks after the beginning of the intervention. | 
| Maintenance of results | Among those patients who completed the treatment program, maintenance of results will be calculated based on the same metrics of response to treatment and remission of symptoms. | 2 months after the end of the treatment. | 
| Maintenance of results | Among those patients who completed the treatment program, maintenance of results will be calculated based on the same metrics of response to treatment and remission of symptoms. | 4 months after the end of the treatment. | 
| Sleep quality | Sleep quality will be measured by the Pittsburgh Sleep Quality Index | 2 weeks after the beginning of the treatment | 
| Sleep quality | Sleep quality will be measured by the Pittsburgh Sleep Quality Index | 4 weeks after the beginning of the treatment | 
| Sleep quality | Sleep quality will be measured by the Pittsburgh Sleep Quality Index | 6 weeks after the beginning of the treatment | 
| Sleep quality | Sleep quality will be measured by the Pittsburgh Sleep Quality Index | On the completion of the treatment | 
| Sleep quality | Sleep quality will be measured by the Pittsburgh Sleep Quality Index | 2 months after the end of the treatment | 
| Sleep quality | Sleep quality will be measured by the Pittsburgh Sleep Quality Index | 4 months after the end of the treatment | 
| Sleep quality | Sleep quality will be measured by the Pittsburgh Sleep Quality Index | 6 months after the end of the treatment | 
| Sleep hygiene | Sleep hygiene habits will be measured by the Sleep Hygiene Index | 2 weeks after the beginning of the treatment | 
| Sleep hygiene | Sleep hygiene habits will be measured by the Sleep Hygiene Index | 4 weeks after the beginning of the treatment | 
| Sleep hygiene | Sleep hygiene habits will be measured by the Sleep Hygiene Index | 6 weeks after the beginning of the treatment | 
| Sleep hygiene | Sleep hygiene habits will be measured by the Sleep Hygiene Index | On the completion of the treatment | 
| Sleep hygiene | Sleep hygiene habits will be measured by the Sleep Hygiene Index | 2 months after the end of the treatment | 
| Sleep hygiene | Sleep hygiene habits will be measured by the Sleep Hygiene Index | 4 months after the end of the treatment | 
| Sleep hygiene | Sleep hygiene habits will be measured by the Sleep Hygiene Index | 6 months after the end of the treatment | 
| Excessive daytime sleepiness | Excessive daytime sleepiness will be measured using the Epworth Sleepiness Scale | 2 weeks after the beginning of the treatment | 
| Excessive daytime sleepiness | Excessive daytime sleepiness will be measured using the Epworth Sleepiness Scale | 4 weeks after the beginning of the treatment | 
| Excessive daytime sleepiness | Excessive daytime sleepiness will be measured using the Epworth Sleepiness Scale | 6 weeks after the beginning of the treatment | 
| Excessive daytime sleepiness | Excessive daytime sleepiness will be measured using the Epworth Sleepiness Scale | On the completion of the treatment | 
| Excessive daytime sleepiness | Excessive daytime sleepiness will be measured using the Epworth Sleepiness Scale | 2 months after the end of the treatment | 
| Excessive daytime sleepiness | Excessive daytime sleepiness will be measured using the Epworth Sleepiness Scale | 4 months after the end of the treatment | 
| Excessive daytime sleepiness | Excessive daytime sleepiness will be measured using the Epworth Sleepiness Scale | 6 months after the end of the treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insomnia, Sleep, Cognitive-behavioral therapy, CBTi