Trial Outcomes & Findings for Effectiveness and Cost-effectiveness of iCBT-I in Clinical Settings (NCT NCT04300218)

Results Overview

Change of ISI from pre- to post-treatment and post-follow-up. Change is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of insomnia severity. The ISI is a seven-item insomnia assessment tool. The 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

107 participants

Primary outcome timeframe

pre- to post-treatment 2 months, pre-treatment to follow-up 5 months

Results posted on

2026-01-07

Participant Flow

115 patients with chronic insomnia fulfilling ICSD-3 criteria referred from neurologists specialized in somnology in Moscow (Sleep Medicine department, University Clinic 3, Sechenov First Moscow State Medical University, Moscow) from March 2020 to December 2022 were assessed for eligibility

Participant milestones

Participant milestones
Measure	iCBT-I + CAU Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as Usual (CAU) Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers. All concurrently applied treatments will be assessed repeatedly by self-report
Overall Study STARTED	53	54
Overall Study COMPLETED	47	46
Overall Study NOT COMPLETED	6	8

Reasons for withdrawal

Reasons for withdrawal
Measure	iCBT-I + CAU Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as Usual (CAU) Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers. All concurrently applied treatments will be assessed repeatedly by self-report
Overall Study Lost to Follow-up	6	8

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	iCBT-I + CAU n=53 Participants Demographic characteristics and baseline clinical scores for the study sample were compared with t-test and Chi-square test. iCBT-I + CAU group participants were significantly younger:median (IQR) = 37 (28-50); and had lower FSS: mead (SD) = 36.2 (15.4) Medications used for the management of insomnia included benzodiazepines and hypnotic benzodiazepine receptor agonists, sedating antidepressants, antipsychotics, antihistamines, melatonin, phytotherapy, and off-label substances	Care as Usual (CAU) n=54 Participants Demographic characteristics and baseline clinical scores for the study sample were compared with t-test and Chi-square test. iCBT-I + CAU group participants were significantly older: median (IQR) = 40.5 (34.2-60.5); and had higher FSS: mead (SD) = 43.2 (12.4). Medications used for the management of insomnia included benzodiazepines and hypnotic benzodiazepine receptor agonists, sedating antidepressants, antipsychotics, antihistamines, melatonin, phytotherapy, and off-label substances.	Total n=107 Participants Total of all reporting groups
Age, Continuous	37 years n=53 Participants	40.5 years n=54 Participants	40 years n=107 Participants
Sex: Female, Male Female	30 Participants n=53 Participants	32 Participants n=54 Participants	62 Participants n=107 Participants
Sex: Female, Male Male	23 Participants n=53 Participants	22 Participants n=54 Participants	45 Participants n=107 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Russia	53 participants n=53 Participants	54 participants n=54 Participants	107 participants n=107 Participants
TST - total sleep time	6.7 hours STANDARD_DEVIATION 1.6 • n=53 Participants	6.8 hours STANDARD_DEVIATION 1.6 • n=54 Participants	6.7 hours STANDARD_DEVIATION 1.4 • n=107 Participants
ISI - insomnia severity index	15.4 units on a scale STANDARD_DEVIATION 4.2 • n=53 Participants	15.4 units on a scale STANDARD_DEVIATION 3.9 • n=54 Participants	15.4 units on a scale STANDARD_DEVIATION 4.0 • n=107 Participants
BDI - Beck depression inventory	10.7 units on a scale STANDARD_DEVIATION 5.7 • n=53 Participants	12.4 units on a scale STANDARD_DEVIATION 6.5 • n=54 Participants	11.6 units on a scale STANDARD_DEVIATION 6.2 • n=107 Participants
BAI - Beck anxiety inventory	8.7 units on a scale STANDARD_DEVIATION 6.9 • n=53 Participants	10.3 units on a scale STANDARD_DEVIATION 7.4 • n=54 Participants	9.5 units on a scale STANDARD_DEVIATION 7.1 • n=107 Participants
SF-12 - quality of life short-form survey	31.7 units on a scale STANDARD_DEVIATION 5.6 • n=53 Participants	31.1 units on a scale STANDARD_DEVIATION 5.5 • n=54 Participants	31.4 units on a scale STANDARD_DEVIATION 5.6 • n=107 Participants
FSS - fatigue severity scale	36.2 units on a scale STANDARD_DEVIATION 15.4 • n=53 Participants	43.2 units on a scale STANDARD_DEVIATION 12.4 • n=54 Participants	39.8 units on a scale STANDARD_DEVIATION 14.3 • n=107 Participants
Duration of insomnia	36 months n=53 Participants	48 months n=54 Participants	36 months n=107 Participants
ESS - epworth sleepiness scale	4.8 units on a scale STANDARD_DEVIATION 4.1 • n=53 Participants	5.5 units on a scale STANDARD_DEVIATION 3.9 • n=54 Participants	5.2 units on a scale STANDARD_DEVIATION 4.0 • n=107 Participants
DBAS - dysfunctional beliefs about sleep scale	101.2 units on a scale STANDARD_DEVIATION 25.8 • n=53 Participants	109.8 units on a scale STANDARD_DEVIATION 22.5 • n=54 Participants	105.6 units on a scale STANDARD_DEVIATION 24.5 • n=107 Participants
LCS - locus control of sleep scale	42.2 units on a scale STANDARD_DEVIATION 11.8 • n=53 Participants	41.7 units on a scale STANDARD_DEVIATION 14.0 • n=54 Participants	42.0 units on a scale STANDARD_DEVIATION 12.9 • n=107 Participants
SHI - sleep hygiene index	47.7 units on a scale STANDARD_DEVIATION 8.2 • n=53 Participants	47.5 units on a scale STANDARD_DEVIATION 6.8 • n=54 Participants	47.6 units on a scale STANDARD_DEVIATION 7.5 • n=107 Participants
SE - sleep effectiveness	75.4 percentage of time in bed spent asleep STANDARD_DEVIATION 12.8 • n=53 Participants	78.9 percentage of time in bed spent asleep STANDARD_DEVIATION 11.1 • n=54 Participants	77.2 percentage of time in bed spent asleep STANDARD_DEVIATION 12.1 • n=107 Participants
SOL - sleep onset latency	40.7 minutes STANDARD_DEVIATION 28.7 • n=53 Participants	45.2 minutes STANDARD_DEVIATION 39.6 • n=54 Participants	43.0 minutes STANDARD_DEVIATION 34.6 • n=107 Participants
WASO - wake after sleep onset	40.5 minutes STANDARD_DEVIATION 43.3 • n=53 Participants	32.6 minutes STANDARD_DEVIATION 35.2 • n=54 Participants	36.5 minutes STANDARD_DEVIATION 39.4 • n=107 Participants
Use of medications for insomnia, n (%)	47 Participants n=53 Participants	42 Participants n=54 Participants	89 Participants n=107 Participants
Use of benzodiazepines and/or Z-drugs for insomnia, n (%)	19 Participants n=53 Participants	14 Participants n=54 Participants	33 Participants n=107 Participants

PRIMARY outcome

Timeframe: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months

Change of ISI from pre- to post-treatment and post-follow-up. Change is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of insomnia severity. The ISI is a seven-item insomnia assessment tool. The 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28)

Outcome measures

Outcome measures
Measure	iCBT-I + CAU n=53 Participants Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I): The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as usual (CAU) n=54 Participants Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.
Insomnia Severity Index (ISI) change from pre- to post-treatment	10.0 units on a scale Standard Deviation 5.1	13.5 units on a scale Standard Deviation 5.5
Insomnia Severity Index (ISI) change from pre-treatment to follow-up	11.3 units on a scale Standard Deviation 5.7	13.1 units on a scale Standard Deviation 5.7

SECONDARY outcome

Timeframe: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months

Sleep diary derived measure averaged for 1 week pre- post-treatment, post-follow-up. For the purposes of effectiveness investigation change of SOL from pre- to post-treatment and post-follow-up. Change of SOL is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of sleep latency

Outcome measures

Outcome measures
Measure	iCBT-I + CAU n=53 Participants Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I): The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as usual (CAU) n=54 Participants Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.
Sleep Onset Latency (SOL), change from pre- to post-treatment	28.2 minutes Standard Deviation 29.0	39.2 minutes Standard Deviation 37.2
Sleep Onset Latency (SOL), change from pre-treatment to follow-up	33.3 minutes Standard Deviation 28.2	42.5 minutes Standard Deviation 37.1

SECONDARY outcome

Timeframe: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months

Sleep diary derived measure averaged for 1 week pre- post-treatment, post-follow-up. For the purposes of effectiveness investigation change of TST from pre- to post-treatment and post-follow-up. Change of TST is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the worse outcome, negative values correspond to the better outcome, i.e. increase of total sleep time

Outcome measures

Outcome measures
Measure	iCBT-I + CAU n=53 Participants Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I): The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as usual (CAU) n=54 Participants Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.
Total Sleep Time (TST) pre- to post-treatment change	6.9 hours Standard Deviation 1.3	7.0 hours Standard Deviation 1.2
Total Sleep Time (TST) change from pre-treatment to follow-up	7.3 hours Standard Deviation 1.3	7.0 hours Standard Deviation 1.1

SECONDARY outcome

Timeframe: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months

Sleep diary derived measure calculated as the ratio of TST to time spent in bed multiplied by 100%, averaged for 1 week pre- post-treatment, post-follow-up. For the purposes of effectiveness investigation change of SOL from pre- to post-treatment and post-follow-up. Change of SE is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the worse outcome, negative values correspond to the better outcome, i.e. increase of sleep efficiency

Outcome measures

Outcome measures
Measure	iCBT-I + CAU n=53 Participants Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I): The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as usual (CAU) n=54 Participants Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.
Sleep Efficiency (SE) change pre- to post-treatment	84.5 percent Standard Deviation 10.4	81.9 percent Standard Deviation 9.9
Sleep Efficiency (SE) change from pre-treatment to follow-up	83.8 percent Standard Deviation 8.2	80.2 percent Standard Deviation 11.9

SECONDARY outcome

Timeframe: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months

Sleep diary derived measure averaged for 1 week pre- post-treatment, post-follow-up. For the purposes of effectiveness investigation change of WASO from pre- to post-treatment and post-follow-up. Change of WASO is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of the time spent awake after sleep onset

Outcome measures

Outcome measures
Measure	iCBT-I + CAU n=53 Participants Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I): The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as usual (CAU) n=54 Participants Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.
Wake After Sleep Onset (WASO) change pre- to post-treatment	19.0 minutes Standard Deviation 16.7	28.0 minutes Standard Deviation 35.2
Wake After Sleep Onset (WASO) change pre-treatment to follow-up	28.8 minutes Standard Deviation 22.0	29.3 minutes Standard Deviation 29.3

SECONDARY outcome

Timeframe: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months

Disorder non-specific 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle. Each item is evaluated on the 7 points Likert scale (e.g., 1 indicates strongly disagree and 7=strongly agree.), yielding a total score ranging from 9 to 63. A higher score reflects a higher level of fatigue. Change of FSS was calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of fatigue

Outcome measures

Outcome measures
Measure	iCBT-I + CAU n=53 Participants Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I): The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as usual (CAU) n=54 Participants Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.
Fatigue Severity Scale (FSS) change from pre- to post-treatment	35.1 units on a scale Standard Deviation 14.0	40.6 units on a scale Standard Deviation 13.8
Fatigue Severity Scale (FSS) change from pre-treatment to follow-up	33.3 units on a scale Standard Deviation 14.9	38.3 units on a scale Standard Deviation 15.2

SECONDARY outcome

Timeframe: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months

The Short Form Survey (SF-12)is calculated as a summary of the mental component score (MCS-12) and a physical component score (PCS-12). Total score ranges from 0 to 100, with higher scores indicating better functioning. The subscale scores are represented as T-scores with a mean of 50 and a standard deviation of 10 in the general population. A score of \< 50 on the PCS-12 is a cut-off to determine a physical condition; score of \<42 on the MCS-12 may be indicative of 'clinical depression'. For this study we used change of the SF-12 total score as outcome. Change of SF-12 is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the worse outcome, negative values correspond to the better outcome, i.e. increase of physical and mental health functioning

Outcome measures

Outcome measures
Measure	iCBT-I + CAU n=53 Participants Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I): The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as usual (CAU) n=54 Participants Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.
Short-form Survey (SF-12 Version 1.0) change from pre-treatment to follow-up	33.7 units on a scale Standard Deviation 6.6	32.8 units on a scale Standard Deviation 6.2
Short-form Survey (SF-12 Version 1.0) change pre- to post-treatment	34.7 units on a scale Standard Deviation 5.6	33.1 units on a scale Standard Deviation 6.3

SECONDARY outcome

Timeframe: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months

Measure asking propensity for 'dosing' in eight daytime situations from 0 = never to 3= very high propensity, yielding a total score ranging from 0 to 24 with normal score \< 9. Change of ESS is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of daytime sleepiness

Outcome measures

Outcome measures
Measure	iCBT-I + CAU n=53 Participants Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I): The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as usual (CAU) n=54 Participants Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.
Epworth Sleepiness Scale (ESS) change from pre- to post-treatment	4.4 units on a scale Standard Deviation 3.9	4.1 units on a scale Standard Deviation 3.6
Epworth Sleepiness Scale (ESS) change from pre-treatment to follow-up	3.9 units on a scale Standard Deviation 4.5	4.0 units on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months

21-questions inventory with a 4-point Likert scale and ranging answers from 0 to 3, yielding a total score ranging from 0 to 63. A BAI total score higher than 25 corresponds to severe anxiety. Change of BAI is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of anxiety

Outcome measures

Outcome measures
Measure	iCBT-I + CAU n=53 Participants Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I): The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as usual (CAU) n=54 Participants Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.
Beck Anxiety Inventory (BAI) Change from pre- to post-treatment	7.0 units on a scale Standard Deviation 6.4	9.8 units on a scale Standard Deviation 7.7
Beck Anxiety Inventory (BAI) Change from pre-treatment to follow-up	8.3 units on a scale Standard Deviation 7.9	9.3 units on a scale Standard Deviation 7.6

SECONDARY outcome

Timeframe: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months

1-questions inventory with a 4-point Likert scale and ranging answers from 0 to 3, yielding a total score ranging from 0 to 63. A BDI cutoff higher than 28 indicates severe depression. Change of BDI-II is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of depression

Outcome measures

Outcome measures
Measure	iCBT-I + CAU n=53 Participants Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I): The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as usual (CAU) n=54 Participants Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.
Beck Depression Inventory (BDI-II) Change from pre- to post-treatment	6.7 units on a scale Standard Deviation 5.2	10.2 units on a scale Standard Deviation 5.4
Beck Depression Inventory (BDI-II) Change from pre-treatment to follow-up	8.0 units on a scale Standard Deviation 6.2	10.3 units on a scale Standard Deviation 7.0

SECONDARY outcome

Timeframe: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months

13-questions questionnaire evaluating each item on a 5-point Likert scale, yielding a total score ranging from 13 to 65. Higher SHI score corresponds to the worse sleep hygiene. Change of SHI is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. worsening of sleep hygiene habits

Outcome measures

Outcome measures
Measure	iCBT-I + CAU n=53 Participants Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I): The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as usual (CAU) n=54 Participants Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.
Sleep Hygiene Index (SHI) change from pre-treatment to follow-up	27.7 units on a scale Standard Deviation 7.7	28.5 units on a scale Standard Deviation 6.3
Sleep Hygiene Index (SHI) change from pre- to post-treatment	51.9 units on a scale Standard Deviation 7.2	49.8 units on a scale Standard Deviation 6.5

SECONDARY outcome

Timeframe: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months

variant validated in Russia comprises 8 questions scored using a 6-point Likert scale ranging each answer from 1 = strongly disagree; 6 = strongly agree, yielding a total score ranging from 8 to 48. The Russian adaptation of the scale has shown internal reliability of 0.41. Higher SLC score corresponds to the more marked external locus of control. Change of SLC is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. more prominent external locus of control of sleep

Outcome measures

Outcome measures
Measure	iCBT-I + CAU n=53 Participants Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I): The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as usual (CAU) n=54 Participants Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.
Sleep Locus of Control Questionnaire (SLC) change from pre- to post-treatment	38.5 units on a scale Standard Deviation 9.6	38.6 units on a scale Standard Deviation 9.9
Sleep Locus of Control Questionnaire (SLC) change from pre-treatment to folow-up	39.8 units on a scale Standard Deviation 12.0	40.1 units on a scale Standard Deviation 13.6

SECONDARY outcome

Timeframe: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months

designed to identify and assess the severity of various sleep and insomnia-related cognitions. It consists of 16 questions with a Likert scale ranging answers from 0 = strongly disagree to 10 = strongly agree with a total score ranging from 0 to 160. Higher DBAS score reflects more severe dysfunctional thinking. The Russian adaptation of the scale has high internal reliability of 0.86. Change of DBAS is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. more prominent dysfunctional beliefs about sleep

Outcome measures

Outcome measures
Measure	iCBT-I + CAU n=53 Participants Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I): The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as usual (CAU) n=54 Participants Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.
Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS) change from pre- to post-treatment	75.3 units on a scale Standard Deviation 31.5	95.8 units on a scale Standard Deviation 27.2
Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS) change from pre-treatment to follow-up	76.1 units on a scale Standard Deviation 33.6	99.3 units on a scale Standard Deviation 27.7

SECONDARY outcome

Timeframe: Once at baseline assessment

100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Anxiousness is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet

Outcome measures

Outcome measures
Measure	iCBT-I + CAU n=53 Participants Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I): The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as usual (CAU) n=54 Participants Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.
Anxiousness Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement	2.43 score on a scale Standard Error 0.84	2.62 score on a scale Standard Error 0.75

SECONDARY outcome

Timeframe: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months

This measure aims to evaluate the cost-effectiveness of iCBT-I. The first part of TIC-P consists of 14 questions on the volume of health care uptake: including the number of medical consultations, dose, and frequency of medication, days of inpatient care. Multiplication of these data by the actual price of medical help produces the cost of medical care as the outcome. The higher outcome represents higher costs of medical care. Change of TiC-P Health care consumption is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. higher costs of the healthcare consumption

Outcome measures

Outcome measures
Measure	iCBT-I + CAU n=53 Participants Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I): The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as usual (CAU) n=54 Participants Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.
Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Health Care Consumption Change from pre- to post-treatment	16500 roubles Interval 12100.0 to 26818.0	4896 roubles Interval 0.0 to 9340.0
Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Health Care Consumption Change from pre-treatment to follow-up	6263 roubles Interval 790.0 to 16630.0	5959 roubles Interval 1333.0 to 10097.0

SECONDARY outcome

Timeframe: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months

This measure aims to evaluate the cost-effectiveness of iCBT-I. The second part of TIC-P is represented by the Short Form- Health and Labour Questionnaire (SF-HLQ), an instrument to collect data on productivity losses (presenteeism and absenteeism) due to health problems. Costs of productivity losses are calculated by multiplication of missed working hours by standard cost price of productivity. The higher outcome represents higher costs of productivity losses. Change of TiC-P productivity losses is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. higher costs of the productivity losses

Outcome measures

Outcome measures
Measure	iCBT-I + CAU n=53 Participants Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I): The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as usual (CAU) n=54 Participants Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.
Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Short Form- Health and Labour Questionnaire (SF-HLQ) Change from pre- to post-treatment	2449 roubles Interval 0.0 to 17975.0	7238 roubles Interval 0.0 to 14694.0
Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Short Form- Health and Labour Questionnaire (SF-HLQ) Change from pre-treatment to follow-up	1196 roubles Interval 0.0 to 7698.0	2853 roubles Interval 396.0 to 8002.0

SECONDARY outcome

Timeframe: Once at baseline assessment

Aims to measure patients' beliefs about the expected treatment success as one of the important outcome predictors. For its evaluation we will use one adapted question of Credibility/Expectancy Questionnaire: "At this point, how successfully do you think this treatment will be in reducing your insomnia symptoms?" at scale from 1 to 9. This question was chosen as well representing high correlation for both factors: credibility and expectancy, and most logically formulated for the intended purpose

Outcome measures

Outcome measures
Measure	iCBT-I + CAU n=53 Participants Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I): The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as usual (CAU) n=54 Participants Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.
Success Expectancy	6.3 score on a scale Standard Error 1.57	6.2 score on a scale Standard Error 1.64

SECONDARY outcome

Timeframe: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU

feedback questionnaire developed for this study. It includes 1 question about satisfaction or dissatisfaction with the treatment with a 5-point Likert scale, from 1 (very poor/not at all useful) to 5 (very, good/very useful). The questionnaire also contains open questions aiming for utilitarian goals, i.e. to improve the program (possible negative effects of the intervention if any: deterioration of insomnia symptoms, adverse effects, novel symptoms; and about improvement suggestions, what participants liked most if they would recommend it to a friend with insomnia). These questions are not included in questionnaire score

Outcome measures

Outcome measures
Measure	iCBT-I + CAU n=53 Participants Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I): The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as usual (CAU) n=1 Participants Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.
User Satisfaction	3.7 score on a scale Standard Error 1.28	5.0 score on a scale Standard Error NA Only 1 participant of CAU group replied this question

SECONDARY outcome

Timeframe: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU

Population: data were not analyzed

10-item non-specific questionnaire used to collect a user's subjective rating of a product's (products, websites, applications, hardware, or software) usability and learnability. Each item is scored on a scale of 0 ("strongly Disagree") to 4 ("strongly Agree"). For positively-worded items (1, 3, 5, 7 and 9), the score contribution is the scale position minus 1. For negatively-worded items (2, 4, 6, 8 and 10), it is 5 minus the scale position. To get the overall SUS score, multiply the sum of the item score contributions by 2.5. Thus, SUS scores range from 0 to 100 in 2.5-point increments. Higher SUS score reflects better subjective usability of the program.

Outcome measures

Outcome measures
Measure	iCBT-I + CAU n=53 Participants Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I): The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as usual (CAU) n=1 Participants Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.
System Usability Scale (SUS)	32.8 score on a scale Standard Error 25.1	10 score on a scale Standard Error NA Below the level of detection Only 1 participant of CAU group has answered this question

SECONDARY outcome

Timeframe: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU

Measure of adherence. Program-derived outcome measuring, how many modules were completed (i.e. videolecture, answers to the questions after videolecture)

Outcome measures

Outcome measures
Measure	iCBT-I + CAU n=53 Participants Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I): The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study. Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.	Care as usual (CAU) n=54 Participants Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment Care as usual (CAU): Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers.
Number of Completed Modules	6.54 number of completed modules Standard Error 2.41	4.93 number of completed modules Standard Error 3.28

SECONDARY outcome

Timeframe: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU

Population: although data were automatically collected by the software, its further analysis was not possible due to the technical problems to extract the data and to use them in the analysis, since it could be done only by a software developer who has left the project earlier. Data are not planned to be analyzed in the future

measure of adherence. Program-derived outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU

iCBT-I + CAU

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Care as Usual (CAU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Polina Pchelina

IMSechenovMMA

Phone: +79036701725

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place