Chronic InsomniaNCT04300218
Effectiveness and Cost-effectiveness of iCBT-I in Clinical Settings
A study testing internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I) and Care as usual (CAU) in people with Chronic Insomnia, run by I.M. Sechenov First Moscow State Medical University at 3 sites in Russia.
Trial summary
The proposed parallel-group randomized controlled trial add-on superiority of the iCBT-I program with CAU as a control condition will let us investigate the effectiveness and cost-effectiveness of iCBT-I. Analysis of baseline characteristics of the participants aims to find predictors of outcome Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I) and Care as usual (CAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 3 sitesRussia
- Study dates
- 5 Mar 2020to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sleep disorder matching chronic insomnia criteria (International Classification of Sleep Disorders-3) - assessed by clinical judgement
- Ability to follow the procedures of the study, fluent Russian language, Good access to internet - assessed by self-report
Who cannot join
- Presence of dementia (identified by history or a score < 25 on the Folstein Mini Mental Status Exam) - assessed by clinical judgement
- Severe depression or severe anxiety as measured with the Beck Depression Inventory (BDI-II; score > 28 ) and the Beck Anxiety Inventory (BAI; score > 26) - assessed by the questionnaires
- History of severe psychiatric comorbidities other than anxiety and depression (bipolar disorders, psychotic disorders) or substance use disorder - assessed by self-report and clinical history
- Untreated severe obstructive sleep apnea syndrome (apnea-hypopnea index (AHI) > 15), restless legs syndrome (movement index with arousal > 15 per hour) or other sleep disorders affecting night sleep - assessed by clinical judgement and clinical history
- pregnancy, lactation - assessed by self-report
- having a serious somatic condition or brain disorders (stroke, Parkinson's disease…) preventing further participation - assessed by self-report
- Having high suicidality risk - assessed by clinical judgement, high total BDI-II score (> 29) or score >1 on a BDI-II of suicidality subscale
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
Kuzbass clinical veterans hospital
Kemerovo
Sleep medicine department, University clinical hospital 3, I.M.Sechenov First Moscow Medical University
Moscow, Moscow, 119021
Stavropol regional somnological center
Stavropol, Stavropol Kray
About this study
The proposed parallel-group randomized controlled trial add-on superiority of the iCBT-I program with CAU as a control condition will let us investigate the effectiveness and cost-effectiveness of iCBT-I. Analysis of baseline characteristics of the participants aims to find predictors of outcome
Read the detailed description
Application of internet-delivered cognitive-behavior treatment for insomnia (iCBT-I) is a perspective method that can fill the gap created by the discrepancy between insomnia cases and the number of trained professionals. Although the effectiveness of this method was proven in multiple studies conducted in research settings, it is unclear if iCBT-I outperforms pharmacotherapy which remains a widely used alternative of cognitive-behavior therapy of insomnia (CBT-I). Predictors, mediators, and moderators of treatment effect remain uncertain since previous studies often give contradictory results. The present study aims to investigate clinical effectiveness and cost-effectiveness of an internet-based CBT-I program Sleepsy in comparison with care as usual (CAU) among patients with chronic insomnia (CI) recruited from clinical settings. Baseline data will be further analyzed to find predictors of treatment outcome
For these purposes, a parallel-group randomized controlled trial add-on superiority of the iCBT-I program with CAU as a control condition was designed. 110 participants will be referred from the medical doctors in Moscow. Both groups will have access to CAU, treatment prescribed by the referred doctor. Patients of the first group will additionally get access to the iCBT-I program with the opportunity to contact a specialist within the program (guidance on request) in a secured environment. The primary outcome is insomnia severity change from pre- to posttreatment and to post-follow-up. Secondary outcomes include change subjective sleep characteristics, daytime symptoms, comorbid affective disorders, dysfunctional cognitions and behavior, healthcare consumption, and productivity losses. Predictors analysis will include baseline scores of the aforementioned outcomes along with treatment expectancies, personality traits
To the best of our knowledge, the present study is the first study of iCBT-I to be conducted in clinical settings. We expect that this approach lets us determine the target group more precisely and exclude health problems that may interfere with treatment. It is also expected that patients, referred to iCBT-I from the doctor's office will be more motivated to finish the treatment course that will reduce the drop out rate. CAU as control condition let us reconstruct clinical situation facing practicing doctor. On the other hand, CAU may result in a loss of power to detect a meaningful difference. Limitation of our study is in the impossibility of blinding participants to the treatment condition
- Conditions
- Chronic Insomnia
- Being tested
- internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I), Care as usual (CAU)
- Keywords
- cognitive-behavioral psychotherapy, online Intervention, cost-effectiveness, chronic insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I)Behavioural
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)Other
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
| Study group | Role | What they receive |
|---|---|---|
| iCBT-I + CAU | Experimental | 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). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment Receives: Behavioral: internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I); Other: Care as usual (CAU) |
| CAU | Active comparator | 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 Receives: Behavioral: internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I); Other: Care as usual (CAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
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)
Measured: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Secondary outcomes (47)
Sleep Onset Latency (SOL),
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
Measured: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Total Sleep Time (TST)
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
Measured: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Sleep Efficiency (SE)
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
Measured: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Wake After Sleep Onset (WASO)
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
Measured: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Fatigue Severity Scale (FSS)
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
Measured: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Short-form Survey (SF-12 Version 1.0)
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
Measured: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Epworth Sleepiness Scale (ESS)
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
Measured: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Beck Anxiety Inventory (BAI)
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
Measured: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Beck Depression Inventory (BDI-II)
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
Measured: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Sleep Hygiene Index (SHI)
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
Measured: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Sleep Locus of Control Questionnaire (SLC)
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
Measured: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS)
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
Measured: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Anxiousness Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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
Measured: Once at baseline assessment
Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Health Care Consumption
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
Measured: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Short Form- Health and Labour Questionnaire (SF-HLQ)
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
Measured: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Success Expectancy
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
Measured: Once at baseline assessment
User Satisfaction
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
Measured: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
System Usability Scale (SUS)
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.
Measured: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
Number of Completed Modules
Measure of adherence. Program-derived outcome measuring, how many modules were completed (i.e. videolecture, answers to the questions after videolecture)
Measured: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
Total Time Spent on the iCBT-I Website
measure of adherence. Program-derived outcome
Measured: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
Time Spent on Each Module
measure of adherence. Program-derived outcome
Measured: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
Number of Completed Sleep Diaries
measure of adherence. Program-derived outcome
Measured: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
Usage of the Support
number of referrals to the supporting psychologist through the feedback form. Program-derived outcome
Measured: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
Attention Seeking From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Attention seeking 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
Measured: Once at baseline assessment
Callousness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Callousness 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
Measured: Once at baseline assessment
Deceitfulness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Deceitfulness 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
Measured: Once at baseline assessment
Depressivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Depressivity 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
Measured: Once at baseline assessment
Distractability From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Distractability 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
Measured: Once at baseline assessment
Eccentricity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Eccentricity 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
Measured: Once at baseline assessment
Emotional Lability From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Emotional lability 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
Measured: Once at baseline assessment
Grandiosity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Grandiosity 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
Measured: Once at baseline assessment
Hostility From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Hostility 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
Measured: Once at baseline assessment
Impulsivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Impulsivity 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
Measured: Once at baseline assessment
Intimacy Avoidance From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Intimacy avoidance 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
Measured: Once at baseline assessment
Irresponsibility From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Irresponsibility 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
Measured: Once at baseline assessment
Manipulativeness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Manipulativeness 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
Measured: Once at baseline assessment
Perceptual Dysregulation From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Perceptual dysregulation 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
Measured: Once at baseline assessment
Perseveration From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Perseveration 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
Measured: Once at baseline assessment
Restricted Affectivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Restricted affectivity 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
Measured: Once at baseline assessment
Rigid Perfectionism From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Rigid perfectionism 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
Measured: Once at baseline assessment
Risk Taking From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Risk taking 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
Measured: Once at baseline assessment
Separation Insecurity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Separation insecurity 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
Measured: Once at baseline assessment
Submissiveness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Submissiveness 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
Measured: Once at baseline assessment
Suspiciousness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Suspiciousness 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
Measured: Once at baseline assessment
Unusual Beliefs Experience From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Unusual beliefs experience 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
Measured: Once at baseline assessment
Withdrawal From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Withdrawal 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
Measured: Once at baseline assessment
Anhedonia From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
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). Anhedonia 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
Measured: Once at baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start5 Mar 2020
- Primary completion1 Jul 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter parallel-group add-on superiority randomized controlled trial (RCT) comparing an active treatment condition (iCBT-I plus CAU) to CAU alone
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Principal investigator, Poluektov Mikhail Gur'evich, I.M. Sechenov First Moscow State Medical University
- Investigators
- Mikhail G Poluektov, PhD, Principal investigator, I.M.Sechenov First Moscow Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300218
- Sponsor's protocol ID
- 03-20
- Status last verified
- Dec 2025
- First submitted
- 3 Mar 2020
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results of this trial will be disseminated via peer-reviewed journal publications. Primary and secondary aims will be reported in a single publication. Other findings will be published separately. T
Publications
Pchelina P, Poluektov M. Duration of insomnia and success expectancy predict treatment outcome of iCBT for insomnia. Front Sleep. 2024 Nov 6;3:1415077. doi: 10.3389/frsle.2024.1415077. eCollection 2024.
PubMed 41424507Pchelina P, Poluektov M, Krieger T, Duss SB, Berger T. Clinical effectiveness of internet-based cognitive behavioral therapy for insomnia in routine secondary care: results of a randomized controlled trial. Front Psychiatry. 2024 May 10;15:1301489. doi: 10.3389/fpsyt.2024.1301489. eCollection 2024.
PubMed 38800061
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost-effectiveness of iCBT-I in Clinical Settings
- ClinicalTrials.gov ID
- NCT04300218
- Acronym / sponsor ID
- 03-20
- Conditions
- Chronic Insomnia
- Keywords
- cognitive-behavioral psychotherapy, online Intervention, cost-effectiveness, chronic insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 9 Mar 2020 (actual)
- Results
- Posted 7 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed parallel-group randomized controlled trial add-on superiority of the iCBT-I program with CAU as a control condition will let us investigate the effectiveness and cost-effectiveness of iCBT-I. Analysis of baseline characteristics of the participants aims to find predictors of outcome
Detailed description
Application of internet-delivered cognitive-behavior treatment for insomnia (iCBT-I) is a perspective method that can fill the gap created by the discrepancy between insomnia cases and the number of trained professionals. Although the effectiveness of this method was proven in multiple studies conducted in research settings, it is unclear if iCBT-I outperforms pharmacotherapy which remains a widely used alternative of cognitive-behavior therapy of insomnia (CBT-I). Predictors, mediators, and moderators of treatment effect remain uncertain since previous studies often give contradictory results. The present study aims to investigate clinical effectiveness and cost-effectiveness of an internet-based CBT-I program Sleepsy in comparison with care as usual (CAU) among patients with chronic insomnia (CI) recruited from clinical settings. Baseline data will be further analyzed to find predictors of treatment outcome
For these purposes, a parallel-group randomized controlled trial add-on superiority of the iCBT-I program with CAU as a control condition was designed. 110 participants will be referred from the medical doctors in Moscow. Both groups will have access to CAU, treatment prescribed by the referred doctor. Patients of the first group will additionally get access to the iCBT-I program with the opportunity to contact a specialist within the program (guidance on request) in a secured environment. The primary outcome is insomnia severity change from pre- to posttreatment and to post-follow-up. Secondary outcomes include change subjective sleep characteristics, daytime symptoms, comorbid affective disorders, dysfunctional cognitions and behavior, healthcare consumption, and productivity losses. Predictors analysis will include baseline scores of the aforementioned outcomes along with treatment expectancies, personality traits
To the best of our knowledge, the present study is the first study of iCBT-I to be conducted in clinical settings. We expect that this approach lets us determine the target group more precisely and exclude health problems that may interfere with treatment. It is also expected that patients, referred to iCBT-I from the doctor's office will be more motivated to finish the treatment course that will reduce the drop out rate. CAU as control condition let us reconstruct clinical situation facing practicing doctor. On the other hand, CAU may result in a loss of power to detect a meaningful difference. Limitation of our study is in the impossibility of blinding participants to the treatment condition
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter parallel-group add-on superiority randomized controlled trial (RCT) comparing an active treatment condition (iCBT-I plus CAU) to CAU alone
| Arm | Type | Receives |
|---|---|---|
| iCBT-I + CAU | Experimental | Behavioral: internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I), Other: Care as usual (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). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment |
| CAU | Active comparator | Behavioral: internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I), Other: Care as usual (CAU)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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sleep disorder matching chronic insomnia criteria (International Classification of Sleep Disorders-3) - assessed by clinical judgement
- Ability to follow the procedures of the study, fluent Russian language, Good access to internet - assessed by self-report
Key exclusion criteria (7 listed)
- Presence of dementia (identified by history or a score < 25 on the Folstein Mini Mental Status Exam) - assessed by clinical judgement
- Severe depression or severe anxiety as measured with the Beck Depression Inventory (BDI-II; score > 28 ) and the Beck Anxiety Inventory (BAI; score > 26) - assessed by the questionnaires
- History of severe psychiatric comorbidities other than anxiety and depression (bipolar disorders, psychotic disorders) or substance use disorder - assessed by self-report and clinical history
- Untreated severe obstructive sleep apnea syndrome (apnea-hypopnea index (AHI) > 15), restless legs syndrome (movement index with arousal > 15 per hour) or other sleep disorders affecting night sleep - assessed by clinical judgement and clinical history
- pregnancy, lactation - assessed by self-report
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CAU, iCBT-I + 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 | Other | CAU, iCBT-I + CAU |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: 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)
47 secondary outcomes
Sleep Onset Latency (SOL),
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Total Sleep Time (TST)
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Sleep Efficiency (SE)
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Wake After Sleep Onset (WASO)
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Fatigue Severity Scale (FSS)
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Short-form Survey (SF-12 Version 1.0)
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Epworth Sleepiness Scale (ESS)
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Beck Anxiety Inventory (BAI)
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Beck Depression Inventory (BDI-II)
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Sleep Hygiene Index (SHI)
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Sleep Locus of Control Questionnaire (SLC)
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS)
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Anxiousness Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
Time frame: Once at baseline assessment
Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Health Care Consumption
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Short Form- Health and Labour Questionnaire (SF-HLQ)
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Success Expectancy
Time frame: Once at baseline assessment
User Satisfaction
Time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
System Usability Scale (SUS)
Time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
Number of Completed Modules
Time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
Total Time Spent on the iCBT-I Website
Time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
Time Spent on Each Module
Time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
Number of Completed Sleep Diaries
Time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
Usage of the Support
Time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
Attention Seeking From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
Time frame: Once at baseline assessment
Callousness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
Time frame: Once at baseline assessment
Deceitfulness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
Time frame: Once at baseline assessment
Depressivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
Time frame: Once at baseline assessment
Distractability From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
Time frame: Once at baseline assessment
Eccentricity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
Time frame: Once at baseline assessment
Emotional Lability From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
Time frame: Once at baseline assessment
Grandiosity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
Time frame: Once at baseline assessment
Hostility From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
Time frame: Once at baseline assessment
Impulsivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
Time frame: Once at baseline assessment
Intimacy Avoidance From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
Time frame: Once at baseline assessment
Irresponsibility From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
Time frame: Once at baseline assessment
Manipulativeness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
Time frame: Once at baseline assessment
Perceptual Dysregulation From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
Time frame: Once at baseline assessment
Perseveration From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
Time frame: Once at baseline assessment
Restricted Affectivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
Time frame: Once at baseline assessment
Rigid Perfectionism From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
Time frame: Once at baseline assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41424507Pchelina P, Poluektov M. Duration of insomnia and success expectancy predict treatment outcome of iCBT for insomnia. Front Sleep. 2024 Nov 6;3:1415077. doi: 10.3389/frsle.2024.1415077. eCollection 2024.
- Derived from this study: PubMed 38800061Pchelina P, Poluektov M, Krieger T, Duss SB, Berger T. Clinical effectiveness of internet-based cognitive behavioral therapy for insomnia in routine secondary care: results of a randomized controlled trial. Front Psychiatry. 2024 May 10;15:1301489. doi: 10.3389/fpsyt.2024.1301489. eCollection 2024.
- Individual participant dataSharing planned: Yes. Results of this trial will be disseminated via peer-reviewed journal publications. Primary and secondary aims will be reported in a single publication. Other findings will be published separately. T
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail G Poluektov, PhD principal investigator
I.M.Sechenov First Moscow Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I) and Care as usual (CAU) in people with Chronic Insomnia, run by I.M. Sechenov First Moscow State Medical University at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04300218, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.