Effectiveness and Cost-effectiveness of iCBT-I in Clinical Settings

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

Study Overview

• Status: Completed
• Conditions: Chronic Insomnia
• Intervention / Treatment: Behavioral: internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I); Other: Care as usual (CAU)

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 Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russia
  • Kemerovo, Russia
    • Kuzbass clinical veterans hospital
  • Moscow
    • Moscow, Moscow, Russia, 119021
      • Sleep medicine department, University clinical hospital 3, I.M.Sechenov First Moscow Medical University
  • Stavropol Kray
    • Stavropol, Stavropol Kray, Russia
      • Stavropol regional somnological center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment	Behavioral: 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.; Other: 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
Active Comparator: 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	Behavioral: 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.; Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	pre- to post-treatment 2 months, pre-treatment to follow-up 5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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)	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	Once at baseline assessment

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University
• Collaborators: University of Bern
• Investigators: Principal Investigator: Mikhail G Poluektov, PhD, I.M.Sechenov First Moscow Medical University

Publications and helpful links

General 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.
• Pchelina 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2020
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: cost-effectiveness; chronic insomnia; cognitive-behavioral psychotherapy; online Intervention
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 03-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No