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

Chronic Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04300218
• Other study ID #: 03-20
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2020
• Est. completion date: March 28, 2023

Study information

• Verified date: February 2023
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: Polina V Pchelina, PhD
• Phone: +79036701725
• Email: polbox[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 28, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Kuzbass clinical veterans hospital	Kemerovo
Russian Federation	Sleep medicine department, University clinical hospital 3, I.M.Sechenov First Moscow Medical University	Moscow
Russian Federation	Stavropol regional somnological center	Stavropol	Stavropol Region

Sponsors (2)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University	University of Bern

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Severity Index (ISI)	Change of ISI from pre- to post-treatment and post-follow-up. 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- to post-follow-up 5 months
Secondary	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	pre- to post-treatment 2 months, pre- to post-follow-up 5 months
Secondary	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 SOL from pre- to post-treatment and post-follow-up	pre- to post-treatment 2 months, pre- to post-follow-up 5 months
Secondary	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	pre- to post-treatment 2 months, pre- to post-follow-up 5 months
Secondary	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 SOL from pre- to post-treatment and post-follow-up	pre- to post-treatment 2 months, pre- to post-follow-up 5 months
Secondary	Number of awakenings	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	pre- to post-treatment 2 months, pre- to post-follow-up 5 months
Secondary	Fatigue Severity Scale (FSS)	Disorder non-specific 7-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 7 to 49. A higher score reflects a higher level of fatigue	pre- to post-treatment 2 months, pre- to post-follow-up 5 months
Secondary	Short-form survey (SF-12 version 1.0)	Non-specific generic scale assessing the quality of life using eight subscales (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health). The score is calculated as a mental component score (MCS-12) and a physical component score (PCS-12) differences compared to the population average, measured in standard deviations. The referent PCS-12 and MCS-12 are both 50 points. The more the deviation is the worse is the quality of life	pre- to post-treatment 2 months, pre- to post-follow-up 5 months
Secondary	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.	pre- to post-treatment 2 months, pre- to post-follow-up 5 months
Secondary	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	pre- to post-treatment 2 months, pre- to post-follow-up 5 months
Secondary	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	pre- to post-treatment 2 months, pre- to post-follow-up 5 months
Secondary	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	pre- to post-treatment 2 months, pre- to post-follow-up 5 months
Secondary	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 64. 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	pre- to post-treatment 2 months, pre- to post-follow-up 5 months
Secondary	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 .86	pre- to post-treatment 2 months, pre- to post-follow-up 5 months
Secondary	Personality Inventory for DSM-5 faceted brief form (PID-5-FBF)	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). Items of the test are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true).; Data from this questionnaire will be used in the analysis of outcome predictors	Once at baseline assessment
Secondary	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	pre- to post-treatment 2 months, pre- to post-follow-up 5 months
Secondary	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	pre- to post-treatment 2 months, pre- to post-follow-up 5 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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