Clinical trial NCT04300218: Effectiveness and Cost-effectiveness of iCBT-I in Clinical Settings
Official title: Effectiveness and Cost-effectiveness of iCBT-I in Clinical Settings
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Insomnia
Keywords: cognitive-behavioral psychotherapy
online Intervention
cost-effectiveness
chronic insomnia
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2020-03-09
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter parallel-group add-on superiority randomized controlled trial (RCT) comparing an active treatment condition (iCBT-I plus CAU) to CAU alone
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: pre- to post-treatment 2 months, pre- to post-follow-up 5 months
Secondary outcomes:
measure: Sleep onset latency (SOL),
timeFrame: pre- to post-treatment 2 months, pre- to post-follow-up 5 months
measure: Total sleep time (TST)
timeFrame: pre- to post-treatment 2 months, pre- to post-follow-up 5 months
measure: Sleep efficiency (SE)
timeFrame: pre- to post-treatment 2 months, pre- to post-follow-up 5 months
measure: Wake after sleep onset (WASO)
timeFrame: pre- to post-treatment 2 months, pre- to post-follow-up 5 months
measure: Number of awakenings
timeFrame: pre- to post-treatment 2 months, pre- to post-follow-up 5 months
measure: Fatigue Severity Scale (FSS)
timeFrame: pre- to post-treatment 2 months, pre- to post-follow-up 5 months
measure: Short-form survey (SF-12 version 1.0)
timeFrame: pre- to post-treatment 2 months, pre- to post-follow-up 5 months
measure: Epworth Sleepiness Scale (ESS)
timeFrame: pre- to post-treatment 2 months, pre- to post-follow-up 5 months
measure: Beck Anxiety Inventory (BAI)
timeFrame: pre- to post-treatment 2 months, pre- to post-follow-up 5 months
measure: Beck Depression Inventory (BDI-II)
timeFrame: pre- to post-treatment 2 months, pre- to post-follow-up 5 months
measure: Sleep Hygiene Index (SHI)
timeFrame: pre- to post-treatment 2 months, pre- to post-follow-up 5 months
measure: Sleep Locus of Control Questionnaire (SLC)
timeFrame: pre- to post-treatment 2 months, pre- to post-follow-up 5 months
measure: Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS)
timeFrame: pre- to post-treatment 2 months, pre- to post-follow-up 5 months
measure: Personality Inventory for DSM-5 faceted brief form (PID-5-FBF)
timeFrame: Once at baseline assessment
measure: Trimbos Questionnaire for Costs associated with Psychiatric illness (TiC-P) Health care consumption
timeFrame: pre- to post-treatment 2 months, pre- to post-follow-up 5 months
measure: Trimbos Questionnaire for Costs associated with Psychiatric illness (TiC-P) short Form- Health and Labour Questionnaire (SF-HLQ)
timeFrame: pre- to post-treatment 2 months, pre- to post-follow-up 5 months
measure: Success expectancy
timeFrame: Once at baseline assessment
measure: User satisfaction
timeFrame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
measure: System Usability Scale (SUS)
timeFrame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
measure: Number of completed modules
timeFrame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
measure: Total time spent on the iCBT-I website
timeFrame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
measure: Time spent on each module
timeFrame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
measure: Number of completed sleep diaries
timeFrame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
measure: Usage of the support
timeFrame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
Other outcomes:
Locations:
city: Stavropol
country: Russian Federation
facility: Stavropol regional somnological center
state: Stavropol Region
city: Kemerovo
country: Russian Federation
facility: Kuzbass clinical veterans hospital
city: Moscow
country: Russian Federation
facility: Sleep medicine department, University clinical hospital 3, I.M.Sechenov First Moscow Medical University
Study officials:
affiliation: I.M.Sechenov First Moscow Medical University
name: Mikhail G Poluektov, PhD
role: PRINCIPAL_INVESTIGATOR
References: