Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi)

Study Overview
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Brief Summary
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The purpose of this study is to investigate the mechanisms of change in Cognitive Behavioral Therapy for insomnia (CBTi) in a sample of adults aged 50-65. This study aims to evaluate the pre-post treatment change in sleep, circadian rhythms, biomarkers, cognitive performance, and structural and functional magnetic resonance imaging scans (MRI).

Detailed Description
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Baseline Part 1: Online demographic and contact information Schedule Baseline Part 2 with the investigators via online link 1 week of daily sleep diaries Baseline Part 2: Internet-based interview with the investigators to confirm study eligibility requirements Online self-report questionnaires 2 weeks of daily sleep diaries 2 weeks of sleep/wake assessment wearing a watch-like activity monitor (Actiwatch) Objective Baseline: Single-night, diagnostic in-home sleep study, including and the following equipment: Adhesive patch which will adhere to the arm Sensor belts worn around the chest, fitted with nasal canula, pulse oximeter, and 3 electrodes which will adhere to the back of the neck and behind each ear Next-day appointment: Neuropsychological assessment Structural and functional magnetic resonance imaging scan (MRI) Non-invasive blood pressure readings Low-volume Blood draw (used to obtain genetic biomarkers) Removal of adhesive patch Next-day evening (2-nights): Consumable capsule Sensor belt worn around the chest/abdomen Random Assignment: If it is determined the participant is eligible for the study, participants will be randomly assigned to one of the treatment groups (in-person, telehealth or internet delivered) or asked to wait to start treatment. Treatment Phase I: Participants will complete up to 12 weeks of insomnia treatment or wait for treatment (waitlist) 12-Week Post-treatment Part 1: Complete 2 weeks of an online daily sleep diary and actigraphy Complete online self-report questionnaires Objective 12-Week Post-treatment: • Repeat Objective Baseline outlined above Treatment Phase II (WLC): Treatment will start for participants who had been assigned to the waitlist condition 3-Month Follow-Up: Complete online self-report questionnaires

Official Title
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Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi): A Randomized Controlled Pilot Trial

Conditions
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Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Behavioral: In-Person Cognitive Behavioral Therapy for Insomnia
* Behavioral: Telehealth Cognitive Behavioral Therapy for Insomnia
* Behavioral: Internet Cognitive Behavioral Therapy for Insomnia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 50-65 Normal hearing with or without hearing aids Ability to speak and read English and ability to give informed consent Possession of a computer with video and audio capabilities Meets DSM-5 Criteria for Insomnia Disorder Internet speed sufficient for participating in teletherapy (e.g., Zoom Health) or SHUTi (for iCBTi group) MoCA scores ≥24 will be deemed normal cognitive status and considered eligible for study participation and/or assessed by the ability to comprehend the baseline screening questionnaires Willing to refrain from new external behavioral health or medication treatment for issues pertaining to sleep during participation in the study Indication that the individual plans to be in the area for the 6 months following the first baseline assessment Exclusion Criteria: Failure to meet the above inclusion criteria Current circadian rhythm disorder, sleep deprivation, or hypersomnia and related sleep disorders (assessed with clinical interview and/or self-report) as CBTi has not been validated in these populations. Verified by self-report and/or clinical interview (SCISD-R) Untreated sleep disordered breathing (e.g., obstructive sleep apnea) assessed by self-report, clinical interview, and/or diagnostic sleep study (i.e., baseline sleep study PSG) Failing to meet criteria for MRI scan (e.g., having metallic implants); see Pre-screen MRI Checklist for full list of exclusions for MRI scans. Fear/phobia of needles (conflict with blood draw) and/or small spaces (conflict with MRI scanner) Current suicide risk meriting crisis intervention as assessed by the Patient Health Questionnaire (PHQ-9) and/or disclosure of serious suicidal ideation Pregnancy (self-report, proposed instruments and treatments have not been validated in this population) Sleep efficiency > 85%, assessed by the sleep diary Serious mental health diagnosis (e.g., bipolar disorder or psychosis) assessed by structured interview (M.I.N.I.) Currently engaged in evidence-based psychotherapy for Insomnia (i.e., Cognitive Behavioral Therapy) by self-report Failure to follow protocol (e.g., consistent no show for appointments, answering questionnaires dishonestly, refusal to complete more than 2 assessments [e.g., fMRI and Neuropsych])

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three treatment arms and a waitlist control
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-person CBTi<br>CBTi of variable treatment length will be administered by trained study staff in-person. | Behavioral: In-Person Cognitive Behavioral Therapy for Insomnia<br>* Cognitive behavioral therapy is recommended as a first-line treatment for insomnia (CBTi). CBTi contains the following well-validated components of cognitive behavioral treatment for insomnia: stimulus control, sleep compression, sleep hygiene, relaxation training, and cognitive restructuring.<br>* Other names: CBTi;|
| Active Comparator: Telehealth CBTi<br>CBTi of variable treatment length will be administered by trained study staff via HIPAA-compliant tele-video conference. | Behavioral: Telehealth Cognitive Behavioral Therapy for Insomnia<br>* Telehealth cognitive behavioral therapy is recommended as a first-line treatment for insomnia (CBTi) conducted via audio-video communication. tCBTi contains the following well-validated components of cognitive-behavioral treatment for insomnia: stimulus control, sleep compression, sleep hygiene, relaxation training, and cognitive restructuring.<br>* Other names: tCBTi;|
| Active Comparator: Internet CBTi<br>Self-paced CBTi of variable treatment length will be administered via Sleep Healthy Using The Internet (SHUTi). | Behavioral: Internet Cognitive Behavioral Therapy for Insomnia<br>* Sleep Healthy Using The Internet (SHUTi; aka iCBTi) is a self-guided, fully automated, online CBTi program that includes interactive features: personalized goal setting, graphical feedback based on inputted data, animations/illustrations to enhance comprehension, patient vignettes, and video-based expert explanations.<br>* Other names: iCBTi;|
| No Intervention: Waitlist Control<br>Treatment will be postponed by 12 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index | Self-reported severity of insomnia symptoms is assessed once at baseline. | Pre-treatment | 
| Insomnia Severity Index | Self-reported severity of insomnia symptoms is assessed weekly through the duration of treatment. | During treatment | 
| Insomnia Severity Index | Self-reported severity of insomnia symptoms is assessed once at posttreatment. | 12-week Post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diary-assessed Sleep | Self-reported severity of sleep parameters (e.g., sleep efficiency, total sleep time, total time in bed). | Pre-treatment | 
| Diary-assessed Sleep | Self-reported severity of sleep parameters (e.g., sleep efficiency, total sleep time, total time in bed). | During treatment | 
| Diary-assessed Sleep | Self-reported severity of sleep parameters (e.g., sleep efficiency, total sleep time, total time in bed). | 12 week Post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insomnia, insomnia disorder, cognitive behavioral therapy