Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi): A Randomized Controlled Pilot Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sleep Initiation and Maintenance Disorders
- Sponsor
- University of Arizona
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- Insomnia Severity Index
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Insomnia Severity Index
Time Frame: 12-week Post-treatment
Self-reported severity of insomnia symptoms is assessed once at posttreatment.
Secondary Outcomes
- Diary-assessed Sleep(12 week Post-treatment)