Sleep Initiation and Maintenance Disorders
Conditions
Keywords
insomnia, insomnia disorder, cognitive behavioral therapy
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
Interventions
BEHAVIORALIn-Person Cognitive Behavioral Therapy for Insomnia
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.
BEHAVIORALTelehealth Cognitive Behavioral Therapy for Insomnia
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.
BEHAVIORALInternet Cognitive Behavioral Therapy for Insomnia
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.
Sponsors
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The participant and outcomes assessor will not be aware of participant study conditions.
Intervention model description
Three treatment arms and a waitlist control
Eligibility
Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No
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 \[e.g., fMRI and Neuropsych\])
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index | Pre-treatment | Self-reported severity of insomnia symptoms is assessed once at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diary-assessed Sleep | Pre-treatment | Self-reported severity of sleep parameters (e.g., sleep efficiency, total sleep time, total time in bed). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Health | 12 week Pre-treatment | Cytokines (e.g., IL-6, IL-10, TNFalpha, GFAP, Tau, NFL, UCHL1) |
| Circadian Rhythm | Pre-treatment | Circadian rhythms as assessed by core body temperature |
| Evaluation of episodic memory | Pre-treatment | Neuropsychological tests of episodic memory using a program administered via iPad |
| Evaluation of executive functioning | Pre-treatment | Neuropsychological tests of executive functioning using a program administered via iPad |
| Magnetic resonance imaging (MRI) | Pre-treatment | Neurological outcomes (e.g., MRI resting-state functional connectivity: cingulate cortex, left insula, left cuneus, and fusiform; salience, executive control, and default mode networks.) |
Countries
United States
Outcome results
None listed