Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi)
- Conditions
- Sleep Initiation and Maintenance Disorders
- Interventions
- Behavioral: In-Person Cognitive Behavioral Therapy for InsomniaBehavioral: Telehealth Cognitive Behavioral Therapy for InsomniaBehavioral: Internet Cognitive Behavioral Therapy for Insomnia
- Registration Number
- NCT05226585
- Lead Sponsor
- University of Arizona
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
- 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
- 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])
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description In-person CBTi In-Person Cognitive Behavioral Therapy for Insomnia CBTi of variable treatment length will be administered by trained study staff in-person. Telehealth CBTi Telehealth Cognitive Behavioral Therapy for Insomnia CBTi of variable treatment length will be administered by trained study staff via HIPAA-compliant tele-video conference. Internet CBTi Internet Cognitive Behavioral Therapy for Insomnia Self-paced CBTi of variable treatment length will be administered via Sleep Healthy Using The Internet (SHUTi).
- Primary Outcome Measures
Name Time Method Insomnia Severity Index 12-week Post-treatment Self-reported severity of insomnia symptoms is assessed once at posttreatment.
- Secondary Outcome Measures
Name Time Method Diary-assessed Sleep 12 week Post-treatment Self-reported severity of sleep parameters (e.g., sleep efficiency, total sleep time, total time in bed).
Trial Locations
- Locations (1)
The University of Arizona
🇺🇸Tucson, Arizona, United States