Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi)
NCT ID: NCT05226585
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
93 participants
INTERVENTIONAL
2021-09-26
2024-12-17
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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In-person CBTi
CBTi of variable treatment length will be administered by trained study staff in-person.
In-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.
Telehealth CBTi
CBTi of variable treatment length will be administered by trained study staff via HIPAA-compliant tele-video conference.
Telehealth 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.
Internet CBTi
Self-paced CBTi of variable treatment length will be administered via Sleep Healthy Using The Internet (SHUTi).
Internet 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.
Waitlist Control
Treatment will be postponed by 12 weeks.
No interventions assigned to this group
Interventions
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In-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.
Telehealth 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.
Internet 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 \[e.g., fMRI and Neuropsych\])
50 Years
65 Years
ALL
No
Sponsors
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University of Arizona
OTHER
Responsible Party
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Principal Investigators
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Daniel J Taylor, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The University of Arizona
Locations
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The University of Arizona
Tucson, Arizona, United States
Countries
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Other Identifiers
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2107024013
Identifier Type: -
Identifier Source: org_study_id
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