Status:
COMPLETED
Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi)
Lead Sponsor:
University of Arizona
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
50-65 years
Phase:
NA
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 trea...
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 int...
Eligibility Criteria
Inclusion
- 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
- 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 \[e.g., fMRI and Neuropsych\])
Key Trial Info
Start Date :
September 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2024
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT05226585
Start Date
September 26 2021
End Date
December 17 2024
Last Update
April 16 2025
Active Locations (1)
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1
The University of Arizona
Tucson, Arizona, United States, 85721