Phase
Condition
N/ATreatment
Telehealth Cognitive Behavioral Therapy for Insomnia
In-Person Cognitive Behavioral Therapy for Insomnia
Internet Cognitive Behavioral Therapy for Insomnia
Clinical Study ID
Ages 50-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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) orSHUTi (for iCBTi group)
MoCA scores ≥24 will be deemed normal cognitive status and considered eligible forstudy participation and/or assessed by the ability to comprehend the baselinescreening questionnaires
Willing to refrain from new external behavioral health or medication treatment forissues pertaining to sleep during participation in the study
Indication that the individual plans to be in the area for the 6 months followingthe first baseline assessment
Exclusion
Exclusion Criteria:
Failure to meet the above "inclusion criteria"
Current circadian rhythm disorder, sleep deprivation, or hypersomnia and relatedsleep disorders (assessed with clinical interview and/or self-report) as CBTi hasnot been validated in these populations. Verified by self-report and/or clinicalinterview (SCISD-R)
Untreated sleep disordered breathing (e.g., obstructive sleep apnea) assessed byself-report, clinical interview, and/or diagnostic sleep study (i.e., baseline sleepstudy PSG)
Failing to meet criteria for MRI scan (e.g., having metallic implants); seePre-screen MRI Checklist for full list of exclusions for MRI scans.
Fear/phobia of needles (conflict with blood draw) and/or small spaces (conflict withMRI scanner)
Current suicide risk meriting crisis intervention as assessed by the Patient HealthQuestionnaire (PHQ-9) and/or disclosure of serious suicidal ideation
Pregnancy (self-report, proposed instruments and treatments have not been validatedin this population)
Sleep efficiency > 85%, assessed by the sleep diary
Serious mental health diagnosis (e.g., bipolar disorder or psychosis) assessed bystructured interview (M.I.N.I.)
Currently engaged in evidence-based psychotherapy for Insomnia (i.e., CognitiveBehavioral Therapy) by self-report
Failure to follow protocol (e.g., consistent "no show" for appointments, answeringquestionnaires dishonestly, refusal to complete more than 2 assessments [e.g., fMRIand Neuropsych])
Study Design
Study Description
Connect with a study center
The University of Arizona
Tucson, Arizona 85721
United StatesSite Not Available
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