Sleep Initiation and Maintenance Disorders Clinical Trial
— CBTiOfficial title:
Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi): A Randomized Controlled Pilot Trial
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).
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2024 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 65 Years |
Eligibility | 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]) |
Country | Name | City | State |
---|---|---|---|
United States | The University of Arizona | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
University of Arizona |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Circadian Rhythm | Circadian rhythms as assessed by core body temperature | Pre-treatment | |
Other | Circadian Rhythm | Circadian rhythms as assessed by core body temperature | 12 week Post-treatment | |
Other | Magnetic resonance imaging (MRI) | Neurological outcomes (e.g., MRI resting-state functional connectivity: cingulate cortex, left insula, left cuneus, and fusiform; salience, executive control, and default mode networks.) | Pre-treatment | |
Other | Magnetic resonance imaging (MRI) | Neurological outcomes (e.g., MRI resting-state functional connectivity: cingulate cortex, left insula, left cuneus, and fusiform; salience, executive control, and default mode networks.) | 12 week Post-treatment | |
Other | Inflammatory Health | Cytokines (e.g., IL-6, IL-10, TNFalpha, GFAP, Tau, NFL, UCHL1) | 12 week Pre-treatment | |
Other | Inflammatory Health | Cytokines (e.g., IL-6, IL-10, TNFalpha, GFAP, Tau, NFL, UCHL1) | 12 week Post-treatment | |
Other | Evaluation of executive functioning | Neuropsychological tests of executive functioning using a program administered via iPad | Pre-treatment | |
Other | Evaluation of episodic memory | Neuropsychological tests of episodic memory using a program administered via iPad | Pre-treatment | |
Other | Evaluation of executive functioning | Neuropsychological tests of executive functioning using a program administered via iPad. Due to the nature of these assessments, specific details of the tests cannot be disclosed. | 12 week Post-treatment | |
Other | Evaluation of episodic memory | Neuropsychological tests of episodic memory using a program administered via iPad. Due to the nature of these assessments, specific details of the tests cannot be disclosed. | 12 week Post-treatment | |
Primary | Insomnia Severity Index | Self-reported severity of insomnia symptoms is assessed once at baseline. | Pre-treatment | |
Primary | Insomnia Severity Index | Self-reported severity of insomnia symptoms is assessed weekly through the duration of treatment. | During treatment | |
Primary | Insomnia Severity Index | Self-reported severity of insomnia symptoms is assessed once at posttreatment. | 12-week Post-treatment | |
Secondary | Diary-assessed Sleep | Self-reported severity of sleep parameters (e.g., sleep efficiency, total sleep time, total time in bed). | Pre-treatment | |
Secondary | Diary-assessed Sleep | Self-reported severity of sleep parameters (e.g., sleep efficiency, total sleep time, total time in bed). | During treatment | |
Secondary | Diary-assessed Sleep | Self-reported severity of sleep parameters (e.g., sleep efficiency, total sleep time, total time in bed). | 12 week Post-treatment |
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