Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi) (CBTi)

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  • sponsor
    University of Arizona
Updated on 14 March 2022
behavior therapy
cognitive behavioral therapy for insomnia


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).


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

Condition Sleep Initiation and Maintenance Disorders
Treatment In-Person Cognitive Behavioral Therapy for Insomnia, Telehealth Cognitive Behavioral Therapy for Insomnia, Internet Cognitive Behavioral Therapy for Insomnia
Clinical Study IdentifierNCT05226585
SponsorUniversity of Arizona
Last Modified on14 March 2022


Yes No Not Sure

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])
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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