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

Last updated: April 14, 2025
Sponsor: University of Arizona
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Telehealth Cognitive Behavioral Therapy for Insomnia

In-Person Cognitive Behavioral Therapy for Insomnia

Internet Cognitive Behavioral Therapy for Insomnia

Clinical Study ID

NCT05226585
2107024013
  • Ages 50-65
  • All Genders

Study 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 treatment change in sleep, circadian rhythms, biomarkers, cognitive performance, and structural and functional magnetic resonance imaging scans (MRI).

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

Total Participants: 93
Treatment Group(s): 3
Primary Treatment: Telehealth Cognitive Behavioral Therapy for Insomnia
Phase:
Study Start date:
September 26, 2021
Estimated Completion Date:
December 17, 2024

Study 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 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

Connect with a study center

  • The University of Arizona

    Tucson, Arizona 85721
    United States

    Site Not Available

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