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

Sleep Initiation and Maintenance Disorders Clinical Trial

— CBTi  

Official title:

Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi): A Randomized Controlled Pilot Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05226585
• Other study ID #: 2107024013
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University of Arizona
• Contact: Ethan Olson
• Phone: 520-621-8366
• Email: ethanadamolson[@]arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• 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])

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• In-Person Cognitive Behavioral Therapy for Insomnia
Cognitive behavioral therapy is recommended as a first-line treatment for insomnia (CBTi). CBTi contains the following well-validated components of cognitive behavioral treatment for insomnia: stimulus control, sleep compression, sleep hygiene, relaxation training, and cognitive restructuring.
• Telehealth Cognitive Behavioral Therapy for Insomnia
Telehealth cognitive behavioral therapy is recommended as a first-line treatment for insomnia (CBTi) conducted via audio-video communication. tCBTi contains the following well-validated components of cognitive-behavioral treatment for insomnia: stimulus control, sleep compression, sleep hygiene, relaxation training, and cognitive restructuring.
• Internet Cognitive Behavioral Therapy for Insomnia
Sleep Healthy Using The Internet (SHUTi; aka iCBTi) is a self-guided, fully automated, online CBTi program that includes interactive features: personalized goal setting, graphical feedback based on inputted data, animations/illustrations to enhance comprehension, patient vignettes, and video-based expert explanations.

Locations

Country	Name	City	State
United States	The University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

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