search
Back to results

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

Primary Purpose

Sleep Initiation and Maintenance Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-Person Cognitive Behavioral Therapy for Insomnia
Telehealth Cognitive Behavioral Therapy for Insomnia
Internet Cognitive Behavioral Therapy for Insomnia
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring insomnia, insomnia disorder, cognitive behavioral therapy

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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])

Sites / Locations

  • The University of ArizonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

In-person CBTi

Telehealth CBTi

Internet CBTi

Waitlist Control

Arm Description

CBTi of variable treatment length will be administered by trained study staff in-person.

CBTi of variable treatment length will be administered by trained study staff via HIPAA-compliant tele-video conference.

Self-paced CBTi of variable treatment length will be administered via Sleep Healthy Using The Internet (SHUTi).

Treatment will be postponed by 12 weeks.

Outcomes

Primary Outcome Measures

Insomnia Severity Index
Self-reported severity of insomnia symptoms is assessed once at baseline.
Insomnia Severity Index
Self-reported severity of insomnia symptoms is assessed weekly through the duration of treatment.
Insomnia Severity Index
Self-reported severity of insomnia symptoms is assessed once at posttreatment.

Secondary Outcome Measures

Diary-assessed Sleep
Self-reported severity of sleep parameters (e.g., sleep efficiency, total sleep time, total time in bed).
Diary-assessed Sleep
Self-reported severity of sleep parameters (e.g., sleep efficiency, total sleep time, total time in bed).
Diary-assessed Sleep
Self-reported severity of sleep parameters (e.g., sleep efficiency, total sleep time, total time in bed).

Full Information

First Posted
September 28, 2021
Last Updated
May 8, 2023
Sponsor
University of Arizona
search

1. Study Identification

Unique Protocol Identification Number
NCT05226585
Brief Title
Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi)
Acronym
CBTi
Official Title
Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi): A Randomized Controlled Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders
Keywords
insomnia, insomnia disorder, cognitive behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three treatment arms and a waitlist control
Masking
ParticipantOutcomes Assessor
Masking Description
The participant and outcomes assessor will not be aware of participant study conditions.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
In-person CBTi
Arm Type
Active Comparator
Arm Description
CBTi of variable treatment length will be administered by trained study staff in-person.
Arm Title
Telehealth CBTi
Arm Type
Active Comparator
Arm Description
CBTi of variable treatment length will be administered by trained study staff via HIPAA-compliant tele-video conference.
Arm Title
Internet CBTi
Arm Type
Active Comparator
Arm Description
Self-paced CBTi of variable treatment length will be administered via Sleep Healthy Using The Internet (SHUTi).
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
Treatment will be postponed by 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
In-Person Cognitive Behavioral Therapy for Insomnia
Other Intervention Name(s)
CBTi
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telehealth Cognitive Behavioral Therapy for Insomnia
Other Intervention Name(s)
tCBTi
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet Cognitive Behavioral Therapy for Insomnia
Other Intervention Name(s)
iCBTi
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insomnia Severity Index
Description
Self-reported severity of insomnia symptoms is assessed once at baseline.
Time Frame
Pre-treatment
Title
Insomnia Severity Index
Description
Self-reported severity of insomnia symptoms is assessed weekly through the duration of treatment.
Time Frame
During treatment
Title
Insomnia Severity Index
Description
Self-reported severity of insomnia symptoms is assessed once at posttreatment.
Time Frame
12-week Post-treatment
Secondary Outcome Measure Information:
Title
Diary-assessed Sleep
Description
Self-reported severity of sleep parameters (e.g., sleep efficiency, total sleep time, total time in bed).
Time Frame
Pre-treatment
Title
Diary-assessed Sleep
Description
Self-reported severity of sleep parameters (e.g., sleep efficiency, total sleep time, total time in bed).
Time Frame
During treatment
Title
Diary-assessed Sleep
Description
Self-reported severity of sleep parameters (e.g., sleep efficiency, total sleep time, total time in bed).
Time Frame
12 week Post-treatment
Other Pre-specified Outcome Measures:
Title
Circadian Rhythm
Description
Circadian rhythms as assessed by core body temperature
Time Frame
Pre-treatment
Title
Circadian Rhythm
Description
Circadian rhythms as assessed by core body temperature
Time Frame
12 week Post-treatment
Title
Magnetic resonance imaging (MRI)
Description
Neurological outcomes (e.g., MRI resting-state functional connectivity: cingulate cortex, left insula, left cuneus, and fusiform; salience, executive control, and default mode networks.)
Time Frame
Pre-treatment
Title
Magnetic resonance imaging (MRI)
Description
Neurological outcomes (e.g., MRI resting-state functional connectivity: cingulate cortex, left insula, left cuneus, and fusiform; salience, executive control, and default mode networks.)
Time Frame
12 week Post-treatment
Title
Inflammatory Health
Description
Cytokines (e.g., IL-6, IL-10, TNFalpha, GFAP, Tau, NFL, UCHL1)
Time Frame
12 week Pre-treatment
Title
Inflammatory Health
Description
Cytokines (e.g., IL-6, IL-10, TNFalpha, GFAP, Tau, NFL, UCHL1)
Time Frame
12 week Post-treatment
Title
Evaluation of executive functioning
Description
Neuropsychological tests of executive functioning using a program administered via iPad
Time Frame
Pre-treatment
Title
Evaluation of episodic memory
Description
Neuropsychological tests of episodic memory using a program administered via iPad
Time Frame
Pre-treatment
Title
Evaluation of executive functioning
Description
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.
Time Frame
12 week Post-treatment
Title
Evaluation of episodic memory
Description
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.
Time Frame
12 week Post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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])
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ethan Olson
Phone
520-621-8366
Email
ethanadamolson@arizona.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alisa Huskey, Ph.D.
Phone
520-621-8366
Email
ahuskey@arizona.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J Taylor, Ph.D.
Organizational Affiliation
The University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ethan Olson
Phone
520-621-8366
Email
ethanadamolson@email.arizona.edu
First Name & Middle Initial & Last Name & Degree
Alisa M Huskey, Ph.D.
Phone
520-621-8366
Email
ahuskey@email.arizona.edu
First Name & Middle Initial & Last Name & Degree
Daniel J Taylor, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs