Sleep Initiation and Maintenance DisordersCBTiNCT05226585
Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi)
A study testing In-Person Cognitive Behavioral Therapy for Insomnia, Telehealth Cognitive Behavioral Therapy for Insomnia and Internet Cognitive Behavioral Therapy for Insomnia in people with Sleep Initiation and Maintenance Disorders, run by University of Arizona at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- In-Person Cognitive Behavioral Therapy for Insomnia, Telehealth Cognitive Behavioral Therapy for Insomnia and Internet Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2021to 17 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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])
Trial locations and contacts
1 site in 1 country.
About this study
Official 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).
Read the 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
- Being tested
- In-Person Cognitive Behavioral Therapy for Insomnia, Telehealth Cognitive Behavioral Therapy for Insomnia, Internet Cognitive Behavioral Therapy for Insomnia
- Keywords
- insomnia, insomnia disorder, cognitive behavioral therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Person Cognitive Behavioral Therapy for InsomniaBehavioural
Also called CBTi
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 InsomniaBehavioural
Also called tCBTi
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 InsomniaBehavioural
Also called iCBTi
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.
| Study group | Role | What they receive |
|---|---|---|
| In-person CBTi | Active comparator | CBTi of variable treatment length will be administered by trained study staff in-person. Receives: Behavioral: In-Person Cognitive Behavioral Therapy for Insomnia |
| Telehealth CBTi | Active comparator | CBTi of variable treatment length will be administered by trained study staff via HIPAA-compliant tele-video conference. Receives: Behavioral: Telehealth Cognitive Behavioral Therapy for Insomnia |
| Internet CBTi | Active comparator | Self-paced CBTi of variable treatment length will be administered via Sleep Healthy Using The Internet (SHUTi). Receives: Behavioral: Internet Cognitive Behavioral Therapy for Insomnia |
| Waitlist Control | No intervention | Treatment will be postponed by 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
Self-reported severity of insomnia symptoms is assessed once at baseline.
Measured: Pre-treatment
Insomnia Severity Index
Self-reported severity of insomnia symptoms is assessed weekly through the duration of treatment.
Measured: During treatment
Insomnia Severity Index
Self-reported severity of insomnia symptoms is assessed once at posttreatment.
Measured: 12-week Post-treatment
Secondary outcomes (3)
Diary-assessed Sleep
Self-reported severity of sleep parameters (e.g., sleep efficiency, total sleep time, total time in bed).
Measured: Pre-treatment
Diary-assessed Sleep
Self-reported severity of sleep parameters (e.g., sleep efficiency, total sleep time, total time in bed).
Measured: During treatment
Diary-assessed Sleep
Self-reported severity of sleep parameters (e.g., sleep efficiency, total sleep time, total time in bed).
Measured: 12 week Post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start26 Sep 2021
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three treatment arms and a waitlist control
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel J Taylor, Ph.D., Principal investigator, The University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226585
- Sponsor's protocol ID
- 2107024013
- Acronym
- CBTi
- Status last verified
- May 2024
- First submitted
- 28 Sep 2021
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi): A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT05226585
- Acronym / sponsor ID
- CBTi / 2107024013
- Keywords
- insomnia, insomnia disorder, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 26 Sep 2021 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Three treatment arms and a waitlist control
| Arm | Type | Receives |
|---|---|---|
| In-person CBTi | Active comparator | Behavioral: In-Person Cognitive Behavioral Therapy for InsomniaCBTi of variable treatment length will be administered by trained study staff in-person. |
| Telehealth CBTi | Active comparator | Behavioral: Telehealth Cognitive Behavioral Therapy for InsomniaCBTi of variable treatment length will be administered by trained study staff via HIPAA-compliant tele-video conference. |
| Internet CBTi | Active comparator | Behavioral: Internet Cognitive Behavioral Therapy for InsomniaSelf-paced CBTi of variable treatment length will be administered via Sleep Healthy Using The Internet (SHUTi). |
| Waitlist Control | No intervention | –Treatment will be postponed by 12 weeks. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-Person Cognitive Behavioral Therapy for InsomniaAlso: CBTiCognitive 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. | Behavioural | In-person CBTi |
| Telehealth Cognitive Behavioral Therapy for InsomniaAlso: tCBTiTelehealth 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. | Behavioural | Telehealth CBTi |
| Internet Cognitive Behavioral Therapy for InsomniaAlso: iCBTiSleep 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. | Behavioural | Internet CBTi |
Primary outcome
Insomnia Severity Index
Time frame: Pre-treatment
Self-reported severity of insomnia symptoms is assessed once at baseline.
Insomnia Severity Index
Time frame: During treatment
Self-reported severity of insomnia symptoms is assessed weekly through the duration of treatment.
Insomnia Severity Index
Time frame: 12-week Post-treatment
Self-reported severity of insomnia symptoms is assessed once at posttreatment.
3 secondary outcomes
Diary-assessed Sleep
Time frame: Pre-treatment
Diary-assessed Sleep
Time frame: During treatment
Diary-assessed Sleep
Time frame: 12 week Post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J Taylor, Ph.D. principal investigator
The University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-Person Cognitive Behavioral Therapy for Insomnia, Telehealth Cognitive Behavioral Therapy for Insomnia and Internet Cognitive Behavioral Therapy for Insomnia in people with Sleep Initiation and Maintenance Disorders, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: Pre-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.