InsomniaREPOSENCT06674317
Tailoring an Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic Diseases
A study testing Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic Diseass in people with Insomnia, run by McGill University.
Trial summary
Cognitive behavioral therapy for insomnia (CBTi) is considered a first-line treatment for insomnia. Access to this treatment option is limited therefore the investigators have been developing an internet delivered cognitive behavioral therapy for insomnia (I-CBTi) to help overcome accessibility barriers. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic Diseass
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported physician diagnosis of one or more of the following Inflammatory Rheumatic Diseases: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or other spondyloarthropathies, systemic lupus erythematosus
- Have an e-mail address and internet access
- Speak and read English or French
- Resident of Canada and living in Canada for the duration of the trial
- Have insomnia symptoms ( score ≥8 on the Insomnia Severity Index (ISI) )
Who cannot join
- Self-reported sleep disorder diagnosed by a physician other than insomnia (e.g. obstructive sleep apnea)
- Severe psychiatric disorder (e.g. schizophrenia, bipolar disorder) or neurological disorders (e.g diagnosis of dementia, Parkinson disease, epilepsy)
- Already involved in psychotherapy addressing sleep difficulties
- Shift work in the past 3 months or next 6 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Tailoring an Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic Diseases: Acceptability and Feasibility- Phase 2
Cognitive behavioral therapy for insomnia (CBTi) is considered a first-line treatment for insomnia. Access to this treatment option is limited therefore the investigators have been developing an internet delivered cognitive behavioral therapy for insomnia (I-CBTi) to help overcome accessibility barriers.
The purpose of this study is to pilot test a tailored internet-delivered cognitive behavioral therapy for insomnia (I-CBTi) intervention for persons with Inflammatory Rheumatic Diseases showing symptoms of insomnia.
- Conditions
- Insomnia
- Being tested
- Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic Diseass
- 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.
Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic DiseassBehavioural
Cognitive behavioral therapy for insomnia (CBTi) is considered a first-line treatment for insomnia. Access to this treatment option is limited therefore we have been developing an internet delivered cognitive behavioral therapy for insomnia (I-CBTi) to help overcome accessibility barriers.
The purpose of this study is to pilot test a tailored internet-delivered cognitive behavioral therapy for insomnia (I-CBTi) intervention for persons with Inflammatory Rheumatic Diseases showing symptoms of insomnia.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Internet delivered Cognitive Behaviour Therapy for Insomnia group | Experimental | This group you will have access to the internet delivered cognitive behavioral therapy for insomnia intervention following the completion of the first study entry questionnaire. Receives: Behavioral: Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic Diseass |
| Arm 2: Wait list Control Group | Other | This wait list control group will be offered access to the internet delivered cognitive behavioral therapy for insomnia intervention AFTER completion of the third online questionnaires 5 months after group assignment. Receives: Behavioral: Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic Diseass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Acceptability of the Internet Delivered Cognitive Behavioral Therapy for Insomnia (CBTi) Intervention as Assessed by the Treatment Expectancies and Perceived Credibility Questionnaire (TEPCQ)
The Treatment Expectancies and Perceived Credibility Questionnaire (TEPCQ) is a 5-item questionnaire that evaluates participants' therapeutic expectancies and the credibility they give to the treatment proposed.
Measured: At enrollment
Participant Acceptability of the Internet Delivered Cognitive Behavioral Therapy for Insomnia (CBTi) Intervention as Assessed by the Treatment Perception Questionnaire (TPQ)
The Treatment Perception Questionnaire (TPQ) assesses the degree to which participants consulted the written and visual content of each module in the internet delivered Cognitive Behavioral Therapy for Insomnia program, the usefulness of each of the 6 modules, level of satisfaction with the written and video content, as well as the global satisfaction with the intervention.
Measured: From enrollment until 8 weeks post treatment
Change in Sleep Difficulty from Enrollment to 3 Months Post Treatment as Assessed by the Sleep Severity Index (ISI)
The Insomnia Sleep Index is a 7-item self-report questionnaire measuring the perceived severity and difficulties with sleep. The measure yields a total score from 0-28. Scores from 0-7 indicate no insomnia, 8-14 subthreshold insomnia, 15-21 moderate clinical insomnia and 22-28 severe insomnia.
Measured: Enrollement to 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Nov 2024 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: I-CBTi group: This group you will have access to the internet delivered cognitive behavioral therapy for insomnia intervention following the completion of the first study entry questionnaire. Group 2: WLC group: This group will be offered access to the internet delivered cognitive behavioral therapy for insomnia intervention AFTER completion of the third online questionnaires 5 months after group assignment.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Da Costa, McGill University
- Investigators
- Deborah Da Costa, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674317
- Sponsor's protocol ID
- 2021-6547
- Acronym
- REPOSE
- Status last verified
- Nov 2024
- First submitted
- 31 Oct 2024
- Last updated
- 5 Nov 2024
- 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 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailoring an Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic Diseases: Acceptability and Feasibility- Phase 2
- ClinicalTrials.gov ID
- NCT06674317
- Acronym / sponsor ID
- REPOSE / 2021-6547
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 5 Nov 2024 (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.
Cognitive behavioral therapy for insomnia (CBTi) is considered a first-line treatment for insomnia. Access to this treatment option is limited therefore the investigators have been developing an internet delivered cognitive behavioral therapy for insomnia (I-CBTi) to help overcome accessibility barriers.
The purpose of this study is to pilot test a tailored internet-delivered cognitive behavioral therapy for insomnia (I-CBTi) intervention for persons with Inflammatory Rheumatic Diseases showing symptoms of insomnia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1: I-CBTi group: This group you will have access to the internet delivered cognitive behavioral therapy for insomnia intervention following the completion of the first study entry questionnaire. Group 2: WLC group: This group will be offered access to the internet delivered cognitive behavioral therapy for insomnia intervention AFTER completion of the third online questionnaires 5 months after group assignment.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Internet delivered Cognitive Behaviour Therapy for Insomnia group | Experimental | Behavioral: Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic DiseassThis group you will have access to the internet delivered cognitive behavioral therapy for insomnia intervention following the completion of the first study entry questionnaire. |
| Arm 2: Wait list Control Group | Other | Behavioral: Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic DiseassThis wait list control group will be offered access to the internet delivered cognitive behavioral therapy for insomnia intervention AFTER completion of the third online questionnaires 5 months after group assignment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-reported physician diagnosis of one or more of the following Inflammatory Rheumatic Diseases: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or other spondyloarthropathies, systemic lupus erythematosus
- Have an e-mail address and internet access
- Speak and read English or French
- Resident of Canada and living in Canada for the duration of the trial
- Have insomnia symptoms ( score ≥8 on the Insomnia Severity Index (ISI) )
Key exclusion criteria (4 listed)
- Self-reported sleep disorder diagnosed by a physician other than insomnia (e.g. obstructive sleep apnea)
- Severe psychiatric disorder (e.g. schizophrenia, bipolar disorder) or neurological disorders (e.g diagnosis of dementia, Parkinson disease, epilepsy)
- Already involved in psychotherapy addressing sleep difficulties
- Shift work in the past 3 months or next 6 months
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 |
|---|---|---|
| Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic DiseassCognitive behavioral therapy for insomnia (CBTi) is considered a first-line treatment for insomnia. Access to this treatment option is limited therefore we have been developing an internet delivered cognitive behavioral therapy for insomnia (I-CBTi) to help overcome accessibility barriers. The purpose of this study is to pilot test a tailored internet-delivered cognitive behavioral therapy for insomnia (I-CBTi) intervention for persons with Inflammatory Rheumatic Diseases showing symptoms of insomnia. | Behavioural | Arm 1: Internet delivered Cognitive Behaviour Therapy for Insomnia group, Arm 2: Wait list Control Group |
Primary outcome
Participant Acceptability of the Internet Delivered Cognitive Behavioral Therapy for Insomnia (CBTi) Intervention as Assessed by the Treatment Expectancies and Perceived Credibility Questionnaire (TEPCQ)
Time frame: At enrollment
The Treatment Expectancies and Perceived Credibility Questionnaire (TEPCQ) is a 5-item questionnaire that evaluates participants' therapeutic expectancies and the credibility they give to the treatment proposed.
Participant Acceptability of the Internet Delivered Cognitive Behavioral Therapy for Insomnia (CBTi) Intervention as Assessed by the Treatment Perception Questionnaire (TPQ)
Time frame: From enrollment until 8 weeks post treatment
The Treatment Perception Questionnaire (TPQ) assesses the degree to which participants consulted the written and visual content of each module in the internet delivered Cognitive Behavioral Therapy for Insomnia program, the usefulness of each of the 6 modules, level of satisfaction with the written and video content, as well as the global satisfaction with the intervention.
Change in Sleep Difficulty from Enrollment to 3 Months Post Treatment as Assessed by the Sleep Severity Index (ISI)
Time frame: Enrollement to 3 months post treatment
The Insomnia Sleep Index is a 7-item self-report questionnaire measuring the perceived severity and difficulties with sleep. The measure yields a total score from 0-28. Scores from 0-7 indicate no insomnia, 8-14 subthreshold insomnia, 15-21 moderate clinical insomnia and 22-28 severe insomnia.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- 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.
Deborah Da Costa, PhD principal investigator
McGill University
Questions about this trial
What is this clinical trial studying?
A study testing Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic Diseass in people with Insomnia, run by McGill University.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah Da Costa, PhD (514-934-1934 ext. 44725, deborah.dacosta@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Acceptability of the Internet Delivered Cognitive Behavioral Therapy for Insomnia (CBTi) Intervention as Assessed by the Treatment Expectancies and Perceived Credibility Questionnaire (TEPCQ) (time frame: At enrollment). 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 5 Nov 2024.