Clinical trial NCT06674317: Tailoring an Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic Diseases
Official title: Tailoring an Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic Diseases: Acceptability and Feasibility- Phase 2
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Insomnia
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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) )

Exclusion Criteria:

* 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

Primary outcomes:
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)
timeFrame: At enrollment
measure: Participant Acceptability of the Internet Delivered Cognitive Behavioral Therapy for Insomnia (CBTi) Intervention as Assessed by the Treatment Perception Questionnaire (TPQ)
timeFrame: From enrollment until 8 weeks post treatment
measure: Change in Sleep Difficulty from Enrollment to 3 Months Post Treatment as Assessed by the Sleep Severity Index (ISI)
timeFrame: Enrollement to 3 months post treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: McGill University
name: Deborah Da Costa, PhD
role: PRINCIPAL_INVESTIGATOR
References: