Tailoring an Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic Diseases (REPOSE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic Diseass

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deborah Da Costa, PhD; Phone Number: 44725 514-934-1934; Email: deborah.dacosta@mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Internet delivered Cognitive Behaviour Therapy for Insomnia 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.	Behavioral: Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic Diseass; 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.
Other: Arm 2: Wait list Control Group; 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.	Behavioral: Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic Diseass; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Enrollement to 3 months post treatment

Collaborators and Investigators

• Sponsor: McGill University
• Investigators: Principal Investigator: Deborah Da Costa, PhD, McGill University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: November 3, 2024
• First Posted (Estimated): November 5, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 3, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Mental Disorders; Connective Tissue Diseases; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: 2021-6547

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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