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

NCT06674317 | Not Yet Recruiting

• 1 other identifier: 2021-6547
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

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.

Behavioral: Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic Diseass

Interventions

Internet Delivered Cognitive Behavioral Therapy for Insomnia in Persons with Inflammatory Rheumatic Diseass BEHAVIORAL

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.

Arm 1: Internet delivered Cognitive Behaviour Therapy for Insomnia group; Arm 2: Wait list Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) )

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Deborah Da Costa, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah Da Costa, PhD

CONTACT

514-934-1934; deborah.dacosta@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deborah Da Costa, PhD, Associate Professor, Department of Medicine, McGill University; Scientist, RI-MUHC

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 5, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share