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

N/ANot Yet RecruitingNCT06674317

McGill University52 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Insomnia

Interventions

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

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Enrollement to 3 months post treatment

Central Contacts

Deborah Da Costa, PhD

CONTACT

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

Data from ClinicalTrials.gov

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