CompletedNot Applicable

Cultural Adaptation of CBTi for the Arab World

Canada54 participantsStarted 2022-09-01

Plain-language summary

The goal of this clinical trial is to learn whether culturally adapted versions of Cognitive Behavioral Therapy for insomnia (CBTi) can reduce insomnia severity and improve sleep and mood outcomes in Arab adults with insomnia. The main questions it aims to answer are: Does culturally adapted CBTi (surface-level or surface + deep-level adaptations) reduce insomnia severity compared to a wait-list control condition? Are there differences in treatment efficacy between surface-level adaptations and combined surface + deep-level cultural adaptations of CBTi? Researchers will compare surface-level adapted CBTi, surface + deep-level adapted CBTi, and a wait-list control group to see if culturally adapted CBTi improves insomnia symptoms, sleep parameters, dysfunctional beliefs about sleep, anxiety, depression, and fatigue. Participants will: Be randomly assigned to one of three groups: surface-level adapted CBTi, surface + deep-level adapted CBTi, or a wait-list control Receive a culturally adapted CBTi intervention or remain on a wait-list during the study period Complete self-report questionnaires assessing insomnia severity, sleep beliefs, mood, and fatigue Complete sleep diaries at multiple time points across the study duration

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 + years * Arab descent (parents and grandparents born and raised in an Arab culture (Egypt, Morrocco, Algeria, Tunisia, Palestine, Libya, Sudan, Lebanon, Syria, Saudi Arabic, Yemen, UAE, Oman, Kuwait, Qatar, Bahrain)) * Arabic speaking * if migrated, after the age of 12 * meeting DSM-5 insomnia diagnosis, assessed by Insomnia Diagnostic Interview (Morin \& Espie, 2003) * ISI score \> 10 * no prior CBTi * stable medication or no psychiatric disorder as assessed by MINI Psychiatric Interview (Sheehan et al., 1998). Exclusion Criteria: * night-shift or atypical schedule (bedtime after 3am, wake up after 11 am, \>2 nights/week) * sleep altering medications * untreated comorbidity requiring imminent intervention as evaluated by MINI (Sheehan et al., 1998) * psychotic or bipolar disorder * other sleep disorder * cannabis use \> 2 days/week

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Insomnia severity index

Timeframe: pre-treatment, mid-treatment (6 weeks after time 1), post-treatment (approximately 9 weeks after time 1) and 3 months follow-up (approximately 3 months after post-treatment)

Trial details

NCT IDNCT07337369

SponsorLaval University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-20

View on ClinicalTrials.gov More Insomnia Disorder trials