Cultural Adaptation of CBTi for the Arab World

NCT07337369 | Completed DMC

• 1 other identifier: 2021-073
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Insomnia; Cultural Adaptation; Insomnia Disorder

Keywords

culturally tailored CBTi; insomnia; RCT; intercultural intervention; cultural adaptation

Outcome Measures

Primary Outcomes (1)

• Insomnia severity index

  The primary outcome was the Arabic validated version of the ISI. This scale shows strong internal consistency (Cronbach's alpha = .84) and convergent validity, correlating with the Pittsburgh Sleep Quality Index among Arabs (Suleiman \& Yates, 2011). The ISI is a 7-item self-reported measure of night-time and daytime insomnia symptoms (Bastien et al., 2001). Each item is rated on a five-point Likert scale (0-4). ISI scores range from 0-28, with higher scores indicating severe symptoms (Bastien et al., 2001; Morin et al., 2011). Since ISI score interpretation has not been yet validated for Arabs. ISI scores were interpreted based on Bastien et al. (2001) guidelines: non-clinical (0-7), subthreshold insomnia (8-14), clinical insomnia (moderate (15-21) and severe severity (22-28).

  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)

Secondary Outcomes (4)

• Hospital Anxiety and Depression scale

  baseline (time 1) and post-treatment (approximately 9 weeks after time 1)

• Multidimensional Fatigue Inventory

  baseline (time 1) and post-treatment (approximately 9 weeks after time 1)

• Dysfunctional Beliefs and Attitudes about sleep

  baseline (time 1), post-treatment (approximately 9 weeks after time 1) and at 3-month follow-up (approximately 3 months after post-treatment ((approximately 3 months after post-treatment))

• Sleep diary

  baseline (time 1), post-treatment (approximately 9 weeks after time 1) and at 3-month follow-up (approximately 3 months after post-treatment)

Study Arms (3)

Wait-list

NO INTERVENTION

received treatment (SD-CBTi) after an 8-week wait

Surface level adaptation to CBTi

EXPERIMENTAL

Therapy was delivered virtually to match participants' preferences and reduce barriers to access. The program was presented as sleep-focused to reduce mental health stigma and included additional psychoeducation about insomnia and available treatments. Engagement and retention were supported through frequent session reminders and access to the research team between sessions. These surface-level adaptations were identical for both intervention groups. In the surface-adapted CBTi group, the therapist used a directive approach, and 90-minute sessions equally emphasized cognitive and behavioral techniques.

Behavioral: Surface level adaptation

Surface+Deep level adaptation to CBTi

EXPERIMENTAL

Delivered in a group format emphasizing collectivist values to reduce loneliness related to insomnia and to involve family support through targeted psychoeducational materials. Session content reflected culturally specific experiences of insomnia, such as racing thoughts and spiritual coping strategies. The first two sessions focused primarily on cognitive techniques, followed by an equal emphasis on cognitive and behavioral strategies from session three onward. Sessions concluded with a brief spiritual mantra practice combining breathing and prayer, and the therapist adopted a less directive approach. Deep-level adaptations followed the Cultural Treatment Adaptation Framework and included a culturally grounded explanatory model of insomnia that emphasized culturally relevant causes, symptoms, coping strategies, and help-seeking behaviors. Cultural elements were integrated into sleep hygiene, behavioral, and cognitive techniques, including guidance on prayer, co-sleeping, gradual sle

Behavioral: Surface+deep level adaptations

Interventions

Surface+deep level adaptations BEHAVIORAL

2levels of deep adaptations. Core-modification. The explanatory model of insomnia for Arabs (El Gewely et al., 2024) replaced the standard "3P model" in session 1, highlighting cultural: causes, symptoms like "Thinking a lot", adaptative strategies (i.e. spiritual mantras) and help-seeking behaviors. Core-additions. Additional cultural elements were added to: sleep hygiene, cognitive and behavioral techniques. Sleep hygiene. Instructions targeted stimulating sleep environment, co-sleeping practices, prayers, herbal consumptions as well as biphasic sleep culture (e.g. allowing for 20-30 min nap from 3-6PM). Behavioral techniques. Sleep restriction was gradual: first two sessions participants were advised to follow regular sleep schedule; from session 3, sleep windows of at least six hours were allocated. Morning prayer practice was considered when needed. Additional hour was given on sleep windows during weekends to accommodate social commitments. Stimulus control included spiritu

Surface+Deep level adaptation to CBTi

Surface level adaptation BEHAVIORAL

Engagement. Therapy was offered virtually to accommodate participants' preference over internet-based compared to in-person treatment, based on our cohort and prior research (Ellis \& Miller-Graff, 2021). The intervention was framed as a sleep focused program to decrease mental health stigma. Additional psychoeducational increased awareness of insomnia treatment options. To enhance retention, frequent session reminders were sent, and participants were encouraged to contact the research team (MEG and NA) between sessions when needed. These surface-level adaptation were identical for S and SD-CBTi groups. Delivery. With S-CBTi group, the therapist was directive. Sessions lasted 90-minutes and incorporated cognitive and behavioral techniques equally.

Surface level adaptation to CBTi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Neuromed Clinic

Laval, Quebec, H7Y 1E2, Canada

Location

Related Publications (2)

• El Gewely, M., Leanza, Y., Moustafa, R. R., Attia, N., Hesham, H., Bastien, C., & Morin, C. M. (2024). Explanatory model of sleep and insomnia in the Arab world: A qualitative study. Sleep Medicine, 115, S176-S177. https://doi.org/10.1016/j.sleep.2023.11.500

  BACKGROUND

• Zhou ES, Ritterband LM, Bethea TN, Robles YP, Heeren TC, Rosenberg L. Effect of Culturally Tailored, Internet-Delivered Cognitive Behavioral Therapy for Insomnia in Black Women: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Jun 1;79(6):538-549. doi: 10.1001/jamapsychiatry.2022.0653.

  PMID: 35442432 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only participants are masked in this study. Participants are unaware of which version of the culturally adapted CBTi they receive or whether they are assigned to an active treatment or the wait-list condition. The therapist and research team are not masked due to the nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor at the School of Psychology

Model Details: Randomized controlled trial design. Participants are randomly assigned in equal proportions to one of three groups: surface-adapted CBTi, surface- and deep-adapted CBTi, or a wait-list control condition. Groups are followed concurrently, and outcomes are compared between groups across multiple assessment time points.

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: January 13, 2026
• Study Start: September 1, 2022
• Primary Completion: September 20, 2022
• Study Completion: December 23, 2023
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)