Cultural Adaptation of CBTi for the Arab World

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 Disorder
• Insomnia
• Cultural Adaptation

Interventions

BEHAVIORAL

Surface+deep level adaptations

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

BEHAVIORAL

Surface level adaptation

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.

Sponsors & Collaborators

• Laval University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-01

Primary Completion

2022-09-20

Completion

2023-12-23

Countries

• Canada

Study Locations