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临床试验/NCT07337369
NCT07337369已完成不适用

Cultural Adaptation of Cognitive Behavioral Therapy for Insomnia for the Arab World

Laval University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2022年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
Insomnia severity index

研究概览

简要总结

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

详细描述

Insomnia is a common sleep problem that affects how people fall asleep, stay asleep, and feel during the day. One of the most effective non-medication treatments for insomnia is Cognitive Behavioral Therapy for Insomnia (CBTi). CBTi helps people change unhelpful thoughts and behaviors related to sleep. However, most CBTi programs have been developed and tested in Western countries, and much less is known about how well they work for people from other cultural backgrounds.

Research has shown that individuals from southern cultures, including Arab populations, are often underrepresented in mental health research. This gap is important because culture influences how people understand health problems, seek help, and engage with treatment. Two key findings motivated the current study. First, earlier research found that Syrians showed lower engagement in CBTi, suggesting that standard CBTi may not fully meet the needs of Arab clients. Second, our own qualitative research showed that Arabs often understand sleep and insomnia in culturally specific ways. For example, insomnia is commonly described as a mental or cognitive issue-often referred to as "overthinking"-rather than as a purely biological sleep disorder. Many people also hold social or spiritual explanations for insomnia, such as the belief that sleep problems may be caused by the evil eye or reflect a lack of faith. These beliefs can influence whether and how individuals seek help, with many turning to spiritual practices rather than psychological treatments.

Together, these findings suggest that tailoring CBTi to Arab cultural beliefs and practices may improve its relevance and effectiveness. To guide this process, the study used the Cultural Treatment Adaptation Framework (CTAF), a research-based model that distinguishes between surface-level adaptations, which focus on how treatment is delivered (for example, language, format, and engagement strategies), and deep-level adaptations, which modify core elements of treatment to reflect cultural values, beliefs, and explanatory models of illness.

This pilot randomized controlled trial aimed to compare:

  1. A surface-adapted version of CBTi (S-CBTi)
  2. A combined surface- and deep-adapted version of CBTi (SD-CBTi)
  3. A wait-list control condition (WL)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Surface level adaptation (Behavioral)

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

干预措施: Surface+deep level adaptations (Behavioral)

结局指标

主要结局

Insomnia severity index

时间窗: 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)

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).

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charles M. Morin

professor at the School of Psychology

Laval University

研究点 (1)

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