Randomized Controlled Trial on Precision Mental Health

Обзор

The current study aims to evaluate the effectiveness of different online psychological interventions, including guided and unguided transdiagnostic cognitive behavioural therapy, and unguided mindfulness-based intervention, on mental well-being in comparison to waitlist control. It is hypothesized that participants with the guided psychological intervention will show (H1) a greater reduction in mental health symptoms, and (H2) better mental well-being compared with participants with unguided psychological intervention and the control condition.

Подробное описание

In Hong Kong, insufficient resources in the current public health system lead to a long waiting time. Mental health services provided by the public health system mainly rely on traditional one-to-one face-to-face sessions. In the past 12 months, there were 47,879 new bookings in public psychiatry outpatient clinics and the longest waiting time was 94 weeks. Priority is always given to people with more severe mental health issues, which causes long waiting time for people with mild mental health symptoms. Untreated mental health issues can be escalated to more severe symptoms. Thus, in addition to treating mental illness, preventing common mental health issues and fostering mental health self-care in the general population are crucial to promote public mental health and reduce the illness burden in society.

Rather than resorting to mental health professionals for face-to-face service to treat common mental health concerns, digital technology provides a highly scalable and accessible means through which individuals can access mental health resources for self-care. Internet-delivered psychological therapy is one of the viable options for this situation. Internet-delivered cognitive behavioural therapy (ICBT) has been recommended by the NICE guidelines as one of the low-intensity interventions for people with depression and anxiety. Online scientific evidence-based psychological interventions provide solutions for the service users on their mental well-being issues without practical burdens resulted from long waiting time, high expenses, and stigmatization.

Internet-delivered mindfulness-based intervention (MBI) have emerged as a promising approach in reducing depressive and anxiety symptoms and improving mental well-being. A meta-analysis found that online MBIs had beneficial impact on depression, anxiety, well-being and mindfulness. It also found that guided online MBIs had larger effects on stress and mindfulness compared to unguided MBIs.

In this study, participants will be recruited through (1) advertising on online networking platforms (e.g., Facebook and Instagram), (2) mass mailing at investigator's institutions, and (3) snowball sampling.

Upon completing the screening and pre-evaluation questionnaire, participants will be randomly assigned to one of the groups based on computer-generated random digits. They will complete 5 more sets of questionnaires, including a mid-evaluation 4 weeks after group allocation, a post-evaluation 8 weeks after group allocation, and three follow-up questionnaires at 16 weeks, 6 months, and 12 months after group allocation. In experimental groups, participants will complete guided or self-guided transdiagnostic cognitive behavioural therapy, or self-guided mindfulness-based intervention within 8 weeks. In the waitlist control group, participants are to refrain from participating in psychological intervention until they finish the follow-up questionnaire.

Вмешательства

• Поведенческое Online guided transdiagnostic cognitive behavioural therapy
  The contents of guided transdiagnostic cognitive behavioural therapy are developed by clinical psychologists and psychological well-being officers. The intervention consists of 8 modules. Contents include emotional awareness, physical sensation, emotion-driven behavior, behavioral activation, worry, cognitive restructuring, behavioral experiment, and relapse prevention. Customized guidance will be provided by coaches once a week based on participants' performance
• Поведенческое Online self-guided transdiagnostic cognitive behavioural therapy
  The contents of self-guided transdiagnostic cognitive behavioural therapy are developed by clinical psychologists and psychological well-being officers. The intervention consists of 8 modules. Contents include emotional awareness, physical sensation, emotion-driven behavior, behavioral activation, worry, cognitive restructuring, behavioral experiment, and relapse prevention. No customized guidance will be provided to participants in the self-guided group.
• Поведенческое Online self-guided mindfulness-based intervention
  The contents of online self-guided mindfulness-based intervention are developed by clinical psychologists and psychological well-being officers. The intervention consists of 6 modules. Contents include mindfulness and auto-pilot, react and respond, aversion, craving, equanimity, and 'suffering', thoughts and letting go, starting with loving kindness, and mindfulness in life.

Первичные конечные точки

• Patient Health Questionnaire [Срок оценки: 8th week]
• Patient Health Questionnaire [Срок оценки: 16th week]
• Generalized Anxiety Disorder Assessment [Срок оценки: 8th week]
• Generalized Anxiety Disorder Assessment [Срок оценки: 16th week]
• The Short Warwick-Edinburgh Mental Wellbeing Scale [Срок оценки: 8th week]
• The Short Warwick-Edinburgh Mental Wellbeing Scale [Срок оценки: 16th week]

Вторичные конечные точки (12)

• The Brief Experiential Avoidance Questionnaire (BEAQ) [Срок оценки: 8th week]
• The Brief Experiential Avoidance Questionnaire (BEAQ) [Срок оценки: 16th week]
• Behavioral Activation for Depression Scale - Short Form [Срок оценки: 8th week]
• Behavioral Activation for Depression Scale - Short Form [Срок оценки: 16th week]
• Intolerance of Uncertainty Scale (Short version) [Срок оценки: 8th week]
• Intolerance of Uncertainty Scale (Short version) [Срок оценки: 16th week]
• Emotion Regulation Questionnaire (ERQ) [Срок оценки: 8th week]
• Emotion Regulation Questionnaire (ERQ) [Срок оценки: 16th week]
• Anxiety Sensitivity Index-3 [Срок оценки: 8th week]
• Anxiety Sensitivity Index-3 [Срок оценки: 16th week]
• Ruminative response scale-short version [Срок оценки: 8th week]
• Ruminative response scale-short version [Срок оценки: 16th week]

Критерии участия

Критерии включения

• 17 years old or above
• Able to read Chinese or English
• With internet connection and able to access the internet
• Does not register to Jockey Club TourHeart+ Project or participate in related research projects
• With moderate-severe GAD-7 a/o moderate-severe PHQ-9

Критерии исключения

• People who are under 17 years old
• Cannot access the internet
• Existing users of Jockey Club TourHeart+ Project or participate in related research
• Without moderate-severe depressive or anxiety symptoms
• With suicidal risk

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• Diversity and Well-being Lab, Dept of Psychology, CUHK — Shatin

Публикации

• Abd-Alrazaq AA, Alajlani M, Alalwan AA, Bewick BM, Gardner P, Househ M. An overview of the features of chatbots in mental health: A scoping review. Int J Med Inform. 2019 Dec;132:103978. doi: 10.1016/j.ijmedinf.2019.103978. Epub 2019 Sep 25. PMID 31622850
• Carleton RN, Norton MA, Asmundson GJ. Fearing the unknown: a short version of the Intolerance of Uncertainty Scale. J Anxiety Disord. 2007;21(1):105-17. doi: 10.1016/j.janxdis.2006.03.014. Epub 2006 May 2. PMID 16647833
• Chio, F. H., Lai, M. H., & Mak, W. W. (2018). Development of the Nonattachment Scale-Short Form (NAS-SF) using item response theory. Mindfulness, 9, 1299-1308.
• Choi I, Andrews G, Sharpe L, Hunt C. Help-seeking characteristics of Chinese- and English-speaking Australians accessing Internet-delivered cognitive behavioural therapy for depression. Soc Psychiatry Psychiatr Epidemiol. 2015 Jan;50(1):89-97. doi: 10.1007/s00127-014-0956-3. Epub 2014 Sep 6. PMID 25193374
• Dorow M, Lobner M, Pabst A, Stein J, Riedel-Heller SG. Preferences for Depression Treatment Including Internet-Based Interventions: Results From a Large Sample of Primary Care Patients. Front Psychiatry. 2018 May 17;9:181. doi: 10.3389/fpsyt.2018.00181. eCollection 2018. PMID 29867605
• Gamez W, Chmielewski M, Kotov R, Ruggero C, Suzuki N, Watson D. The brief experiential avoidance questionnaire: development and initial validation. Psychol Assess. 2014 Mar;26(1):35-45. doi: 10.1037/a0034473. Epub 2013 Sep 23. PMID 24059474
• Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348. PMID 12916575
• He J, Liu Y, Cheng C, Fang S, Wang X, Yao S. Psychometric Properties of the Chinese Version of the 10-Item Ruminative Response Scale Among Undergraduates and Depressive Patients. Front Psychiatry. 2021 May 26;12:626859. doi: 10.3389/fpsyt.2021.626859. eCollection 2021. PMID 34122165

Идентификаторы

NCT: NCT05825040 · WMHICS-HK

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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