Evidence-based Internet Cognitive-behavioral Therapy for Social Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- Change on the Social Phobia Inventory (SPIN)
研究概览
简要总结
The objectives of the study are to 1) to translate and adapt iCBT Shyness Program to the Canadian context; 2) to examine the completion and effectiveness of the Canadian adapted, including the French translated and English iCBT Shyness Program, in improving SAD symptoms; 3) to explore barriers and facilitating factors to the program's implementation. The overall study design is a hybrid effectiveness-implementation study of a quasi-experimental parallel group trial reflecting real world pathways (recommended and self-referrals). The project will be conducted in two Canadian provinces: Quebec (Montérégie) and Ontario. Prior to implementing the iCBT Shyness Program, it will undergo an initial adaptation to the Canadian context and focus groups will be conducted with key actor groups to discuss the adaptations to the graphics, narration of the modules, and this to better reflect varying sociocultural context among Canadian French- and English-speaking populations. We will then evaluate the outcomes associated with the implementation of the program in a three-pathway parallel trial. As a last step to this trial, semi-structured interviews will be conducted with study participants and health care providers to explore facilitating factors and barriers to the implementation of the iCBT adapted program.
详细描述
Study rational Social anxiety disorder (SAD) is one of the most prevalent anxiety disorders, with lifetime and past-year prevalence estimates reaching 12% and 7% in Canada. In the absence of treatment SAD is a chronic disorder with significant impairment in functioning associated with reduced school performance, loss of productivity, and decreased quality of life. During COVID-19, studies highlight increased mental health needs, but barriers to mental health service access due inpart to limited resources available. Viable therapy options for the treatment of SAD include CBT being delivered virtually, with effectiveness being shown in youth and adults. The Clinical Research Unit for Anxiety and Depression (CRUfAD) in Australia has developed, implemented, and demonstrated the effectiveness of an innovative guided and unguided internet delivered cognitive-behavioural therapy (iCBT) program for social anxiety. To make available high-quality and real-time evidence in response to the current COVID-19 mental health crisis and crucially needed access to psychological services to meet population mental health needs including for high risk populations (including individuals with pre-existing psychiatric conditions, youth and young adults, self identifying as belonging to a visible minority group (including from linguistic minority groups), we propose to conduct a Canadian adaptation of Australia's Shyness Program and to examine the adapted program's effectiveness, and implementation in two Canadian provinces (Quebec and Ontario).
Objectives
1) to translate and adapt iCBT Shyness Program to the Canadian context; 2) to examine the completion and effectiveness of the Canadian-adapted, including the French translated and English iCBT Shyness Program, in improving SAD symptoms; 3) to explore barriers and facilitating factors to the program's implementation.
Methods
The overall study design is a hybrid effectiveness-implementation study of a quasi-experimental parallel group trial reflecting real world pathways (recommended and self-referrals). The project will be conducted in two Canadian provinces: Quebec (Montérégie) and Ontario.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years; and
- •Speak and write in French or English; and
- •Have access to the internet and a digital device; and
- •Screen for social anxiety using the 17-item Social Phobia Inventory (SPIN) questionnaire (> 20).
排除标准
- •Self-report severe symptoms of depressions (PHQ-9 score ≥ 23); or
- •Thoughts they would be better off dead or hurting themselves on the 9th item of PHQ-9 in the past two weeks or thoughts or wishes to kill themselves on the 9th item of the Beck Depression Inventory-II; or
- •A diagnosis of schizophrenia, bipolar disorder or problems related to active substance use or dependence; or
- •Current use of benzodiazepines.
研究组 & 干预措施
Self-referred, undirected iCBT
These individuals will do the program, but will not receive follow-up contact during the program. In case of severe psychological distress (i.e. score ≥30 on Kessler's 10-item psychological distress scale (K10), participants will receive an automated email with a list of resources and emergency contact numbers.
干预措施: Self-referred, undirected Internet-based cognitive behavioral therapy for social anxiety (Behavioral)
Recommended, undirected iCBT
Participants will have received the recommendation from a healthcare professional (e.g., family physician, nurse or social worker, psychologist) to complete the adapted program without guidance. Clinicians will provide the name and email of the patients they are referring the program to without providing participants with in-program support but will consult the dashboard as they have clinical responsibility for the patient. In case of severe distress (i.e., K10 score ≥30), the referring healthcare professional will receive an automated email informing them to go to their dashboard to identify that patient. Participants will also receive an automated email with a list of resources and emergency contact numbers. To support the generalization of findings to the real-world (ecological validity), clinicians may follow-up with patients at their discretion.
干预措施: Recommended, undirected Internet-based cognitive behavioral therapy for social anxiety (Behavioral)
Recommended, directed iCBT
Participants will be recommended the intervention by a healthcare professional and be provided low-intensity guidance (e.g., email or brief phone contact [5 to 10 minutes] after Lesson 1 and 2, and then on an as-needed basis or patient request). Clinicians at the primary care sites participating in the study will be able to recommend the adapted program to their patients, will remain responsible for their patients and, will check their dashboard to see how their patients are progressing through the program. In the event of severe distress (i.e., K10 score ≥30) in a patient, the referring healthcare professional will receive an automated email informing them to go to their dashboard to identify that patient and assess the appropriate action to take. Participants will also receive an automated email with a list of resources and emergency contact numbers.
干预措施: Recommended, directed Internet-based cognitive behavioral therapy for social anxiety (Behavioral)
结局指标
主要结局
Change on the Social Phobia Inventory (SPIN)
时间窗: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)
Social Phobia Inventory (SPIN). The 17-item SPIN questionnaire will be used to assess social anxiety symptoms, which are rated on a 5-point scale from 0 (not at all) to 4 (extremely), with a possible score range from 0 to 68 (Connor et al., 2000). A cut-off \> 20 has been shown to reflect a probable case of SAD (Davidson, 2020).
次要结局
- Contacts with referring prescriber(6-month post-treatment)
- Change on the World Health Organization Disability Assessment Schedule (WHODAS 2.0)(Baseline to post-treatment (12-week and 6-month follow-up post-treatment))
- Change in Patient Health Questionnaire-8 (PHQ-8)(Baseline to post-treatment (12-week and 6-month follow-up post-treatment))
- Past 3 and 6-month health and social service use(Baseline and 6-month post-treatment)
- Self-reported satisfaction with iCBT program(12-week post-treatment)
- Change in Health-related quality of life (HRQOL)(Baseline to post-treatment (12-week and 6-month follow-up post-treatment))
- Change on the Kessler Psychological Distress Scale (K10)(Baseline to post-treatment (12-week and 6-month follow-up post-treatment))
- Change in generalized anxiety disorder scale (GAD-7)(Baseline to post-treatment (12-week and 6-month follow-up post-treatment))