Clinical trial NCT06403995: Evidence-based Internet Cognitive-behavioral Therapy for Social Anxiety
Official title: Evidence-based Internet Cognitive-behavioral Therapy for Social Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Social Anxiety
Keywords: Anxiety
Social anxiety
Internet Cognitive behavioural therapy
Community-based primary health care
Quasi-experimental design
Canada
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2024-05-08
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individuals with social anxiety will either: 1) self-refer to the adapted intervention (self-referral, undirected iCBT); 2) be recommended the adapted intervention by a registered health professional and will complete the program without guidance (recommended, undirected iCBT); or 3) be recommended the adapted intervention by a registered health professional, with low-intensity guidance throughout the program (recommended, directed iCBT).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

To build on the current knowledge regarding the effectiveness of guided and unguided iCBT for SAD and inform on generalizability, we will evaluate the outcomes associated with the implementation of the program in a three-pathway parallel trial. The iCBT Shyness Program includes six online lessons based on CBT strategies with homework assignments to be completed within 90 days. The study will be carried out in Quebec and Ontario.

Phase 1:

Prior to implementing the iCBT Shyness Program, it will undergo an initial adaptation to the Canadian context. Focus groups in each province will be conducted with key actor groups (patients-partners, community leaders, service providers, i.e., consultant-partners to the research team) to discuss the adaptations to the graphics, narration of the modules, and this to better reflect varying sociocultural context (e.g., socioeconomically disadvantaged environment; cultural backgrounds) among Canadian French- and English-speaking populations.

Phase 2:

Then, individuals with social anxiety will either: 1) self-refer to the adapted intervention (self referral, undirected iCBT); 2) be recommended the adapted intervention by a registered health professional and will complete the program without guidance (recommended, undirected iCBT); or 3) be recommended the adapted intervention by a registered health professional, with low intensity guidance throughout the program (recommended, directed iCBT). The program will be implemented via the virtual clinic at Université de Sherbrooke (www.equilia.ca), as we have acquired and implemented a license for the virtual clinic in Canada. Data collection will be integrated into the virtual clinic web platform and the REDCap platform and carried out at baseline, at the beginning of each lesson, 12-week and 6-month follow-up. Individual-level outcomes measured will include anxiety and depressive symptoms, psychological distress, disability, health-related quality of life as well as health service utilization and satisfaction.

Phase 3:

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, and this to inform implementation strategies for wider use across Canada.

Anticipated results

This study will provide evidence on the effectiveness, barriers and facilitating factors to implementing a low-intensity iCBT in the Canadian context for SAD, which will bridge an important care gap for undeserved populations in Canada with SAD. Findings will inform the eventual scaling up of the program in community-based primary health care across Canada. This would improve equity of the health care system by helping a large number of Canadians including those from visible, socio-cultural, and linguistic minority groups timely access to mental health services post-pandemic.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change on the Social Phobia Inventory (SPIN)
timeFrame: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)
Secondary outcomes:
measure: Change on the World Health Organization Disability Assessment Schedule (WHODAS 2.0)
timeFrame: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)
measure: Change in Health-related quality of life (HRQOL)
timeFrame: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)
measure: Change on the Kessler Psychological Distress Scale (K10)
timeFrame: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)
measure: Change in Patient Health Questionnaire-8 (PHQ-8)
timeFrame: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)
measure: Change in generalized anxiety disorder scale (GAD-7)
timeFrame: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)
measure: Past 3 and 6-month health and social service use
timeFrame: Baseline and 6-month post-treatment
measure: Self-reported satisfaction with iCBT program
timeFrame: 12-week post-treatment
measure: Contacts with referring prescriber
timeFrame: 6-month post-treatment
Other outcomes:
measure: Change in loneliness and social isolation
timeFrame: Baseline to post-treatment (12-week and 6-month follow-up post-treatment)
Locations:
city: Greenfield Park
country: Canada
facility: CISSS de la Montérégie-Centre
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie - CHUS
state: Quebec
Study officials:
References: