Mental Health Issue Clinical Trial
Official title:
Developing, Administering, and Evaluating Online Psychotherapy and Psychoeducation Programs for Postsecondary Students Within a Regional Mental Health Hub in Ontario, Canada Using AI-assisted Online Interventions
NCT number | NCT05754723 |
Other study ID # | 6034514 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | May 5, 2022 |
Est. completion date | April 6, 2023 |
Verified date | April 2024 |
Source | Queen's University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The prevalence of mental health challenges and disorders in post-secondary students, demands accessible and efficacious care. Online psychotherapy and psychoeducation programs have shown significant effectiveness in mitigating the risk and clinical symptoms of various mental health disorders. Additionally, artificial intelligence (AI) has become an accessible, effective, and scalable tool supporting the delivery of healthcare. Therefore, the primary objective of this study is to develop an AI-driven online mental health care hub in the Kingston, Frontenac, Lennox & Addington region for post-secondary students. . This hub will deliver equitable, efficacious, and cost-effective online psychoeducation and psychotherapy in the form of online diagnosis-specific cognitive behavioural therapy (e-CBT). The hub's virtual design aims to adequately address existing gaps in the mental healthcare of these individuals and alleviate the burden placed on mental health services in Canada. Using a rigorous implementation framework, the development of this hub is designed as a multiphase study with three phases. (1) Pre-adoption phase: will assess post-secondary students' current mental health landscape through surveys and focus groups. This information will be used in the development of our online psychoeducation and diagnosis-specific e-CBT programs. (2) Delivery phase: will determine the efficacy and cost-effectiveness of the online psychoeducation and diagnosis-specific e-CBT programs by comparing them to treatment as usual. (3) Post-adoption phase: the collected data from these programs will be analyzed and shared with key stakeholders to guide continuous program scaling and improvement.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 6, 2023 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - post-secondary students enrolled in institutions of interest - the ability to provide informed consent - the ability to speak and read English - consistent and reliable access to the internet Exclusion Criteria: - N/A |
Country | Name | City | State |
---|---|---|---|
Canada | Queen's University, Hotel Dieu Hospital | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Dr. Nazanin Alavi |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in anxiety severity (GAD-7) | Generalized anxiety disorder - 7 item (GAD-7) questionnaire. Increase in score dictates increase in severity. Scale of 0-3 | weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months | |
Primary | Change in depression severity (PHQ-9) | Patient Health Questionnaire - 9 item (PHQ-9). Increase in score dictates increase in severity. Scale of 0-3 on each question. | weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months | |
Primary | Change in depression severity (QIDS) | Quick Inventory of Depressive Symptomatology (QIDS). Increase in score dictates increase in severity. Scale of 0-3 on each question | weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months | |
Primary | Change in stress severity (DASS-42) | Depression Anxiety Stress Scale-42 (DASS-42). Increase in score dictates increase in severity. Scale of 0-3 on each question. | weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months | |
Primary | Change in quality of life (AQoL-8D) | Assessment of Quality of Life-8D (AQoL-8D). Increase in score dictates increase in quality of life (improvement). Scale of 0-5 on each question. | weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months | |
Primary | Change in resilience (RS-14) | Resilience Scale-14 (RS-14). Increase in score dictates increase in resilience (improvement). Scale of 0-7 on each question | weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months | |
Primary | Change in social anxiety severity (LSAS) | Liebowitz Social Anxiety Scale (LSAS). Increase in score dictates increase in anxiety severity. Scale of 0-3 on each question. | weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months | |
Primary | Change in ADHD severity (ASRS) | Adult ADHD Self-Report Scale (ASRS). Increase in score dictates increase in ADHD symptom severity. Scale of 0-5 on each question. | weeks 0, 3, 6, follow-up 1, 2, 3, 4, 5, 6 months |
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