Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT05134103
Brief Summary:
Utilization of therapist Assisted internet-delivered cognitive behavioural therapy (TAiCBT) for treating depression and anxiety disorders in stepped-care models, such as the UK's Improving Access to Psychological Therapies (IAPT) and the Ontario Structured Psychotherapy Program (SPP), is a potential solution for addressing the treatment gap in mental health. Investigators propose to investigate the effectiveness of Beacon TAiCBT for Depression to demonstrate the potential value of TAiCBT in a stepped care model. Investigators propose to conduct a 12-week pragmatic randomized controlled trial with a 1:1 (iCBT intervention: waiting-list) allocation, for participants referred to the Anxiety and Mood, Prompt Anxiety and Mood, and Trauma Programs at Ontario Shores Centre for Mental Health Sciences and on a waiting-list to receive clinical service.
The primary outcome measures will be the Improving Access to Psychological Therapies (IAPT) definitions of Recovery, Reliable Improvement, and Reliable Recovery which are derived using the PHQ-9 and GAD-7 . The PHQ-9 (Depression), GAD-7 (anxiety) and WSAS (functional impairment) will be used as secondary outcome measures for all participants.
Over the course of the study, 200 participants will be randomized (iCBT, 100; waiting-list, 100). Statistical analyses will include intention-to-treat analyses to test the interaction effects for the primary outcome measures at discharge/12-weeks and 3, and 12 months post-treatment.
It is predicted that participants in the treatment condition will show significantly reduced symptoms of depression related to the waitlist control. It is predicted that this will be maintained through follow up.
Study:
NCT05134103
Study Brief:
Protocol Section:
NCT05134103