NCT05134103

Mindbeacon Therapist Assisted Internet Delivered CBT for Depression

A 12-week Randomized Waitlist-Controlled Trial of Mindbeacon Therapist Assisted Internet Delivered CBT for Depression

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ontario Shores Centre for Mental Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Mindbeacon Therapist Guided, Internet Cognitive Behavioral Therapy for Depression	The treatment consists of 11 depression modules delivered approximately once per week (at therapists' discretion) over a period of 12 weeks. Additionally, the therapist typically tailors treatment to client's individual needs by including supplementary modules for a variety of issues such as generalized anxiety, panic, social anxiety, post-traumatic stress, insomnia, pain, and relationships etc. Clients can complete the readings, exercises, and worksheets at any convenient time, using their web-enabled smartphone, tablet, or computer. Access to the modules and all messaging is provided through the secure platform. Messaging is "asynchronous" meaning participants can message their therapist as often as they choose and expect a response within 1-2 business days. After 12 weeks of active treatment, they will have unguided access (without therapist support) to the treatment materials that were covered for an additional 40 weeks.
OTHER	Waitlist Control Group	Participants assigned to this arm will wait for 12 weeks before receiving active treatment condition

Timeline

• Start date: 2021-11-01
• Primary completion: 2021-11-18
• Completion: 2021-11-18
• First posted: 2021-11-24
• Last updated: 2023-04-18