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NCT05134103
Mindbeacon Therapist Assisted Internet Delivered CBT for Depression
NA trial testing Mindbeacon Therapist Guided, Internet Cognitive Behavioral Therapy for Depression in Major Depressive Disorder. Withdrawn.
18 November 2021
Quick facts
| Lead sponsor | Ontario Shores Centre for Mental Health Sciences |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 November 2021 |
| Primary completion | 18 November 2021 |
| Estimated completion | 18 November 2021 |
Drugs / interventions tested
- Mindbeacon Therapist Guided, Internet Cognitive Behavioral Therapy for Depression
- Waitlist Control Group
Conditions studied
- Major Depressive Disorder — all drugs for Major Depressive Disorder →
Sponsor
Ontario Shores Centre for Mental Health Sciences
Who can join
18 and older, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05134103
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Currently open trials in the same condition.
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Other Ontario Shores Centre for Mental Health Sciences trials
Trials by the same sponsor.
- NCT06323486 — Accelerated Bilateral Sequential Theta Burst Stimulation in Older Adults With Treatment-resistant Depression · NA · unknown
- NCT04935489 — Accelerated Intermittent Theta Burst Stimulation for Depressed Patients During the Covid-19 Pandemic · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05134103 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ontario Shores Centre for Mental Health Sciences
- Last refreshed: 18 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05134103.
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