NCT05142683 Effectiveness of an Integrated Care Pathway for Depression: Cluster Randomized Controlled Trial
| NCT ID | NCT05142683 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre for Addiction and Mental Health |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2022-02-01 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This a stepped wedged cluster RCT with two intervention arms--Treatment As Usual (TAU) and an Integrated Care Pathway (ICP). Eligible participants are between the ages of 13 and 18, who present to community mental health agencies with depressive symptoms as the primary concern. The primary objective is to establish the clinical effectiveness of the ICP intervention in the community setting relative to TAU, with respect to reducing evaluator-rated depressive symptoms. The secondary objectives are to explore changes in clinician-rated function and caregiver-rated symptoms for youth receiving the ICP intervention relative to TAU. The third objective is to explore the implementation effectiveness of the ICP intervention, namely investigating: feasibility, fidelity, cost and acceptability. Edited on March 7th, 2024: This is a quasi-experimental, multi-site cluster controlled clinical trial design with two intervention arms--Treatment As Usual (TAU) and an Integrated Care Pathway (ICP). Eligible participants are between the ages of 13 and 18, who present to community mental health agencies with depressive symptoms as the primary concern. The primary objective is to establish the clinical effectiveness of the ICP intervention in the community setting relative to TAU, with respect to reducing evaluator-rated depressive symptoms. The secondary objectives are to explore changes in clinician-rated function and caregiver-rated symptoms for youth receiving the ICP intervention relative to TAU. The third objective is to explore the implementation effectiveness of the ICP intervention in the community setting, namely investigating: feasibility, fidelity, cost and acceptability.
Eligibility Criteria
Inclusion Criteria: * Youth is aged 13 to 18 years, inclusive. * Youth and/or their caregiver is expressing that 'depression" (or some synonym) is a concern. * Clinician agrees that depressive symptoms are a treatment target. * Mood and Feelings Questionnaire score is ≥22 at two sequential visits (screening and baseline assessment). * Youth must be new to the site (in past 3 months) or have a period of no treatment for 3 months Exclusion Criteria: * Known or highly suspected presentations of psychotic symptoms that are persistent, affect functioning, and have observable effects on behaviour. * Severe substance use disorder, bipolar disorder, autism spectrum disorder or intellectual disability, severe eating disorder, imminent risk of suicide requiring hospitalization as per judgment of the assessing clinician. * Inability to provide informed consent to the study for any reason * Youth currently in Day Treatment
Contact & Investigator
Darren B Courtney, MD
PRINCIPAL INVESTIGATOR
University of Toronto
Frequently Asked Questions
Who can join the NCT05142683 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 18 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05142683 currently recruiting?
Yes, NCT05142683 is actively recruiting participants. Contact the research team at michelle.ferreira@camh.ca for enrollment information.
Where is the NCT05142683 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05142683 clinical trial?
NCT05142683 is sponsored by Centre for Addiction and Mental Health. The principal investigator is Darren B Courtney, MD at University of Toronto. The trial plans to enroll 300 participants.