Effectiveness of an Integrated Care Pathway for Depression: Cluster Randomized Controlled Trial

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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

Where this trial is running

• Centre for Addiction and Mental Health, Toronto, Ontario, Canada

Who to contact

Michelle U Ferreira, MEd · 4165358501 · michelle.ferreira@camh.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05142683.