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

NCT05142683 | Recruiting DMC

• 1 other identifier: 019/2021
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Adolescents; Integrated Care Pathway; Depression; Measurement Based Care; Implementation

Outcome Measures

Primary Outcomes (1)

• Childhood Depression Rating Scale-Revised

  A 17-item measure rated by an RA following a semi-structured interview with the adolescent relating to symptoms of depression over the past 2 weeks. The RA will be blind to treatment assignment.

  Change from baseline to 24 weeks

Secondary Outcomes (9)

• Columbia Suicide Severity Rating Scale

  Change from baseline to 24 weeks

• Depression Rating Scale

  Change from baseline to 24 weeks

• Youth Quality of Life Scale Research Version

  Change from baseline to 24 weeks

• Health and Social Service Utilization

  Change from baseline to 24 weeks

• Ontario Perception of Care Tool for Mental Health and Addictions

  Change from baseline to 24 weeks

Study Arms (2)

Treatment as Usual

ACTIVE COMPARATOR

Study involvement for all sites will begin in the TAU condition, which is the typical treatment at the participating community mental health agency. A range of treatments observed in our previous survey of sites will be on offer in these agencies, depending on the preferences and context of the local agency. In typical TAU in community mental health agencies, depressive symptoms and function are not systematically monitored via standardized rating scales. TAU may or may not include referral to psychotherapy and/or parent support. There are no prompts to prescribe specific medications, and/or internal and external referrals to treatment and other services, guided by local service standards.

Other: Treatment As Usual

CARIBOU-2

EXPERIMENTAL

After the CARIBOU-1 pilot study, the Principal Investigator revised the ICP to render it more applicable to community settings as well as offer a second-line psychotherapy ("Brief Psychosocial Intervention") for youth who do not engage with, or respond to, cognitive-behavioural therapy. The revised version is called the CARIBOU-2 intervention. The current iteration of the pathway involves a series of steps: (1) structured assessment, including safety assessment; (2) education on depression, sleep, exercise, and diet; (3) psychotherapy (with 1st line Cognitive Behavioural Therapy, 2nd line "Brief Psychosocial Intervention"); (4) a caregiver structured support group; (5) medication options (1st line fluoxetine, 2nd line sertraline); (6) "team reviews" every four weeks, (meeting with the youth and involved clinicians to review measures and discuss treatment changes); and, (7) discharge and follow-up planning.

Other: CARIBOU-2

Interventions

Treatment As Usual OTHER

Various typical interventions for adolescents with depression.

Treatment as Usual

CARIBOU-2 OTHER

Integrated Care Pathway intervention for adolescents with depression.

CARIBOU-2

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify 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 qualify 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• The Hospital for Sick Children: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

RECRUITING

Related Publications (6)

• Bennett K, Courtney D, Duda S, Henderson J, Szatmari P. An appraisal of the trustworthiness of practice guidelines for depression and anxiety in children and youth. Depress Anxiety. 2018 Jun;35(6):530-540. doi: 10.1002/da.22752. Epub 2018 Apr 26.

  PMID: 29697887 BACKGROUND

• Courtney D, Bennett K, Henderson J, Darnay K, Battaglia M, Strauss J, Watson P, Szatmari P. A Way through the woods: Development of an integrated care pathway for adolescents with depression. Early Interv Psychiatry. 2020 Aug;14(4):486-494. doi: 10.1111/eip.12918. Epub 2019 Dec 27.

  PMID: 31883210 BACKGROUND

• Courtney DB, Bennett K, Szatmari P. The Forest and the Trees: Evidence-Based Medicine in the Age of Information. J Am Acad Child Adolesc Psychiatry. 2019 Jan;58(1):8-15. doi: 10.1016/j.jaac.2018.06.035.

  PMID: 30577942 BACKGROUND

• Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.

  PMID: 22310560 BACKGROUND

• Hytman L, Mansueto S, Chan JI, Kumar R, Nguyen ATP, Wang W, Krause KR, Monga S, Szatmari P, Courtney DB. Interrater Reliability and Measurement Error of the Children's Depression Rating Scale-Revised in Adolescents. JAACAP Open. 2025 Jun 20;3(4):1225-1235. doi: 10.1016/j.jaacop.2025.06.005. eCollection 2025 Dec.

  PMID: 41367969 DERIVED

• de Oliveira C, Mason J, Amani B, Liddell G, Szatmari P, Henderson J, Courtney D. Protocol for the economic evaluation of the Care for Adolescents who Received Information 'Bout Outcomes, 2nd iteration (CARIBOU-2) non-randomised, cluster-controlled trial of an integrated care pathway for depression in adolescents. BMJ Open. 2025 May 15;15(5):e092541. doi: 10.1136/bmjopen-2024-092541.

  PMID: 40379352 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Darren B Courtney, MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle U Ferreira, MEd

CONTACT

4165358501; michelle.ferreira@camh.ca

Bahar Amani, PhD

CONTACT

4165358501; bahar.amani@camh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluator of the primary outcome will be blind to treatment arm as well as blind to the stepped wedge design. Edited March 7th, 2024: The evaluator of the primary outcome will be blind to treatment arm as well as blind to the quasi-experimental cluster controlled design.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study uses a Type 1 Hybrid Implementation Effectiveness design that focuses on the effectiveness of the clinical intervention (ICP) while exploring the implementation effectiveness of the intervention. A stepped wedge, cluster randomized controlled trial is indicated as the intervention is applied at the clinic level. Edited on March 7th, 2024: The study uses a Type 1 Hybrid Implementation Effectiveness design that focuses on the effectiveness of the clinical intervention (ICP) while exploring the implementation effectiveness of the intervention. A cluster controlled trial is indicated as the intervention is applied at the clinic-level.

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 2, 2021
• Study Start: February 1, 2022
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)