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CARIBOU-2 for Depression (CARIBOU-2 Trial)

N/A

Recruiting

Led By Darren B Courtney, MD

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 24 weeks

Awards & highlights

CARIBOU-2 Trial Summary

This trial is testing two different approaches for treating teenagers with depressive symptoms. One approach is the usual treatment, while the other is a more integrated care pathway. The main goal is to see if the integrated

Who is the study for?

This trial is for teens aged 13-18 who are experiencing depression as a main issue, confirmed by a questionnaire and clinician agreement. They should be new to the treatment site or not have received treatment in the past 3 months.Check my eligibility

What is being tested?

The study compares usual depression treatments with an Integrated Care Pathway (ICP) approach. It's designed to see if ICP is more effective in community settings at reducing depressive symptoms and improving function and caregiver perception of symptoms.See study design

What are the potential side effects?

Since this trial involves standard care and counseling methods rather than medication, side effects may include emotional discomfort or distress during therapy sessions but are generally considered low risk.

CARIBOU-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Childhood Depression Rating Scale-Revised

Secondary outcome measures

Adolescent Alcohol and Drug Involvement Scale Grid

Cognitive Behavioural Therapy Skills Questionnaire

CollaboRATE

+6 more

CARIBOU-2 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CARIBOU-2Experimental Treatment1 Intervention

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.

Group II: Treatment as UsualActive Control1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenOTHER

691 Previous Clinical Trials

6,945,314 Total Patients Enrolled

3 Trials studying Depression

1,695 Patients Enrolled for Depression

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,214 Total Patients Enrolled

44 Trials studying Depression

3,273,023 Patients Enrolled for Depression

Centre for Addiction and Mental HealthLead Sponsor

356 Previous Clinical Trials

81,158 Total Patients Enrolled

85 Trials studying Depression

18,951 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the study open to individuals who are 80 years of age or older?

"Individuals aged between 13 and 18 years are eligible to participate in this research endeavor. Notably, there is a total of 233 trials catering to the needs of participants under the age of majority while an additional 1058 studies target those above the age of retirement."

Answered by AI

Which individuals are eligible to take part in this research investigation?

"To qualify for this research project, individuals must be adolescents aged between 13 and 18 years old and have a diagnosis of depression. Approximately 300 participants will be enrolled in the study."

Answered by AI

Are there any available openings for patients to participate in this medical study?

"As per clinicaltrials.gov, this research study is currently in the process of patient recruitment. The trial was initially uploaded on February 1st, 2022, and underwent its latest update on March 20th, 2024."

Answered by AI

How many participants are enrolled in the entirety of this research investigation?

"Indeed, the information available on clinicaltrials.gov confirms that patient recruitment is ongoing for this trial. The trial was originally posted on February 1st, 2022, and last updated on March 20th, 2024. It aims to enroll 300 patients across a single location."

Answered by AI

Recent research and studies

Medical CareJournal

Effectiveness-implementation Hybrid Designs

Curran, Geoffrey M., Mark Bauer, Brian Mittman, Jeffrey M. Pyne, and Cheryl Stetler. 2012. “Effectiveness-implementation Hybrid Designs”. Medical Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mlr.0b013e3182408812.

clinicaltrials.govStudy

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

2022. "Effectiveness of an Integrated Care Pathway for Depression: Cluster Randomized Controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05142683.