Integrated Care Pathway for Depression

(CARIBOU-2 Trial)

Overseen By Bahar Amani, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Disqualifiers: Psychotic symptoms, Substance use, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treating depression in teens, called the Integrated Care Pathway (ICP), against regular treatment methods. The ICP includes steps such as therapy, education on lifestyle factors, medication, and support for caregivers. The trial aims to determine if this new approach can more effectively reduce depressive symptoms compared to standard care. Teens aged 13 to 18 with depression as a primary concern who have recently started treatment at a participating center might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options that could enhance the care experience.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Integrated Care Pathway (ICP) for treating depression in teenagers is generally safe. Previous studies have found that components of the ICP, such as talk therapy (Cognitive Behavioral Therapy or CBT) and medications like fluoxetine and sertraline, are usually well-tolerated by most teens. These treatments are commonly used and have proven safety records.

The ICP also includes regular check-ups to ensure safety, education on healthy habits, and support for family members. Earlier research with similar programs reported no major side effects, suggesting that the ICP is a safe choice for managing depression in young people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Integrated Care Pathway (ICP) for depression because it offers a structured and comprehensive approach that combines education, psychotherapy, caregiver support, and medication, all tailored to community settings. Unlike traditional treatments that may not systematically monitor symptoms or provide a clear treatment roadmap, the ICP includes regular team reviews to adjust treatments as needed, ensuring personalized care. Additionally, it offers a second-line Brief Psychosocial Intervention for youth who don't respond to cognitive-behavioral therapy, providing more options for effective treatment. This holistic and adaptable approach aims to improve outcomes compared to usual care, where such structured support and monitoring are often lacking.

What evidence suggests that this trial's treatments could be effective for depression?

Research has shown that the Integrated Care Pathway (ICP), one of the treatments studied in this trial, can improve outcomes for teenagers with depression. Early results suggest this method leads to better symptom relief and daily functioning compared to Treatment As Usual (TAU), the other treatment arm in this trial. The ICP includes organized check-ups, education about depression, and personalized therapies such as Cognitive Behavioral Therapy, which helps change thinking patterns. It also offers structured support for caregivers and includes medication options if necessary. This comprehensive approach shows promise for effectively managing depression in teens. ^{1 2 3 6 7}

Who Is on the Research Team?

Darren B Courtney, MD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My doctor and I agree that treating my depression is necessary.

I am between 13 and 18 years old and feel depressed.

Mood and Feelings Questionnaire score is ≥22 at two sequential visits (screening and baseline assessment)

Exclusion Criteria

Youth currently in Day Treatment

I experience ongoing symptoms that affect my thinking and behavior.

Severe substance use disorder, bipolar disorder, autism spectrum disorder, intellectual disability, severe eating disorder, imminent risk of suicide requiring hospitalization

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Integrated Care Pathway (ICP) or Treatment As Usual (TAU) for depression, with a focus on reducing depressive symptoms and improving functioning.

24 weeks

Regular visits for assessment and treatment adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Integrated Care Pathway
• Treatment As Usual

Trial Overview 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.

How Is the Trial Designed?

Group I: CARIBOU-2 Experimental Treatment 1 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 Usual Active Control 1 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.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

An Integrated Care Pathway (ICP) for treating adolescents with Major Depressive Disorder (MDD-A) was developed based on high-quality clinical guidelines, ensuring that treatment reflects the best available evidence.

The ICP includes multi-family psychoeducation, a 16-session Group Cognitive Behaviour Therapy, and regular team reviews, aiming to improve treatment consistency and outcomes for adolescents with depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Way through the woods: Development of an integrated care pathway for adolescents with depression. Courtney, D., Bennett, K., Henderson, J., et al.[2021]

The development and implementation of an integrated care pathway (ICP) for managing depression after brain injury significantly improved documentation standards in a rehabilitation unit, with compliance rates rising to 94-100% for most areas assessed.

The ICP not only enhanced documentation practices but also increased staff awareness of depression management, which may lead to better overall care for patients recovering from brain injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A completed audit cycle and integrated care pathway for the management of depression following brain injury in a rehabilitation setting. Hassan, N., Turner-Stokes, L., Pierce, K., et al.[2019]

The Integrated Care Pathway (ICP) significantly improved symptoms of depression and anxiety, as well as quality of life, in older adults compared to the Treatment-As-Usual (TAU) approach, based on a study of 145 participants over 24 months.

Participants in the ICP group experienced a much faster initiation of treatment, with a hazard ratio of 3.557, indicating they were over three times more likely to start treatment compared to those receiving TAU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Integrated Care Pathways Within the Framework of Collaborative Care on Older Adults With Anxiety, Depression, or Mild Cognitive Impairment. Dham, P., McAiney, C., Saperson, K., et al.[2022]

The implementation of Integrated Care Pathways (ICPs) in managing diabetic ketoacidosis (DKA) led to a significant reduction in the time to start intravenous fluids and insulin infusion, improving the speed of treatment initiation.

There was also a notable decrease in the unnecessary prescription of antibiotics and low molecular weight heparin, indicating a more targeted approach to DKA management after the ICP was introduced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does an integrated care pathway enhance the management of diabetic ketoacidosis? Waller, SL., Delaney, S., Strachan, MW.[2019]

The Integrated Care Pathway (ICP) developed for treating adolescents with depression aims to improve treatment response by following a Clinical Practice Guideline and a measurement-based care framework, with outcomes assessed using the Childhood Depression Rating Scale - Revised (CDRS-R) over a 20-week period.

The study plans to recruit 30 participants at two outpatient sites, with the hypothesis that the ICP will lead to greater reductions in depressive symptoms compared to standard treatment, and if successful, will pave the way for a larger multi-center randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an Integrated Care Pathway for Adolescents with Depression: A Pilot Clinical Trial Protocol. Courtney, DB., Cheung, A., Henderson, J., et al.[2022]

In a study of 82 patients with brain injuries, 50% were identified as having depression and treated with sertraline, showing significant clinical improvement without major side effects.

Notably, 52% of patients who previously did not respond to other SSRIs had a positive response to sertraline, indicating its potential effectiveness in treatment-resistant cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing depression in brain injury rehabilitation: the use of an integrated care pathway and preliminary report of response to sertraline. Turner-Stokes, L., Hassan, N., Pierce, K., et al.[2017]

The implementation of an integrated care pathway (ICP) for 224 patients with schizophrenia aimed to improve collaboration between hospital and community mental health services, but showed minimal effectiveness in reducing re-hospitalization rates or inpatient costs.

Despite efforts to enhance compliance with established procedures during hospitalization, significant disagreements between sectors persisted, indicating that the ICP did not achieve its intended goals and led to the phasing out of ineffective initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The Alliance Programme: an integrated care pathway for patients with schizophrenia]. Nielsen, B., Sigsgaard, A., Gregersen, J., et al.[2019]

The integrated care pathway (ICP) developed for patients with both major depressive disorder and alcohol dependence at CAMH showed high patient satisfaction and effective symptom improvement during its pilot implementation.

The methodology used for the ICP included evidence reviews and process reengineering, which contributed to excellent patient retention in the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Implementation of an Ambulatory Integrated Care Pathway for Major Depressive Disorder and Alcohol Dependence. Awan, S., Samokhvalov, AV., Aleem, N., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6863574/

Effectiveness of an Integrated Care Pathway for Adolescents ... For adolescents with depression, we anticipate that this ICP will lead to better symptom and functional outcomes relative to treatment as usual for this ...

2. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-023-05297-4

An Integrated Care Pathway for depression in adolescents ... Our group developed an Integrated Care Pathway to facilitate the delivery of evidence-based care for adolescents experiencing depression called CARIBOU-2.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03428555

Integrated Care Pathway for Youth Depression Major Depressive Disorder in adolescence is prevalent and debilitating. Our group aims to improve treatment response through the use of an Integrated Care ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40379352/

Protocol for the economic evaluation of the Care ... The objective of this study protocol is to delineate the proposed economic evaluation of an integrated care pathway for depression in adolescents.

5. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/312465

Effectiveness of an Integrated Care Pathway for Depression The primary objective is to establish the clinical effectiveness of the ICP intervention in the community setting relative to TAU, with respect to reducing ...

6. camh.ca camh.ca/-/media/professionals-files/caribou-cbt/caribou-integrated-care-pathway-manual-pdf.pdf

CARIBOU-2 Pathway Manual The CARIBOU-2 Integrated. Care Pathway for Adolescents with Depression: Pathway Manual. Version 2.1. Toronto, ON: Centre for Addiction and ...

7. bmjopen.bmj.com bmjopen.bmj.com/content/15/5/e092541

Protocol for the economic evaluation of the Care ... The objective of this study protocol is to delineate the proposed economic evaluation of an integrated care pathway for depression in adolescents.