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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the Integrated Care Pathway treatment for depression?

Research shows that Integrated Care Pathways (ICPs) can improve treatment for depression by using evidence-based guidelines and involving a team of healthcare providers. Studies have found that ICPs help manage depression in various settings, such as after brain injury and in older adults, by improving care standards and patient outcomes. ^{1 2 3 4 5}

Is the Integrated Care Pathway generally safe for humans?

The Integrated Care Pathway (ICP) has been used in various settings, including for adolescents with depression and patients with major depressive disorder and alcohol dependence, with reports of high patient satisfaction and symptom improvement, suggesting it is generally safe. ^{1 2 3 4 6}

How is the Integrated Care Pathway treatment for depression different from other treatments?

The Integrated Care Pathway (ICP) for depression is unique because it combines evidence-based guidelines with a structured plan to ensure consistent and optimal care. It involves a multidisciplinary approach, meaning different healthcare professionals work together to provide comprehensive treatment, which is not always the case with standard care. ^{1 2 3 7 8}

Research Team

Darren B Courtney, MD

Principal Investigator

University of Toronto

Eligibility Criteria

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.

Inability to provide informed consent for any reason

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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 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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of an Integrated Care Pathway for Adolescents with Depression: A Pilot Clinical Trial Protocol. [2022]

2. England 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. [2019]

3. Australia pubmed.ncbi.nlm.nih.gov

A Way through the woods: Development of an integrated care pathway for adolescents with depression. [2021]

4. England 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. [2017]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Development and Implementation of an Ambulatory Integrated Care Pathway for Major Depressive Disorder and Alcohol Dependence. [2015]

7. Denmark pubmed.ncbi.nlm.nih.gov

[The Alliance Programme: an integrated care pathway for patients with schizophrenia]. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Does an integrated care pathway enhance the management of diabetic ketoacidosis? [2019]