RecruitingNAINTERVENTIONAL

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

This research is investigating a new and organised approach to care for young people aged 13 to 18 who are experiencing depression. Called CARIBOU-2, this special care plan is being compared to the existing 'treatment as usual' provided in community mental health services across the UK. The main aim is to find out if CARIBOU-2 is more effective at reducing depression symptoms. Researchers will also look at how it affects young people's daily activities and if their parents or carers notice improvements. An important part of the study is also to understand how easy or difficult it is to put this new care plan into practice, including its costs and if it's acceptable to patients and staff.

At a glance

Status

Recruiting

Phase

Sponsor

Centre for Addiction and Mental Health

Enrolment target

300

Start

01 Feb 2022

Estimated completion

30 Sep 2027

Major Depressive Disorder

What is this study about?

Depression can be really tough for teenagers, sometimes making it hard to manage everyday life and even putting them at risk. While we know there are good ways to treat depression, not all clinics consistently use the very best, up-to-date methods. This study is all about trying to improve that.

Researchers have designed a new, organised way of delivering care called an 'Integrated Care Pathway' (ICP). Think of it like a clear, step-by-step guide for mental health professionals to follow, based on the latest evidence of what works best. This particular care plan is named CARIBOU-2, and it’s been developed to make sure teenagers with depression get the most effective treatments consistently. The study wants to see if CARIBOU-2 helps young people feel better and live more fulfilling lives compared to the care they usually receive.

The main goal of this research is to see if CARIBOU-2 actually makes a bigger difference in reducing depression symptoms for teenagers aged 13 to 18. It's being tested in regular community mental health clinics, rather than specialist research centres, to see if it works well in everyday settings. The study will also look at whether CARIBOU-2 helps teenagers improve their daily functioning, like doing well at school or with friends, and if parents or carers notice positive changes in their child's mood and behaviour. Finally, the researchers will check how practical, affordable, and well-liked CARIBOU-2 is by both young people and the staff providing the care.

Key takeaways

This study evaluates a new, organised depression care plan (CARIBOU-2) for teenagers.
It compares CARIBOU-2 with standard care provided in local mental health clinics.
The main goal is to see which approach is better at reducing depression symptoms in 13-18 year olds.
Researchers will also look at improvements in daily functioning and how practical the new care plan is.
Participation helps improve future care for young people with depression.

Who may be eligible?

This study is looking for teenagers who are between 13 and 18 years old. You might be suitable if you, or a parent or carer, have expressed concerns about depression, and a mental health professional agrees that your depression symptoms are something that could be helped by treatment.

To join, you should be fairly new to the mental health service (having started within the last three months) or not have had any treatment there for at least three months. There is also a specific score on a questionnaire about moods and feelings that you'd need to meet at two separate appointments.

However, some conditions might mean this study isn't right for you. This includes if you have serious mental health issues like certain forms of psychosis, severe difficulties with drugs or alcohol, bipolar disorder, autism spectrum disorder, or an intellectual disability. You also can't join if you have a severe eating disorder, are at immediate risk of needing hospital care because of suicide concerns, or are currently in a day treatment programme.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 13 and 18 years old?
Are you or your parent/carer concerned about depression?
Has a mental health professional agreed that your depression symptoms are a focus for treatment?
Have you started attending this mental health service within the last 3 months, or not had treatment there for 3 months?
Do you not have certain other serious mental health conditions or risks that would exclude you?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be one of over 600 teenagers involved. The study will take place at your local mental health clinic. All clinics will start by providing 'treatment as usual', and then, at different times, they will switch over to using the new CARIBOU-2 care plan. This means you might receive either the usual care or the new CARIBOU-2 care, depending on when you join and when your clinic switches.

Your progress will be checked regularly. This will involve filling out questionnaires about your depression symptoms. Your mental health professional will also assess how you're doing, and your parent or carer will be asked to share their observations about your mood and behaviour. Researchers will compare how your symptoms change over a 24-week period. There are no specific medications provided by the study, but you will receive care either through the usual approach or the new CARIBOU-2 plan, which might include approved treatments for depression.

Potential risks and benefits

Taking part in any research has potential benefits and risks. A potential benefit of this study is that you might receive care that is more effective for your depression, either through the improved regular care or the new CARIBOU-2 plan. Your participation also helps mental health services understand better ways to support young people with depression in the future. As with any treatment, there's always a chance that the care might not help as much as hoped, or you might not feel better. Your care will be overseen by your usual mental health professionals. You are free to withdraw from the study at any time without giving a reason, and this will not affect your ongoing medical care.

Locations (1)

Centre for Addiction and Mental Health
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is 'depression' in this study?

In this study, 'depression' refers to feeling persistently sad, losing interest in activities, and other symptoms that make daily life difficult for teenagers, as recognised by you, your family, and your doctor.

What is 'Treatment As Usual' (TAU)?

TAU simply means the standard care and treatments for depression that your local mental health service usually provides to young people.

What is CARIBOU-2?

CARIBOU-2 is a new, organised and step-by-step approach to help mental health professionals provide the most effective and up-to-date treatments for teenage depression.

Will I get paid to be in this study?

The information provided doesn't mention any payments for participants. Your participation helps advance understanding of depression care.

Who will know I’m in the study?

Your involvement in the study will be kept confidential within the research team and your care providers, in line with privacy regulations.

How to find out more

Michelle U Ferreira, MEd

michelle.ferreira@camh.ca 4165358501 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.