RecruitingNAINTERVENTIONAL

Three-level Model of DBT-informed Care for Youth With and/or at Familial Risk for Bipolar Disorder (DB3)

This study explores a new way to offer therapy for young people aged 13 to 23 who have bipolar disorder or have a close family member with it. Instead of a 'one-size-fits-all' approach, the research team wants to see if offering different levels of Dialectical Behaviour Therapy (DBT)-inspired care is more effective. Some young people might need all of the therapy, while others might benefit from less intense support. The study will look at how well these different levels work and factors that might lead to changing the amount of therapy over time, like how a young person is feeling or what they prefer.

At a glance

Status

Recruiting

Phase

Sponsor

Centre for Addiction and Mental Health

Enrolment target

Start

01 Nov 2021

Estimated completion

01 Mar 2026

Bipolar Disorder

What is this study about?

This study is looking into new ways to help young people who have bipolar disorder or are at higher risk of developing it because a parent or sibling has it. Bipolar disorder can be really tough for teenagers, sometimes leading to difficulties with school, friends, and even thoughts of self-harm. While there are already good treatments, this study wants to see if we can make them even better by being more flexible.

Imagine you have a cough. Sometimes you might just need a lozenge, but other times you might need stronger medicine. This study is applying a similar idea to therapy. It's exploring whether offering different 'doses' or levels of therapy, based on what each young person needs and wants, can be more effective. Some young people might need a lot of support, while others might do well with less intensive therapy, especially if they're just starting to show signs or want less frequent sessions.

The therapy style being looked at is inspired by Dialectical Behaviour Therapy (DBT), which helps people manage strong emotions and improve relationships. The study will try out three different levels of this therapy. Researchers want to understand if these different levels work well, and what things (like how a young person is coping or what they prefer) might lead to changing the amount of therapy they receive. This approach hopes to create more personalised care that fits each young person better.

Key takeaways

Exploring flexible therapy amounts for young people with bipolar disorder.
Using a DBT-inspired approach to help manage emotions.
Tailoring therapy intensity to individual needs and preferences.
Aims to understand what level of care works best for different young people.
Focuses on young people aged 13-23 with or at risk of bipolar disorder.

Who may be eligible?

This study is open to young people generally between 13 and 23 years old. To take part, you'd need to speak English. You would also either have a diagnosis of bipolar disorder yourself or have a parent or sibling with bipolar disorder.

If you have bipolar disorder, and it's Type I, you'd need to be taking at least one mood-stabilising medication, and already be seeing a psychiatrist regularly. You'd also need to be able to understand and agree to take part in the study.

There are a few reasons you might not be able to join. For example, if you have certain learning difficulties or a serious medical condition that needs urgent treatment. Also, if you're currently experiencing severe addiction issues (other than mild cannabis or alcohol use) or if you're already in a very high level of care for your mental health concerns, this study might not be the right fit.

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 23 years old?
Do you speak English?
Do you have bipolar disorder, or does a parent or sibling have it?
Are you able to agree to take part in a study?
If you have Bipolar I, are you taking a mood-stabilising medication and seeing a psychiatrist?
Do you have any severe learning difficulties, serious medical conditions, or severe addiction issues (other than mild cannabis/alcohol use)?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be part of a research programme looking at different levels of therapy. You will receive one of three different intensity levels of therapy, which will involve varying numbers and frequencies of sessions. These sessions will be inspired by Dialectical Behaviour Therapy (DBT) principles. Your parents may also be involved in some parts of the treatment. There will be initial assessments to understand your situation, and then ongoing check-ups to see how you're doing and if the level of therapy needs to change. The study will involve regular meetings, tracking your progress, and possibly completing questionnaires. The full duration of your participation will depend on the therapy level you receive and how your needs change over time.

Potential risks and benefits

Participating in this study might offer you the benefit of receiving tailored therapy that's specifically designed to meet your individual needs, rather than a standard approach. This personalised 'dosing' of therapy could potentially lead to better management of your emotional well-being and symptoms. As with any therapy, there might be times when talking about difficult feelings can be challenging, but the therapy is provided by trained professionals. Remember, your participation is voluntary, and you are free to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

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

Common questions

What is 'bipolar disorder'?

Bipolar disorder is a mental health condition that affects your mood, causing extreme shifts from very high (mania) to very low (depression).

What is DBT?

DBT stands for Dialectical Behaviour Therapy. It's a type of therapy that helps people learn skills to manage strong emotions, cope with stress, and improve relationships.

What does 'different levels of care' mean?

It means the study offers different amounts or intensities of therapy, so some young people might have more frequent or longer sessions, while others might have fewer.

Will I have to take new medicine?

This study is focused on therapy, not new medications. If you have Type I bipolar disorder and are already taking mood stabilisers, you will continue your current medication as prescribed by your doctor.

How long will the study last?

The exact length of time you'd be involved can vary, as it depends on the level of therapy you receive and your individual progress, but it will involve ongoing assessments.

How to find out more

Amanda Moss, MSW

amanda.moss@camh.ca 416-535-8501 Official trial record

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