RecruitingNAINTERVENTIONAL

Pragmatic Patient-oriented Extension Study of Dialectical Behavior Therapy Booster Sessions for Youth With and/or at Familial Risk for Bipolar Disorder

This study is for young people between 14 and 25 years old who have bipolar disorder, or a close family member with it. Participants will have already completed a full year of a talking therapy called Dialectical Behaviour Therapy (DBT) in a previous study. This new study explores 'booster' sessions, which are extra support to help people continue using the skills they learned in DBT. These boosters can be individual or group sessions, and might even include phone calls with a coach, depending on what works best for the participant and their therapist. The aim is to understand how these flexible extra sessions can help young people manage their condition over time, giving them a say in their ongoing care.

At a glance

Status

Recruiting

Phase

Sponsor

Centre for Addiction and Mental Health

Enrolment target

120

Start

09 Nov 2022

Estimated completion

30 Nov 2028

Bipolar Disorder

What is this study about?

This research is looking into how extra support sessions, sometimes called 'booster' sessions, can help young people who have bipolar disorder or who have family members with it. If you've already finished a year of a specific type of talking therapy called Dialectical Behaviour Therapy (DBT) in a previous study, this research might be for you. DBT is a well-known therapy that helps people learn skills to manage their emotions and relationships.

The main idea of this study is to see how these ongoing, flexible sessions can best support young people. Instead of a set plan, you'll work with your therapist to decide how many sessions you need and what kind of support is most helpful for you. This could involve one-on-one chats, group skills sessions, or even phone calls with a coach for extra support between appointments. The study wants to understand how giving young people a bigger say in their care can help them continue to use the skills they've learned.

There isn't another therapy being compared against these booster sessions in this study. The goal is simply to understand how this flexible, personalised approach to continued DBT support can benefit young people who have already completed the initial year-long programme. It's about finding the best way to help you maintain your well-being and use your skills as you move forward.

Key takeaways

Looks at flexible, ongoing DBT support for young people with bipolar disorder.
For those who've completed a year of DBT in a previous study.
You and your therapist decide how many and what type of 'booster' sessions you need.
Aims to help you continue using skills to manage your health.
Not testing new drugs, focuses on therapy support.
Aged 14-25, English speaking, and specific diagnostic criteria apply.

Who may be eligible?

To join this study, you need to be aged between 14 and 25 years old and speak English. You must have already completed a year-long programme of Dialectical Behaviour Therapy (DBT) as part of a previous research study.

Another important requirement is that you either have a diagnosis of bipolar disorder yourself, or you have a parent or sibling with bipolar disorder. If you have bipolar disorder type 1, you also need to be taking at least one mood-stabilising medication, such as an anticonvulsant, antipsychotic, or lithium, and be regularly seeing a psychiatrist for your care.

There are also some reasons why you might not be able to join. For example, if you have a serious medical condition needing urgent treatment, or if you're currently experiencing sexual or physical abuse. Also, if you have certain severe learning difficulties or conditions like moderate to severe autism that might make it hard to take part actively in the therapy, you wouldn't be able to join this particular study. The study also excludes those with current severe drug or alcohol problems, though mild cannabis or alcohol use may be allowed.

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 14 and 25 years old?
Have you finished a full year of DBT in a past research study?
Do you speak English?
Do you have bipolar disorder, or does a parent or sibling have it?
If you have Bipolar I, are you taking a mood-stabilising medicine and seeing a psychiatrist?
Are you able and willing to agree to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be receiving 'booster' sessions of Dialectical Behaviour Therapy (DBT). These aren't rigidly set, meaning you and your therapist will work together to decide how many sessions you need and how often. These could be individual one-to-one sessions, group sessions where you practice skills with others, and you might also get phone calls from a coach for support between sessions. The study does not specify an end date or total duration for these booster sessions, as the frequency is decided by you and your therapist. There are no particular assessments mentioned beyond your therapeutic interactions, and no specific medications are being provided or managed by the study, other than requiring those with Bipolar I to continue their prescribed mood stabilisers.

Potential risks and benefits

Taking part in this study may offer the benefit of continued, flexible support for managing bipolar disorder symptoms and maintaining the skills you learned in DBT, tailored specifically to your needs. This could help you feel more in control of your well-being. As with any therapy, there might be times when discussing feelings or experiences could be challenging, but your therapist is there to support you. There are no new medications or experimental procedures involved, as it focuses on an established therapy. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Common questions

What is Dialectical Behaviour Therapy (DBT)?

DBT is a type of talking therapy that helps people learn skills to manage strong emotions, cope with distress, and improve their relationships with others.

What are 'booster' sessions?

Booster sessions are extra therapy sessions designed to help you continue practicing and using the skills you learned in your main DBT course, providing ongoing support.

How often would I have sessions?

You and your therapist will decide together how often you have sessions, based on what you feel you need. It's a very flexible approach.

Will I have to take any new medicines?

No, this study is about therapy sessions, not new medicines. If you have Bipolar I, you'll continue any mood-stabilising medication your doctor has already prescribed.

What if I feel uncomfortable or want to leave the study?

You can leave the study at any time, for any reason. Your decision will not affect your ongoing medical care.

How to find out more

Vanessa Rajamani, MSW

vanessa.rajamani@camh.ca 416-535-8501 Official trial record

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