RecruitingNAINTERVENTIONAL

iCARE 2.0: A Pilot Intervention of Dialectical Behavioural Therapy for Youth With Type 2 Diabetes.

The iCARE 2.0 study is testing a special type of talking therapy called Dialectical Behavioural Therapy (DBT) for young people aged 14 to 22 who have Type 2 Diabetes. This therapy aims to help them with their overall wellbeing, kidney health, and how well they manage their diabetes. The study is also exploring how including traditional Indigenous medicine practices could make the therapy even more helpful, especially for Indigenous youth. The researchers want to see if this combined approach is something young people will want to take part in and find useful. The results will help plan a bigger study in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Dr. Brandy Wicklow

Enrolment target

Start

21 Nov 2022

Estimated completion

31 Mar 2026

Diabetes Mellitus Type 2, Childhood-Onset

What is this study about?

This study, called iCARE 2.0, is looking at new ways to help young people in the UK who have Type 2 Diabetes. The main idea is to see if a special kind of talking therapy, known as Dialectical Behavioural Therapy (DBT), can improve their health and well-being. DBT helps people learn new skills to manage difficult emotions and improve their relationships, which can be very useful when dealing with a long-term health condition like diabetes.

The researchers are particularly interested in how this therapy might help prevent kidney problems, which can be a serious complication of Type 2 Diabetes, especially in Indigenous children. They are also exploring how traditional Indigenous medicine practices and teachings could be included in the therapy to make it more meaningful and helpful for these young people. This study is an important step towards developing a new, supportive approach to diabetes care that considers both modern therapy and traditional wisdom.

This is a pilot study, meaning it's a small-scale trial to see how well the therapy works and if it's something people want to take part in. The researchers will be looking at how many young people join, how consistently they attend, and what they think about the therapy. This information will help them plan a larger study in the future to confirm if this new approach can truly make a difference in the lives of young people with Type 2 Diabetes.

Key takeaways

This study explores a new therapy (DBT) for young people with Type 2 Diabetes.
It aims to improve diabetes management, kidney health, and overall well-being.
Traditional Indigenous medicine practices are being considered for inclusion.
Participation involves online group therapy sessions for 16 weeks and follow-up checks.
It's a pilot study, meaning it's a smaller first step towards a larger research project.
You can withdraw from the study at any time.

Who may be eligible?

The study is looking for young people aged 14 to 22 years old who have been diagnosed with Type 2 Diabetes.

Unfortunately, you wouldn't be able to join if you have other types of diabetes, such as Type 1 Diabetes, or if your diabetes is caused by other medical conditions or medicines. You also can't take part if you have certain other long-term illnesses that affect your whole body, have had cancer, or have a significant mental health condition like an active psychotic disorder, or have attempted suicide recently. The study also cannot accept pregnant individuals or those with significant self-harm or substance use issues that would make it difficult to participate fully in the group sessions.

It's important that you, and your parent or guardian if you're under 18, are able and willing to give your agreement to take part in the study. All these rules are in place to make sure the study is safe for everyone involved and that the results are clear.

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 22 years old?
Have you been diagnosed with Type 2 Diabetes (and not Type 1 or other types)?
Are you free from certain other long-term illnesses or recent mental health crises?
Are you, and your parent/guardian if applicable, willing to agree to take part?
Are you able to participate in therapy sessions and don't have issues that would prevent it?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you and a family member will either join a group for Dialectical Behavioural Therapy (DBT) or be part of a comparison group. Those in the DBT group will attend regular group sessions for about 16 weeks, which will take place online via Zoom. Before the therapy starts, at the end of the 16 weeks, and again three months later, you'll be asked to complete some questionnaires to see how you're doing.

Some participants in the DBT group, along with their parents or guardians, will also be asked to have a one-on-one interview after the 16-week program finishes. This will give you a chance to share your thoughts and experiences more deeply. The study will run for a total of at least 3 months, not including the initial 16-week therapy period.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that you might learn new skills through Dialectical Behavioural Therapy that could help you manage your diabetes and overall well-being. There's also the satisfaction of contributing to important research that could help other young people with Type 2 Diabetes in the future. Potential risks might include the time commitment required for the sessions and assessments, and discussing personal experiences during therapy might sometimes feel challenging. However, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Clinic Y, Health Sciences Centre
Verified postcode
Winnipeg, Canada· Recruiting
Diabetes Education Resource Centre for Adolescents Clinic, Health Sciences Centre
Verified postcode
Winnipeg, Canada· Recruiting

Common questions

What is Dialectical Behavioural Therapy (DBT)?

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

Will I have to pay to join this study?

No, taking part in this research study will not cost you anything.

How long will the study last if I join?

The group therapy lasts for 16 weeks, and then there are follow-up checks for 3 months after that, so the main part of the study will last about 7 months.

What if I don't like being in the study after I start?

You are free to leave the study at any time, for any reason, without having to explain why.

Will my regular diabetes care change if I join?

The study is designed to add to your current care; it shouldn't replace or change your usual diabetes treatment.

How to find out more

Brandy Wicklow, MD MSc

bwicklow@hsc.mb.ca 2047871222 Official trial record

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