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Behavioral Intervention

Dialectical Behavioural Therapy for Type 2 Diabetes

N/A

Recruiting

Led By Brandy Wicklow, MD MSc

Research Sponsored by Dr. Brandy Wicklow

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Must not have

History of ever cancer

Diabetes not diagnosed as type 2 diabetes including: type 1 diabetes, genetic diabetes, cystic fibrosis diabetes, diabetes secondary to medication use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year pilot

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to address high rates of kidney disease in Indigenous children living with Type 2 Diabetes by developing a therapy that focuses on mindfulness, personal strengths, and traditional medicine practices. They plan to conduct

Who is the study for?

This trial is for First Nations adolescents aged 14-17 with Type 2 Diabetes. It includes those interested in a program combining Dialectical Behavioural Therapy (DBT) and traditional medicine. Caregivers may also participate. Youth not within the age range or without Type 2 Diabetes are excluded.

What is being tested?

The iCARE 2.0 study tests DBT combined with traditional medicine practices to improve mental wellness, medication adherence, glycemic control, and kidney health in Indigenous youth with T2D. Participants will be randomly assigned to receive either this intervention or be placed in a control group.

What are the potential side effects?

Since the intervention involves therapy and traditional practices rather than drugs, typical medical side effects are not expected; however, emotional discomfort due to personal reflection during therapy sessions could occur.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer in the past.

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My diabetes is not type 2; it could be type 1, genetic, or due to other causes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year pilot

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year pilot

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year pilot for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pediatric Quality of Life (PedsQL)

Study Acceptability

Study Feasibility

Secondary study objectives

Albuminuria

Glycemic Control

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dialectical Behavioural TherapyExperimental Treatment1 Intervention

Participants randomized to the Dialectical Behavioural Therapy (DBT) skills training intervention will receive a 90-minute DBT skills training session every week for 16 weeks total. The sessions will be facilitated by a health practitioner supervised by a clinical health psychologist with expertise in program development and DBT-adaptations for a variety of populations. Sessions for Pilot 1 will be delivered via Zoom HealthCare and in person if allowable. In-person sessions would be delivered at the Children's Hospital Research Institute of Manitoba. Pilot 2 will be adapted to address any additional needs uncovered through he qualitative assessment of Pilot 1. Traditional medicine components will be developed within the first 2 years of the grant by Indigenous researchers, patient and parent advisors, elders, and community advisory groups. These elements will be offered as an encouraged, yet optional component (additional modules) within the 16-week DBT intervention in Pilot 2.

Group II: ControlActive Control1 Intervention

Participants randomized to the control arm will receive standard medical care and clinical follow-up. Controls will be offered DBT after completion of Pilot 1 and 2. Participation will be optional.

0 / 2Eligibility criteria met