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Official title Dialectal Behaviour Therapy to Enhance Health Behaviour Change for Adolescents Living With Obesity (DIRECTION Trial)
ClinicalTrials.gov ID: NCT05338944
What this study is testing
- What it's testing
- This research is being conducted to evaluate emotion-focused therapy that incorporates elements of mindfulness, distress tolerance, and relationship support. The investigators want to learn if this therapy, called Dialectical Behavioral Therapy (DBT) will help improve quality of life and weight management in youth at risk for type 2 diabetes.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 17. Healthy volunteers may be eligible.
You may be able to join if
- 14-17 years old
- BMI z-score \>1.4
- signs of mild-moderate depression (PHQ-9 score 5-19)
- willing and able to comply with study procedures
You likely can't join if
- more than one health co-morbidity
- being treated with medication for obesity
- taking steroids
- currently being treated for atypical antipsychotics
- have an orthopedic injury or chronic illness that would prevent them from performing the intervention
- experienced weight loss or enrolled in weight loss program in the six months prior to the study
See the full eligibility criteria
- 14-17 years old
- BMI z-score \>1.4
- signs of mild-moderate depression (PHQ-9 score 5-19)
- willing and able to comply with study procedures
- more than one health co-morbidity
- being treated with medication for obesity
- taking steroids
- currently being treated for atypical antipsychotics
- have an orthopedic injury or chronic illness that would prevent them from performing the intervention
- experienced weight loss or enrolled in weight loss program in the six months prior to the study
- they are currently and/or in the past 12 months have been prescribed any weight loss medication(s) including Ozempic
- self reported history of alcoholism or drug abuse
- history of self-harm or suicide attempts in the past 12 months
- currently enrolled in psychotherapy or DBT
- parents do not approve of you participating
- unable to read, speak and understand English as translation will not be provided
- unable/unwilling to give assent/consent
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Winnipeg, Manitoba, Canada
- Hamilton, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 17 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Winnipeg, Manitoba, Canada; Hamilton, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.