Dialectal Behaviour Therapy to Enhance Health Behaviour Change for Adolescents Living With Obesity (DIRECTION Trial)
Recruiting · NCT05338944 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Manitoba
View the official record on ClinicalTrials.gov →Interventions studied
Dialectical behavioral therapyLifestyle
What this trial is about
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. Individuals will be randomly assigned to weekly group based session in one of 3 intervention arms; lifestyle + DBT, lifestyle alone, or a control arm.
Who can take part
Age range
14 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion 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
Exclusion criteria
- 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
Where it is running
3 locations listed.
- University of Calgary - Calgary, Alberta, Canada
- University of Manitoba - Winnipeg, Manitoba, Canada
- McMaster University - Hamilton, Ontario, Canada