Supporting Treatment Adherence Needs in Diabetes
Withdrawn before enrolling · Not applicable
Conditions studied: Type 1 Diabetes
In brief
There is an unmet treatment need for depressed adolescents with type 1 diabetes. To address this unmet need, we have designed a new, family-based, cognitive-behavioral intervention to reduce depressive symptoms, improve family functioning, and improve medication compliance. The intervention is delivered in two phases (1 - reduction of depressive symptoms and family conflict, 2 - adherence promotion) as efforts to improve adherence will have a greater likelihood of success if individual and family functioning variables are addressed first. To test the effectiveness of this intervention in reducing depressive symptoms and improving adherence, we will conduct a randomized controlled trial comparing this new intervention to usual care in a sample of fifty-two adolescents with type 1 diabetes and their primary caregivers. Given the absence of this type of intervention and the significance of the problem, this study is timely and important, as it has the potential to positively impact diabetes-specific health outcomes.
Key facts
- Study ID
- NCT01030471
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 0
- Starts
- 2009-09-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2020-09-14
Who can join
Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 13-17
- Diagnosis of type 1 diabetes according to criteria from the ADA for at least 1 year
- Daily insulin dosing of at least 0.5 units per kilogram per day
- Clinical elevation on the CDI (i.e., score at or above 13)
- Assent to participation in study
You may not qualify if…
- Other chronic, physical disease or condition except for celiac or thyroid disease
- Diagnosis of major mental disorder (e.g., bipolar disorder, thought disorder, anorexia nervosa)
- Diagnosis of developmental disorder (e.g., mental retardation, autism, Asperger's)
- Current enrollment in psychotherapy specifically targeting depression
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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