Depressive Symptoms, Type 1 Diabetes Mellitus
Conditions
Brief summary
This study evaluates the use of an established internet-based cognitive behavioral therapy intervention in a group of adolescents with type 1 diabetes and mild to moderate depressive symptoms. Half of the participants will receive the internet-based intervention while the other half will receive usual care.
Detailed description
Adolescents with diabetes have a higher incidence of subclinical and clinical depression compared to healthy adolescents. Patients with diabetes who are clinically or subclinically depressed are at high risk for poor glycemic control. Studies evaluating prevention and treatment strategies for depression in patients with type 1 diabetes have shown that group cognitive-behavioral therapy (CBT) and individual interpersonal psychotherapy (IPT) can reduce the risk of depressive illness in adolescents with diabetes. Computerized interventions show evidence of being efficacious, and have been recommended as the first line intervention. The Competent Adulthood Transition with Cognitive Humanistic and Interpersonal Teaching (CATCH-IT) internet program has shown positive results with adolescents at risk for depression, but has not been used in patients with a chronic illness like diabetes. CATCH-IT is based on established CBT and IPT treatment models. It includes a) an innovative and effective brief practitioner-provided motivation enhancement component (in person at enrollment and through phone calls) and b) self-directed modules for the adolescent that can be accessed on the internet.
Interventions
BEHAVIORALCATCH-IT
The CATCH-IT internet program consists of 14 modules and exercises and activities based on best practices components of depression prevention. They will be instructed to complete at least 2 modules a week, over a period of 6 weeks. This would require at least 40 minutes per week (approximately 20 minutes minimum per module).
Sponsors
University of Illinois at Chicago
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized at the baseline visit to the CATCH-IT Intervention or Control group
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age 13-17 receiving ongoing medical care in the Diabetes Clinic at Children's Medical Center Dallas. * Patients must be fluent in English (the materials on the site have not been validated in any other language), be in at least the 8th grade, report/demonstrate comfort with use of a computer, and regular, convenient and discreet access to the internet. * Patients must experience at least sub-threshold depression (CES-D score \> 15). * Patients must have had the diagnosis of type 1 diabetes for at least 12 months.
Exclusion criteria
* Patients who are medically unstable during their diabetes clinic visit will be excluded (i.e. diabetes ketoacidosis, symptomatic hypoglycemia). * Patients who are too severely depressed for this form of intervention (i.e. meet criteria for MDD, endorse suicidal intent, PHQ-A score ≥ 20), those with a diagnosis or symptoms of severe mental illness (schizophrenia, bipolar disorder), prior psychiatric hospitalization, prior self-harm attempt. * Patients receiving ongoing counseling or therapy services within the last year, by a licensed professional (counselor, psychologist or psychiatrist). * Patients who are currently taking or begin taking psychotropic medications during study participation will be excluded/withdrawn.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Center for Epidemiological Studies - Depression Scale (CES-D) | 6 weeks | A screening test for depression and depressive disorder. The CESD measures symptoms defined by the American Psychiatric Association' Diagnostic and Statistical Manual (DSM-V) for a major depressive episode. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 12 weeks | Hemoglobin A1c- a 3-month surrogate marker of diabetes control |
| Patient Health Questionnaire Modified for Teens | 6 weeks and 12 weeks | A self-completion screening questionnaire designed to detect symptoms of depression and suicide risk in adolescents. |
| Problem Areas in Diabetes - Teen version | 6 weeks and 12 weeks | A validated measure of diabetes distress designed specifically for adolescents with type 1 diabetes |
Countries
United States
Outcome results
None listed