Clinical trial NCT03655067: Internet-Based Cognitive Behavioral Therapy for Depressive Symptoms in Adolescents With Type 1 Diabetes Mellitus
Official title: Use of an Internet-Based Cognitive Behavioral Therapy Intervention (CATCH-IT) for the Treatment of Depressive Symptoms in Adolescents With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Depressive Symptoms
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
First posted: 2018-08-31
Enrollment: 19
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized at the baseline visit to the CATCH-IT Intervention or Control group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Center for Epidemiological Studies - Depression Scale (CES-D)
timeFrame: 6 weeks
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: 12 weeks
measure: Patient Health Questionnaire Modified for Teens
timeFrame: 6 weeks and 12 weeks
measure: Problem Areas in Diabetes - Teen version
timeFrame: 6 weeks and 12 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Children's Medical Center
state: Texas
Study officials:
affiliation: UTSW
name: Olga T Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References: