Internet-Based Cognitive Behavioral Therapy for Depressive Symptoms in Adolescents With Type 1 Diabetes Mellitus

Not Applicable

Completed

• Conditions: Depressive Symptoms; Type 1 Diabetes Mellitus
• Interventions: Behavioral: CATCH-IT

• Registration Number: NCT03655067
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Study Start: 2020-12-15
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-22
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	CATCH-IT	The participants in the Intervention group will receive the CATCH-IT program which consists of a motivational component and the internet program for the adolescent. The participants in the Intervention group will receive motivational interviewing at their baseline visit as well as motivational coaching with safety phone calls during weeks 1-6.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Hemoglobin A1c	12 weeks	Hemoglobin A1c- a 3-month surrogate marker of diabetes control

Trial Locations

Locations (1)

Children's Medical Center; 🇺🇸 Dallas, Texas, United States