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

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03655067
• Other study ID #: STU-2020-0230
• Status: Completed
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: August 2022
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• CATCH-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).

Locations

Country	Name	City	State
United States	Children's Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Center for Epidemiological Studies - Depression Scale (CES-D)	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.	6 weeks
Secondary	Hemoglobin A1c	Hemoglobin A1c- a 3-month surrogate marker of diabetes control	12 weeks
Secondary	Patient Health Questionnaire Modified for Teens	A self-completion screening questionnaire designed to detect symptoms of depression and suicide risk in adolescents.	6 weeks and 12 weeks
Secondary	Problem Areas in Diabetes - Teen version	A validated measure of diabetes distress designed specifically for adolescents with type 1 diabetes	6 weeks and 12 weeks