Internet-Based Cognitive Behavioral Therapy for Depressive Symptoms in Adolescents With Type 1 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT03655067|
Recruitment Status : Not yet recruiting
First Posted : August 31, 2018
Last Update Posted : February 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus Depressive Symptoms||Behavioral: CATCH-IT||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomized at the baseline visit to the CATCH-IT Intervention or Control group|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||April 2019|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||December 2019|
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.
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).
No Intervention: Usual Care
Participants in the Usual Care group may undergo an evaluation with the Social Worker if the clinician determines that it is necessary. The participants in the Usual Care group will also receive motivational coaching with safety phone calls during weeks 1-6.
- Center for Epidemiological Studies - Depression Scale (CES-D) [ Time Frame: 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.
- Hemoglobin A1c [ Time Frame: 12 weeks ]Hemoglobin A1c- a 3-month surrogate marker of diabetes control
- Patient Health Questionnaire Modified for Teens [ Time Frame: 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 [ Time Frame: 6 weeks and 12 weeks ]A validated measure of diabetes distress designed specifically for adolescents with type 1 diabetes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03655067
|Contact: Yasmin Dominguez||(214) 456-5362||YASMIN.DOMINGUEZ@childrens.com|
|United States, Texas|
|Children's Medical Center||Not yet recruiting|
|Dallas, Texas, United States, 75235|
|Contact: Yasmin Dominguez YASMIN.DOMINGUEZ@childrens.com|
|Principal Investigator:||Olga T Gupta, MD||UTSW|