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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
Sponsor:
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Depressive Symptoms Behavioral: CATCH-IT Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Intervention
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.
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).

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 12 weeks ]
    Hemoglobin A1c- a 3-month surrogate marker of diabetes control

  2. 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.

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Yasmin Dominguez (214) 456-5362 YASMIN.DOMINGUEZ@childrens.com

Locations
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United States, Texas
Children's Medical Center Not yet recruiting
Dallas, Texas, United States, 75235
Contact: Yasmin Dominguez       YASMIN.DOMINGUEZ@childrens.com   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
University of Illinois at Chicago
Investigators
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Principal Investigator: Olga T Gupta, MD UTSW

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03655067     History of Changes
Other Study ID Numbers: STU 012018-059
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Depression
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Behavioral Symptoms