Back to resultsInternet-Based Cognitive Behavioral Therapy for Depressive Symptoms in Adolescents With Type 1 Diabetes Mellitus
Primary Purpose
Type 1 Diabetes Mellitus, Depressive Symptoms
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CATCH-IT
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
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Patients who are currently taking or begin taking psychotropic medications during study participation will be excluded/withdrawn.
Sites / Locations
- Children's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Usual Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Hemoglobin A1c
Hemoglobin A1c- a 3-month surrogate marker of diabetes control
Patient Health Questionnaire Modified for Teens
A self-completion screening questionnaire designed to detect symptoms of depression and suicide risk in adolescents.
Problem Areas in Diabetes - Teen version
A validated measure of diabetes distress designed specifically for adolescents with type 1 diabetes
Full Information
NCT ID
NCT03655067
First Posted
August 21, 2018
Last Updated
August 22, 2022
Sponsor
University of Texas Southwestern Medical Center
Collaborators
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT03655067
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
University of Illinois at Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Depressive Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized at the baseline visit to the CATCH-IT Intervention or Control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CATCH-IT
Intervention Description
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).
Primary Outcome Measure Information:
Title
Center for Epidemiological Studies - Depression Scale (CES-D)
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Hemoglobin A1c
Description
Hemoglobin A1c- a 3-month surrogate marker of diabetes control
Time Frame
12 weeks
Title
Patient Health Questionnaire Modified for Teens
Description
A self-completion screening questionnaire designed to detect symptoms of depression and suicide risk in adolescents.
Time Frame
6 weeks and 12 weeks
Title
Problem Areas in Diabetes - Teen version
Description
A validated measure of diabetes distress designed specifically for adolescents with type 1 diabetes
Time Frame
6 weeks and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga T Gupta, MD
Organizational Affiliation
UTSW
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Internet-Based Cognitive Behavioral Therapy for Depressive Symptoms in Adolescents With Type 1 Diabetes Mellitus
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