Cognitive Adaptations to Reduce Emotional Stress Associated With Type 1 Diabetes (CARES)
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| ClinicalTrials.gov Identifier: NCT03698708 |
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Recruitment Status :
Completed
First Posted : October 9, 2018
Results First Posted : February 11, 2022
Last Update Posted : February 11, 2022
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Type 1 Diabetes Mellitus |
| Intervention |
Behavioral: CARES Intervention |
| Enrollment | 37 |
| Recruitment Details | recruited in clinic, by telephone, and through email |
| Pre-assignment Details | The study recruited parents/caregivers as participants only. Parents gave permission for researchers to collect an HbA1c level for their child. Children did not participate in the treatment. |
| Arm/Group Title | CARES Intervention- 12 Sessions | CARES Intervention- 8 Sessions |
|---|---|---|
 Arm/Group Description |
Participants in the intervention will participate in 12 weekly group-based telemedicine intervention sessions (up to 60 minutes each) with other parents/caregivers of children with T1D. Intervention sessions focus on cognitive-behavioral therapy to treat depression, including identifying cognitive distortions, cognitive restructuring, behavioral activation, coping strategies, and learning diabetes management skills. CARES Intervention: A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach. |
Participants in the intervention will participate in 8 weekly group-based telemedicine intervention sessions (up to 60 minutes each) with other parents/caregivers of children with T1D. Intervention sessions focus on cognitive-behavioral therapy to treat depression, including identifying cognitive distortions, cognitive restructuring, behavioral activation, coping strategies, and learning diabetes management skills. CARES Intervention: A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach. |
| Period Title: Overall Study | ||
| Started | 17 | 20 |
| Completed | 13 | 16 |
| Not Completed | 4 | 4 |
| Arm/Group Title | CARES Intervention- 12 Sessions | CARES Intervention- 8 Sessions | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Participants in the intervention will participate in 12 weekly group-based telemedicine intervention sessions (up to 60 minutes each) with other parents/caregivers of children with T1D. Intervention sessions focus on cognitive-behavioral therapy to treat depression, including identifying cognitive distortions, cognitive restructuring, behavioral activation, coping strategies, and learning diabetes management skills. CARES Intervention: A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach. |
Participants in the intervention will participate in 8 weekly group-based telemedicine intervention sessions (up to 60 minutes each) with other parents/caregivers of children with T1D. Intervention sessions focus on cognitive-behavioral therapy to treat depression, including identifying cognitive distortions, cognitive restructuring, behavioral activation, coping strategies, and learning diabetes management skills. CARES Intervention: A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach. |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 17 | 20 | 37 | |
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Baseline Analysis Population Description |
Primary outcomes were parent report variables: diabetes distress, depressive symptoms, fear of hypoglycemia, treatment satisfaction. As an exploratory variable, we examined children's HbA1c level.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 17 participants | 20 participants | 37 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
17 100.0%
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20 100.0%
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37 100.0%
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| >=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 17 participants | 20 participants | 37 participants | |
| 41.29 (7.49) | 38.25 (6.07) | 39.65 (6.84) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 17 participants | 20 participants | 37 participants | |
| Female |
16 94.1%
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20 100.0%
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36 97.3%
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| Male |
1 5.9%
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0 0.0%
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1 2.7%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 17 participants | 20 participants | 37 participants | |
| Hispanic or Latino |
1 5.9%
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1 5.0%
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2 5.4%
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| Not Hispanic or Latino |
16 94.1%
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19 95.0%
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35 94.6%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 17 participants | 20 participants | 37 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
0 0.0%
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0 0.0%
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0 0.0%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
1 5.9%
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1 5.0%
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2 5.4%
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| White |
15 88.2%
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16 80.0%
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31 83.8%
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| More than one race |
1 5.9%
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2 10.0%
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3 8.1%
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| Unknown or Not Reported |
0 0.0%
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1 5.0%
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1 2.7%
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Problem Areas in Diabetes-PR
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 17 participants | 20 participants | 37 participants | |
| 32.65 (11.87) | 39.69 (14.72) | 36.45 (13.77) | ||
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[1]
Measure Description: This is a validated measure of diabetes distress. Parents/Caregivers completed this measure. Higher scores reflect more distress. Range 0-72.
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Center for Epidemiological Study Depression Scale Revised
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 17 participants | 20 participants | 37 participants | |
| 16.12 (11.21) | 11.25 (11.08) | 13.49 (10.17) | ||
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[1]
Measure Description: This is a measure of depressive symptoms. Parents/Caregivers completed this measure. Higher scores reflect more depressive symptoms. Score range 0-60.
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Hypoglycemia Fear Survey-Parents
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 17 participants | 20 participants | 37 participants | |
| 66.47 (14.12) | 67.95 (16.27) | 67.27 (15.13) | ||
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[1]
Measure Description: This is a measure of hypoglycemia fear. Parents/Caregivers completed this measure. Higher scores reflect greater fear of hypoglycemia. Scores range 25-125.
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| Name/Title: | Dr. Susana Patton |
| Organization: | Nemours Children's Health |
| Phone: | 904-697-2000 |
| EMail: | susana.patton@nemours.org |
| Responsible Party: | University of Kansas Medical Center |
| ClinicalTrials.gov Identifier: | NCT03698708 |
| Other Study ID Numbers: |
R01DK100779-05 ( U.S. NIH Grant/Contract ) |
| First Submitted: | October 3, 2018 |
| First Posted: | October 9, 2018 |
| Results First Submitted: | December 16, 2021 |
| Results First Posted: | February 11, 2022 |
| Last Update Posted: | February 11, 2022 |