Adapting Single Sessions Interventions for Type 1 Diabetes
NCT ID: NCT06752369
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2025-02-28
2029-02-28
Brief Summary
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1. Is a single-session depression intervention for youth with T1D feasible to recruit and implement?
2. Is a single-session depression intervention for youth with T1D acceptable to patients (i.e., do they find it helpful)?
3. Does a single-session depression intervention for youth with T1D lead to improvements in low mood?
Researchers will compare a single-session depression intervention for youth with to a education control to see if a single-session depression intervention works to improve depressive symptoms.
Participants will:
* Participate in a single-session depression intervention
* Complete questionnaires and provide a sample for A1c at a baseline, 3-month, and 6-month visit
* Complete daily questionnaires once a day for two weeks before and after the single-session depression intervention
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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T1D-specific depression SSI
Single session depression intervention adapted for youth with T1D. The T1D-specific depression SSI will include 1) psychoeducation about depression, including how behavior shapes feelings and thoughts, 2) a values assessment, where youth will identify key areas (i.e., family relationships, friendships, school, or hobbies) from which they draw (or once drew) enjoyment and meaning, and 3) the creation of an activity action plan, wherein youth identify (from pre-generated lists) and personalize (in guided exercises) three activities to target for change.
T1D-specific depression SSI
The T1D-specific depression SSI will include 1) psychoeducation about depression, including how behavior shapes feelings and thoughts, 2) a values assessment, where youth will identify key areas (i.e., family relationships, friendships, school, or hobbies) from which they draw (or once drew) enjoyment and meaning, and 3) the creation of an activity action plan, wherein youth identify (from pre-generated lists) and personalize (in guided exercises) three activities to target for change.
T1D Education
Educational material about T1D
T1D Educational
T1D Educational Material
Interventions
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T1D-specific depression SSI
The T1D-specific depression SSI will include 1) psychoeducation about depression, including how behavior shapes feelings and thoughts, 2) a values assessment, where youth will identify key areas (i.e., family relationships, friendships, school, or hobbies) from which they draw (or once drew) enjoyment and meaning, and 3) the creation of an activity action plan, wherein youth identify (from pre-generated lists) and personalize (in guided exercises) three activities to target for change.
T1D Educational
T1D Educational Material
Eligibility Criteria
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Inclusion Criteria
* Physician confirmed T1D diagnosis of at least 6 months duration prior to study enrollment
* Positive depression screening score of \>5 on the PHQ-9 in the last year
* Not currently engaged in outpatient mental healthcare
* English fluency
Exclusion Criteria
* Any score of 1, 2, or 3 on item 9 (indicating suicidal ideation) of the PHQ-9 in the last year.
12 Years
17 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Nemours Children's Health System
OTHER
Responsible Party
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Alexandra Monzon
Assistant Research Scientist
Locations
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Nemours Children's Hospital - FL
Orlando, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Alexandra Monzon, PhD
Role: primary