Single Session Intervention for Type 1 Diabetes
(ASSISTED Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to learn if implementing a single-session depression intervention for youth with type 1 diabetes (T1D) is feasible and acceptable to patients. can help improve mood and health outcomes. It will also learn about the initial efficacy of the intervention. The main questions it aims to answer are: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
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
How is the T1D-specific depression SSI treatment different from other treatments for type 1 diabetes-related depression?
What data supports the effectiveness of the treatment T1D-specific depression SSI for type 1 diabetes?
Are You a Good Fit for This Trial?
This trial is for young people with Type 1 Diabetes (T1D), including those who may be experiencing low mood or depression. Participants should be willing to attend a single-session intervention, fill out questionnaires, and provide A1c samples over a period of six months.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single-session Intervention
Participants engage in a single-session depression intervention adapted for youth with T1D, including psychoeducation, values assessment, and activity action plan creation
Daily Questionnaire Phase
Participants complete daily questionnaires once a day for two weeks before and after the single-session depression intervention
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, 3-month, and 6-month visits
What Are the Treatments Tested in This Trial?
Interventions
- T1D-specific depression SSI
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nemours Children's Health System
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator