Single Session Intervention for Type 1 Diabetes

(ASSISTED Trial)

Overseen By Alexandra Monzon, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Nemours Children's Health System

Disqualifiers: Chronic illness, Suicidal ideation, others

Compensation: Varies

Number of Visits: 4

80 Participants Needed

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?

The T1D-specific depression SSI treatment is unique because it is a single-session intervention specifically designed to address depression in people with type 1 diabetes, unlike traditional treatments that may require multiple sessions or are not tailored to diabetes-specific issues. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment T1D-specific depression SSI for type 1 diabetes?

Research shows that depression in people with type 1 diabetes is linked to poorer blood sugar control and less frequent blood sugar monitoring. Treating depression might help improve self-care and blood sugar outcomes. ^{5 6 7 8 9}

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

I have been diagnosed with Type 1 Diabetes for at least 6 months.

Positive depression screening score of >5 on the PHQ-9 in the last year

Not currently engaged in outpatient mental healthcare

Exclusion Criteria

Any score of 1, 2, or 3 on item 9 (indicating suicidal ideation) of the PHQ-9 in the last year.

I have a chronic illness, but it's not celiac disease, autoimmune thyroiditis, microalbuminuria, hypertension, or well-managed asthma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

1 day

1 visit (in-person)

Daily Questionnaire Phase

Participants complete daily questionnaires once a day for two weeks before and after the single-session depression intervention

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, 3-month, and 6-month visits

6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• T1D-specific depression SSI

Trial Overview The study tests if a one-time educational session focused on depression can improve the mood and health outcomes of youths with T1D. It compares this approach against regular diabetes education to see which is more effective in reducing depressive symptoms.

How Is the Trial Designed?

Group I: T1D-specific depression SSI Experimental Treatment 1 Intervention

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.

Group II: T1D Education Placebo Group 1 Intervention

Educational material about T1D

Who Is Running the Clinical Trial?

Nemours Children's Health System

Lead Sponsor

Trials

11

Recruited

17,400+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Psychological interventions, such as counseling and cognitive behavior therapy, significantly reduced glycated hemoglobin levels in children and adolescents with type 1 diabetes, indicating improved glycaemic control.

In contrast, these psychological therapies did not show a significant effect on glycaemic control in adults with type 1 diabetes, although they did help reduce psychological distress in younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological interventions to improve glycaemic control in patients with type 1 diabetes: systematic review and meta-analysis of randomised controlled trials. Winkley, K., Ismail, K., Landau, S., et al.[2022]

Both the OnTrack (emotion-focused) and KnowIt (educational/behavioral) interventions significantly reduced diabetes distress (DD) among 301 adults with type 1 diabetes, with an effect size indicating a strong impact, but no significant differences in effectiveness between the two methods.

While both interventions led to modest improvements in glycemic control (HbA1c), the reduction in DD was only weakly associated with changes in HbA1c, suggesting that addressing emotional and cognitive factors is crucial for effective diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

T1-REDEEM: A Randomized Controlled Trial to Reduce Diabetes Distress Among Adults With Type 1 Diabetes. Fisher, L., Hessler, D., Polonsky, WH., et al.[2022]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

Association between symptoms of depression, diabetes complications and vascular risk factors in four European cohorts of individuals with type 1 diabetes - InterDiane Consortium. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Course of screening-based depression in young adults with a long type 1 diabetes duration: Prevalence and transition probabilities - A cohort study. [2022]

3. Denmark pubmed.ncbi.nlm.nih.gov

Depressive symptoms predict change in glycemic control in adolescents with type 1 diabetes: rates, magnitude, and moderators of change. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Depression in adults in the T1D Exchange Clinic Registry. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Glycemic outcomes related to depression in adults with type 1 diabetes. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Psychological interventions to improve glycaemic control in patients with type 1 diabetes: systematic review and meta-analysis of randomised controlled trials. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Depression in adolescents with diabetes. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for the treatment of depression and adherence in patients with type 1 diabetes: pilot data and feasibility. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

T1-REDEEM: A Randomized Controlled Trial to Reduce Diabetes Distress Among Adults With Type 1 Diabetes. [2022]