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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a single-session depression intervention (T1D-specific depression SSI) can improve mood and health outcomes for young people with type 1 diabetes. Researchers seek to assess the ease of recruiting participants and the perceived helpfulness of the session. Participants will either engage in this intervention or receive educational materials about diabetes. The trial is suitable for individuals aged 11-18 who have had type 1 diabetes for at least six months, have recently shown signs of depression, and are not currently receiving mental health treatment. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance mental health support for young people with type 1 diabetes.

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.

What prior data suggests that this single-session intervention is safe for youth with type 1 diabetes?

Research has shown that single-session programs for young people with type 1 diabetes are generally easy to manage. These programs aim to make therapy more accessible and improve mood with few side effects. Studies on similar programs have not found any major negative effects, indicating safety for participants.

This trial does not involve medication but focuses on teaching and planning personal activities, so it is considered low-risk. The teaching component includes learning about depression and how actions can affect feelings and thoughts. Participants also identify important areas of their life, such as family or hobbies, that bring them joy. This approach is designed to be supportive and helpful, with little chance of causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the T1D-specific depression Single Session Intervention (SSI) because it offers a novel, quick approach to tackling depression in youth with Type 1 Diabetes (T1D). Unlike traditional ongoing therapies or medication-based treatments, this intervention is unique as it delivers psychoeducation and personalized activity planning in just one session. It focuses on empowering young individuals by helping them identify meaningful areas in their lives and creating actionable steps to improve their mental health. This streamlined, targeted method could provide quicker relief and enhance the quality of life for those managing both T1D and depression.

What evidence suggests that this single-session depression intervention could be effective for youth with type 1 diabetes?

Research has shown that single-session interventions (SSIs) can effectively reduce depression in young people with type 1 diabetes (T1D). In this trial, participants will receive either the T1D-specific depression SSI or T1D Education as a placebo comparator. The T1D-specific depression SSI involves learning about depression, understanding personal values, and planning activities to improve mood. One study found that SSIs made it easier for young people to seek help and improved their mental health. Another study reported that short, personalized sessions for teens with T1D and depression improved both mood and health. These findings suggest that a single, focused session could be a practical way to assist young people with T1D who are dealing with depression. ^{1 2 3 4 5}

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

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06752369

Adapting Single Sessions Interventions for Type 1 Diabetes The T1D-specific depression SSI will include 1) psychoeducation about depression, including how behavior shapes feelings and thoughts, 2) a values assessment, ...

2. reporter.nih.gov reporter.nih.gov/project-details/11052617

Integrated Pediatric Care to Reduce Depression and HbA1c Targeted single-session interventions (SSIs) may alleviate barriers to accessing traditional outpatient therapy and reduce depressive symptoms in youth with T1D ...

3. withpower.com withpower.com/trial/single-session-intervention-for-type-1-diabetes-a6db1

Single Session Intervention for Type 1 Diabetes ... 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 ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06752369/adapting-single-sessions-interventions-for-type-1-diabetes

Adapting Single Sessions Interventions for Type 1 Diabetes The goal of this clinical trial is to learn if implementing a single-session depression intervention for youth with type 1 diabetes (T1D) is ...

5. diabetes.jmir.org diabetes.jmir.org/2024/1/e55165/

Moderating Effect of Depression on Glycemic Control in an ... A brief, culturally tailored eHealth parenting intervention improved health outcomes among Black adolescents with T1D and depressive symptoms.