Psychoeducation for Type 1 Diabetes

Not currently recruiting at 1 trial location

Overseen By Lori M Laffel, MD, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Joslin Diabetes Center

Disqualifiers: Autism, Pregnancy, Recent study, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 26

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a psychoeducational approach, also known as psychoeducational therapy or educational therapy, to help young people with Type 1 diabetes manage their condition more effectively. The approach aims to reduce diabetes-related distress and improve blood sugar levels. Participants will be divided into two groups: one will receive the intervention in the first year, and the other in the second year. Suitable candidates for this trial are individuals aged 14-25 who have had Type 1 diabetes for at least a year and have regular internet access. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance diabetes management for many.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this psychoeducational intervention is safe for adolescents and young adults with Type 1 Diabetes?

Research has shown that psychoeducation is generally safe for people with Type 1 diabetes. Studies have found that it can improve blood sugar levels and quality of life in the short term without causing harm. No strong evidence of negative effects from psychoeducation exists, indicating it is well-tolerated across different age groups, including teenagers. While effectiveness can vary, safety concerns remain minimal. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores psychoeducation as a way to manage Type 1 Diabetes. Unlike traditional treatments that focus on insulin therapy and glucose monitoring, psychoeducation aims to empower patients with knowledge and coping strategies to better handle their condition. This approach could enhance self-management and potentially improve patients' quality of life by addressing the psychological and educational aspects of living with diabetes.

What evidence suggests that psychoeducation might be an effective treatment for Type 1 Diabetes?

Studies have shown that psychoeducation, which involves learning more about managing Type 1 Diabetes, can lead to small improvements. One study found a slight drop in HbA1c levels, important for monitoring blood sugar control. This suggests psychoeducation might help stabilize blood sugar levels. Another study noted an improvement in quality of life, which is crucial for overall well-being. However, the effects on blood sugar management are typically small and not always significant. Overall, psychoeducation may offer some benefits, but results can vary.

In this trial, participants in the Intervention Group will receive monthly psychoeducation sessions during the first year. The Control Group will receive these sessions in the second year, after the assessment of primary outcomes at one year. ^{2 4 6 7 8}

Who Is on the Research Team?

Lori Laffel

Principal Investigator

Joslin Diabetes Center

Korey Hood, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

The HAPPY T1D trial is for young people aged 14-25 with Type 1 Diabetes, who have an A1c level between 7-13%, and can use a smartphone or computer with wifi. They must speak English well enough to understand the material (5th grade level) and have had diabetes for at least a year. It's not for those pregnant or planning pregnancy, in another study recently, or with conditions like autism that could limit participation.

Inclusion Criteria

I have had Type 1 diabetes for at least a year.

I have been diagnosed with type 1 diabetes.

Your A1c level is between 7% and 13%.

Exclusion Criteria

Participation in another intervention study within the last 3 months

Currently pregnant or intending to become pregnant during the study (assessed by self-report)

Physical or mental health condition that in the determination of the investigators may limit the ability to fully participate in the study (e.g., autism)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Phase 1

Intervention group receives monthly sessions focusing on glycemic outcomes and diabetes distress

12 months

12 visits (in-person or remote)

Intervention Phase 2

Control group receives monthly sessions focusing on glycemic outcomes and diabetes distress

12 months

12 visits (in-person or remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

2 visits (in-person or remote)

What Are the Treatments Tested in This Trial?

Interventions

• Psychoeducation

Trial Overview

This trial tests a behavioral/psychoeducational program designed to help reduce stress related to diabetes (diabetes distress) and improve blood sugar control in adolescents and young adults with Type 1 Diabetes over two years.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

The Intervention Group will receive the monthly intervention sessions during the first year of the study.

Group II: Control Group Active Control 1 Intervention

The Control Group will receive the monthly intervention sessions during the second year of the study (after assessment of primary outcomes at 1 year).

Who Is Running the Clinical Trial?

Joslin Diabetes Center

Lead Sponsor

Trials

98

Recruited

26,500+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The FOCUS Program, adapted for delivery by social workers at a Cancer Support Community, significantly improved quality of life and self-efficacy for 34 cancer survivor-caregiver dyads, showing effectiveness similar to previous clinical trials.

Despite challenges in recruiting participants (60% enrollment), the program maintained high retention (92%) and fidelity (94%), indicating that it can be feasibly implemented in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Psychoeducational Program for Cancer Survivors and Family Caregivers at a Cancer Support Community Affiliate: A Pilot Effectiveness Study. Dockham, B., Schafenacker, A., Yoon, H., et al.[2017]

A brief 2.5-day psycho-educational intervention for people with Type 1 diabetes did not significantly change HbA1c levels or the incidence of severe hypoglycaemia over 12 months, indicating limited efficacy in these primary outcomes.

However, the intervention did lead to improved treatment satisfaction and patient empowerment, as evidenced by significant improvements in related psychometric measures at 3, 6, and 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effectiveness of a brief educational intervention in Type 1 diabetes: results from the BITES (Brief Intervention in Type 1 diabetes, Education for Self-efficacy) trial. George, JT., Valdovinos, AP., Russell, I., et al.[2022]

The Pediatric Education for Type 1 Diabetes (T1D) project, involving 24 children aged 6 to 16 over 12 months, effectively improved knowledge, self-management skills, and overall wellbeing in young patients with Type 1 diabetes.

The study highlights the importance of a multidisciplinary approach, including collaboration between pediatric and adult diabetologists, to enhance the quality of care and support during the transition from childhood to adulthood in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A structured therapeutic education program for children and adolescents with type 1 diabetes: an analysis of the efficacy of the "Pediatric Education for Diabetes" project. Mauri, A., Schmidt, S., Sosero, V., et al.[2022]

Citations

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Effectiveness of Educational and Psychoeducational Self ...

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Primary outcomes were HbA1c and quality of life (QOL). Secondary outcomes included coping, self-efficacy, social competence, self-management, ...

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The effectiveness of psychoeducational interventions in children and adolescents with type 1 diabetes is unclear.

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The AdDIT study in adolescents with type 1 diabetes demonstrated the safety of ACE inhibitor treatment, but the treatment did not change the ...

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Safe management of people with Type 1 diabetes ... The effects of psychoeducation on disturbed eating attitudes and behavior in young women with type 1 diabetes ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2451865425000870

Statistical analysis plan for the 24-week randomised trial of ...

This statistical analysis plan provides the framework to assess the primary, secondary, and safety outcomes of the trial.