Psychoeducation for Type 1 Diabetes

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

191 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Psychoeducation for Type 1 Diabetes?

Research shows that educational interventions, including psychoeducation, can improve outcomes for people with Type 1 diabetes by enhancing self-efficacy (confidence in managing one's own health) and quality of life, as well as reducing blood sugar levels. ^{1 2 3 4 5}

Is psychoeducation safe for humans?

Psychoeducation has been used safely in various settings, including for parents of adolescents with eating disorders and cancer survivors, without reports of harm. It is generally considered a safe component of psychological support. ^{6 7 8 9 10}

How is the psychoeducation treatment for Type 1 Diabetes different from other treatments?

Psychoeducation for Type 1 Diabetes is unique because it focuses on teaching patients about their condition and developing self-management skills, rather than using medication. This approach helps patients understand their diabetes better and manage it more effectively through education and support, which can improve their quality of life and reduce family conflict. ^{1 2 3 11 12}

What is the purpose of this trial?

In this 2-year randomized clinical trial, we will implement and assess the impact of a behavioral/psychoeducational intervention to reduce diabetes distress and improve glycemic outcomes in adolescents and young adults, aged 14-25 years, with T1D in order to optimize their short-term and long-term health.

Research Team

Lori Laffel

Principal Investigator

Joslin Diabetes Center

Korey Hood, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. England 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. [2022]

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

A comparison of two internet programs for adolescents with type 1 diabetes: design and methods. [2022]

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

Empowered to change: evidence from a qualitative exploration of a user-informed psycho-educational programme for people with type 1 diabetes. [2019]

4. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of a group psychoeducation program for the treatment of subclinical disordered eating in women with type 1 diabetes. [2015]

5. Italy pubmed.ncbi.nlm.nih.gov

Closing the gap between literature and practice: evaluation of a teaching programme (in the absence of a structured treatment) on both type 1 and type 2 diabetes. [2019]

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

Psychoeducation as an active ingredient for interventions for perinatal depression and anxiety in youth: a mixed-method systematic literature review and lived experience synthesis. [2023]

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

Implementation and evaluation of a psychoeducation program in an outpatient mental health center. [2021]

8. United States 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. [2017]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Case report: KETOLAND the psychoeducation program for ketogenic diet. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

[Psychological education as a group process for parents of adolescents with eating disorders]. [2019]

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

The effects of psychoeducation on disturbed eating attitudes and behavior in young women with type 1 diabetes mellitus. [2022]

12. Italy 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. [2022]