Promoting Resilience in Stress Management (PRISM) for Diabetes Mellitus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Seattle Children's Hospital, Seattle, WA
Diabetes Mellitus+2 More
Promoting Resilience in Stress Management (PRISM) - Behavioral
Eligibility
< 65
All Sexes
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Study Summary

This study is evaluating whether a novel intervention may help improve outcomes for adolescents with type 1 diabetes.

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Eligible Conditions

  • Diabetes Mellitus
  • Type 1 Diabetes Mellitus

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Promoting Resilience in Stress Management (PRISM) will improve 2 primary outcomes and 3 secondary outcomes in patients with Diabetes Mellitus. Measurement will happen over the course of 6 months.

6 months
A1C
Diabetes-specific Quality of Life
Resilience
adherence
diabetes distress

Trial Safety

Trial Design

2 Treatment Groups

Usual Care
1 of 2
PRISM Intervention Arm
1 of 2
Active Control
Experimental Treatment

This trial requires 180 total participants across 2 different treatment groups

This trial involves 2 different treatments. Promoting Resilience In Stress Management (PRISM) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

PRISM Intervention Arm
Behavioral
The goal of the intervention is to teach resilience resource skills for use in current or future stressful situations. The total intervention consists of two, 45-60 minute, one-on-one sessions approximately 2-4 weeks apart followed by a family meeting discussing the skills learned. Following the family session through week 12, participants receive bi-weekly "booster" contacts (1:1 check-in sessions with the interventionist) to practice/refresh skills and check-ins on how skills have been utilized. These boosters will then be delivered monthly in months 4-6. In addition, all PRISM participants have access to the digital PRISM app, which offers an interactive practice and tracking interface to continue enhancing skills.
Usual CareFamilies in both randomization arms will receive usual medical care for diabetes, including psychosocial care provided by the mental health professionals affiliated with the diabetes clinic if needed. At both sites, every diabetes patient is cared for by a team of diabetes specialists which includes a provider (MD, Physician Assistant and/or Nurse Practitioner), dietician, and social worker. Subspecialty referrals for additional mental health or other support are made at the discretion of the primary diabetes provider.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Who is running the study

Principal Investigator
J. Y.
Joyce Yi-Frazier, Senior Clinical Research Scientist
Seattle Children's Hospital

Closest Location

Seattle Children's Hospital - Seattle, WA

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
• They are 13-18 years old
Diagnosed with T1D >12 months
Elevated distress score (PAID-T>=30)*****
Speak English fluently
Cognitively able to participate in intervention sessions and complete written surveys.

Patient Q&A Section

What is diabetes, autoimmune?

"Diabetes is a chronic disease that can cause significant problems. Approximately one percent of all adolescents were diagnosed with diabetes. Complications include diabetic ketoacidosis, hyperglycaemia, diabetic coma and long term complications such as eye, kidney and cardiovascular complications. The causes of diabetes may vary. Diabetes often has an autoimmune origin. Diabetes can be categorized as type 1 or type 2 based on autoimmune origins and the causes of diabetes. Type 1 diabetes results from abnormal autoimmune response against insulin, a hormone normally used to regulate blood sugar in the body. Type 2 diabetes results from the blood glucose remaining at high levels due to insulin resistance due to fatty substances in the body. Diabetes is more likely to occur in the obese." - Anonymous Online Contributor

Unverified Answer

What are the signs of diabetes, autoimmune?

"Diabetes and diabetes-related complications can present with a variety of symptoms, including unexplained weight loss, increased thirst and urination, blurry vision or loss of taste, frequent urination or no sensation to the feet, and brittle or crusted skin or rash. Diabetes may also present with fatigue or abnormal heart rhythms. It is not uncommon for diabetic patients to be asymptomatic by themselves, but to be found to have concurrent medical problems in the more advanced stages of disease.\n\nSigns of cancer are not limited to tumors on the skin, but include a wide range of signs and symptoms that are typically related to the type of cancer (e.g." - Anonymous Online Contributor

Unverified Answer

What are common treatments for diabetes, autoimmune?

"The most common treatment is insulin, with or without oral medications. The treatment of diabetes is highly individualized based on the degree of diabetic control and the presence of comorbidities including atherogenic dyslipidemia; additionally, treatment is often tailored based on the medical priorities of the patient, as well as the general health of the patient. Oral medication is commonly prescribed in addition to insulin. There are also a wide variety of other common treatments including antihypertensives, anticoagulants and glucose-lowering agents." - Anonymous Online Contributor

Unverified Answer

What causes diabetes, autoimmune?

"Autoimmunity seems to be the most important risk factor for both diabetes and autoimmune disorders in this study, and some diabetes cases were in a family with or without autoimmune disorders, while also some autoimmune cases were in a family without diabetes. It was more complicated for metabolic syndrome and/or overweight, where families without one or two of the risk factors or with both were also included. These cases did not have the family history for autoimmune or diabetes. Insulin resistance seems to be involved in the development of diabetes and autoimmune disorders, and this is due to a large number of single-nucleotide polymorphisms (SNPs) influencing insulin resistance and secretion." - Anonymous Online Contributor

Unverified Answer

How many people get diabetes, autoimmune a year in the United States?

"The most current estimates of diabetes prevalence in the United States are from the US Census Bureau's 1993-1994 American Community Surveys. That study estimated a prevalence of 8.7% – 13.4% (depending on time period), assuming a population of 55 million. This implies that approximately 675,000 U.S. residents are diagnosed with diabetes a year. This estimate is consistent with the prevalence of diabetes in the US as ascertained by data collection from more recent, large and nationally representative surveys. These new reports suggest that the average age of diagnosis with diabetes in the US continues to rise and may exceed the 75th mark some time by the end of the century." - Anonymous Online Contributor

Unverified Answer

Can diabetes, autoimmune be cured?

"T1D can certainly be managed to improve its control and may be cured. This approach can be achieved in 1/2 patients through use of injections of auto-antibodies, anti-GM1 and anti-CD20, and in 1/2 of the patients with TID use of anti-GM1 only. T2-D can be better controlled with use of anti-TNFs, anti-IGF and more rarely, anti-insulin. T1D can be managed by an oral anti-GM1, with use of anti-CD20 and, more rarely, anti-CD20, anti-CD154 and/or anti-CD19 antibodies with the improvement of its control." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets diabetes, autoimmune?

"Diabetes and its associated autoimmune disorders are more prevalent in women when compared to men. The mean age people suffer from autoimmune diabetes ranged between 23 and 42 for men, and 36 for women among the studies reviewed, with the greatest prevalence in the 50 to 60+ age range for both men and women.\n" - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving promoting resilience in stress management (prism)?

"There are several reasons why the studies cited in the table above and the ones suggested for practice are not suitable to be used as a basis for practice. Firstly, they are limited by sample size, which is insufficient or too small. Secondly, they lack an adequate methodology to investigate resilience with sufficient precision and certainty. Thirdly, they were not conducted in a clinical setting and the results may not be applicable for use in routine practice. Thus, we suggest to exclude them and we consider the studies that were already used as a basis for practice as sufficient for use in practice." - Anonymous Online Contributor

Unverified Answer

What is promoting resilience in stress management (prism)?

"Stress is associated with increased production of certain pro-inflammatory hormones. Diabetes affects this stress-hormone pattern through a number of mechanisms, which include impaired insulin signaling, oxidative stress, and reduced tissue integrity. Diabetes is associated with an increased risk of a variety of chronic diseases, all of which are associated with distress. We propose that stress can serve as a protective mechanism against both physical and mental health problems in people with diabetes through reduced release of stress hormones." - Anonymous Online Contributor

Unverified Answer

What is the latest research for diabetes, autoimmune?

"A systematic review of current literature identified several potentially interesting studies; however, the body of evidence did not provide sufficient evidence for the conclusions that could be drawn. Further research into a wide range of topics is indicated to improve the quality of the evidence." - Anonymous Online Contributor

Unverified Answer

Has promoting resilience in stress management (prism) proven to be more effective than a placebo?

"In a recent study, findings provides preliminary evidence that facilitating resilience in stress management by providing tailored resilience training may improve stress management and may be more effective than offering general supportive counselling." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for diabetes, autoimmune?

"Clinical trials are worthwhile to study the effects of the medications currently available for all of the three autoantibodies on life expectancy. They should also be conducted for those who are diagnosed before age 35, because, by this age, diabetes has already progressed to where it is associated with severe diabetic complications and increased mortality, which underscores the importance of preventive programs." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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