iACT for Type 1 Diabetes with Eating Disorders

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Rhonda Merwin, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Duke University

Disqualifiers: Suicidal ideation, Anorexia, Substance abuse, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new mobile app called iACT to help people aged 16-45 who have type 1 diabetes and binge-purge eating disorders. The app aims to improve blood sugar control and reduce eating disorder symptoms by offering support and management tools. The iACT app has been previously used to facilitate the application of ACT skills in diabetes management.

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's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment iACT for Type 1 Diabetes with Eating Disorders?

The open trial of iACT for eating disorders in type 1 diabetes showed promise by teaching acceptance and mindfulness to help manage emotional distress and improve diabetes management. Additionally, a study on multidisciplinary residential treatment for type 1 diabetes and eating disorders found significant reductions in blood glucose and psychological symptoms, suggesting that tailored interventions can be effective. ^{1 2 3 4 5}

Is iACT safe for people with type 1 diabetes and eating disorders?

The study on iACT for eating disorders in type 1 diabetes did not report any safety concerns, suggesting it is generally safe for humans. ^{1 2 6 7 8}

How is the iACT treatment different from other treatments for eating disorders in Type 1 Diabetes?

iACT is unique because it combines Acceptance and Commitment Therapy (ACT) with a mobile app to help individuals with Type 1 Diabetes manage eating disorders by teaching acceptance and mindfulness, rather than focusing on control. This approach is tailored to address the emotional distress and unique challenges faced by those with Type 1 Diabetes, unlike conventional treatments that have been largely ineffective for this group. ^{1 2 8 9 10}

Research Team

Rhonda Merwin, PhD

Principal Investigator

Duke University faculty

Eligibility Criteria

This trial is for people aged 16-50 with Type 1 Diabetes who also struggle with eating disorders like bulimia or binge eating. They must manage their diabetes independently and not have a history of substance abuse, psychosis, suicidal behavior, certain other eating disorders, or be non-English speakers.

Inclusion Criteria

You have an eating disorder that involves binge eating or unhealthy attempts to control weight, such as withholding insulin.

Independently manages diabetes (not reliant on a caregiver)

I have been diagnosed with Type 1 diabetes.

Exclusion Criteria

You have trouble noticing when your blood sugar gets too low, as determined by a specific assessment method.

NonEnglish speaking

You are currently thinking about hurting yourself or have recently hurt yourself.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either iACT or Usual Care and complete assessments at baseline and every 3 months for 9 months

36 weeks

Assessments at baseline, 12 weeks, 24 weeks, and 36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• iACT (Behavioral Intervention)

Trial Overview The study tests iACT, a mobile health intervention against usual care to see which helps better with glycemic control in Type 1 Diabetics with eating disorders. Participants will be randomly assigned to one of the two groups and monitored over nine months.

Participant Groups

Group I: iACT Experimental Intervention Experimental Treatment 1 Intervention

Group II: Usual Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

The Miriam Hospital

Collaborator

Trials

252

Recruited

39,200+

Maria Ducharme

The Miriam Hospital

Chief Executive Officer since 2021

Doctor of Nursing Practice from Massachusetts General Hospital Institute of Health Professions, MS in Nursing from University of Rhode Island, BS in Nursing from Rhode Island College

Mark A. Deitch

The Miriam Hospital

Chief Medical Officer

MD, MBA

Findings from Research

The pilot study of iACT, a novel intervention for eating disorders in individuals with type 1 diabetes, showed that it was both acceptable and feasible, leading to significant improvements in eating disorder symptoms and diabetes management among participants who completed 12 sessions.

Participants demonstrated increased psychological flexibility regarding their diabetes-related thoughts and feelings, with large effect sizes indicating substantial progress in managing their eating disorders and diabetes distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open trial of app-assisted acceptance and commitment therapy (iACT) for eating disorders in type 1 diabetes. Merwin, RM., Moskovich, AA., Babyak, M., et al.[2021]

A study involving 29 women with type 1 diabetes and eating disorders showed that multidisciplinary residential treatment significantly reduced blood glucose levels and improved symptoms of eating disorders and psychological concerns.

Longer durations of treatment were linked to greater improvements in psychological symptoms, suggesting that extended care may enhance overall treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary residential treatment of type 1 diabetes mellitus and co-occurring eating disorders. Dickens, YL., Haynos, AF., Nunnemaker, S., et al.[2021]

A new cognitive behavioral therapy-based intervention toolkit was developed collaboratively by 15 individuals with type 1 diabetes and disordered eating, along with 25 healthcare professionals, ensuring it meets the specific needs of patients.

The intervention, which focuses on improving diabetes self-care, will be delivered over 12 sessions by a trained diabetes specialist nurse and is set to be tested in a feasibility randomized controlled trial, highlighting its potential for tailored treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a novel intervention for type 1 diabetes and disordered eating using a participatory action design process: Safe management of people with Type 1 diabetes and EAting Disorders studY (STEADY). Zaremba, N., Robert, G., Allan, J., et al.[2022]

Women with insulin-dependent diabetes who have eating disorders experience higher rates of diabetic complications and engage in insulin manipulation, highlighting the serious health risks associated with these disorders.

While the Eating Attitudes Test (EAT) alone is not very effective for screening eating disorders, a high EAT score combined with insulin manipulation can reliably identify nearly all cases of eating disorders in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for eating disorders in diabetes mellitus. Cantwell, R., Steel, JM.[2019]

This study developed a cognitive behavioural therapy model that outlines how disordered eating can develop and persist in individuals with type 1 diabetes, based on interviews with 23 women, including those with and without disordered eating.

Key resilience factors identified include 'good enough' psychological adaptation, integrating diabetes into one's identity, and practicing self-care, which can help protect against the development of disordered eating in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cognitive behavioural model of the bidirectional relationship between disordered eating and diabetes self care in people with type 1 diabetes mellitus. Harrison, A., Zaremba, N., Brown, J., et al.[2022]

In a study of 87 adolescents with type 1 diabetes, those with disordered eating behavior (DEB) showed a significant increase in HbA1c levels over three years, indicating poorer metabolic control compared to those without DEB.

The findings suggest that DEB in adolescents with type 1 diabetes is associated with a worsening prognosis for metabolic control, highlighting the need for targeted interventions in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Three-year follow up of metabolic control in adolescents with type 1 diabetes with and without eating disorders]. Figueroa Sobrero, A., Evangelista, P., Mazza, C., et al.[2022]

In a study of 100 women with type 1 diabetes who were assessed for eating disorders, most showed improvement in their symptoms after treatment at a specialized day hospital, but only 18.8% achieved a good immediate treatment outcome.

The treatment outcomes for women with type 1 diabetes were significantly poorer compared to those without diabetes, highlighting the need for further research to understand and improve treatment strategies for this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eating disorders in individuals with type 1 diabetes: case series and day hospital treatment outcome. Colton, PA., Olmsted, MP., Wong, H., et al.[2022]

Individuals with both Type 1 Diabetes Mellitus (T1DM) and eating disorders (ED) experienced higher dropout rates and worse treatment outcomes compared to those with ED alone, despite similar levels of eating disorder psychopathology.

The study highlights the importance of addressing personality traits and insulin misuse in T1DM patients when designing treatment interventions for eating disorders, suggesting that these factors significantly impact motivation and treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment outcome of patients with comorbid type 1 diabetes and eating disorders. Custal, N., Arcelus, J., Agüera, Z., et al.[2022]

Eating disorders are increasingly common among individuals with Type 1 diabetes, with standard treatments often yielding poor clinical outcomes, highlighting the need for tailored interventions.

A theoretical maintenance model for disordered eating in this population has been developed, emphasizing the role of insulin mismanagement and emotional responses from others, which could inform future experimental studies and treatment technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a theoretical maintenance model for disordered eating in Type 1 diabetes. Treasure, J., Kan, C., Stephenson, L., et al.[2016]

A study involving 10 Australasian pediatric clinics found that most do not use specific screening tools for disordered eating in children with Type 1 Diabetes, relying instead on routine clinical interviews.

Despite some clinics reporting disordered eating rates over 20%, the lack of screening tools and barriers like time constraints and staff confidence may lead to underdiagnosis, missing chances for early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening Practices for Disordered Eating in Paediatric Type 1 Diabetes Clinics. Hanley Burden, E., Hart, M., Pursey, K., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

An open trial of app-assisted acceptance and commitment therapy (iACT) for eating disorders in type 1 diabetes. [2021]

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

Multidisciplinary residential treatment of type 1 diabetes mellitus and co-occurring eating disorders. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Developing a novel intervention for type 1 diabetes and disordered eating using a participatory action design process: Safe management of people with Type 1 diabetes and EAting Disorders studY (STEADY). [2022]

4. England pubmed.ncbi.nlm.nih.gov

Screening for eating disorders in diabetes mellitus. [2019]

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

A cognitive behavioural model of the bidirectional relationship between disordered eating and diabetes self care in people with type 1 diabetes mellitus. [2022]

6. Argentina pubmed.ncbi.nlm.nih.gov

[Three-year follow up of metabolic control in adolescents with type 1 diabetes with and without eating disorders]. [2022]

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

Eating disorders in individuals with type 1 diabetes: case series and day hospital treatment outcome. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Treatment outcome of patients with comorbid type 1 diabetes and eating disorders. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Developing a theoretical maintenance model for disordered eating in Type 1 diabetes. [2016]

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

Screening Practices for Disordered Eating in Paediatric Type 1 Diabetes Clinics. [2021]