iACT for Type 1 Diabetes with Eating Disorders

(T1DE Trial)

Recruiting at 1 trial location

Overseen By Rhonda M Merwin, Ph.D.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Suicidal ideation, Anorexia, Substance abuse, others

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

Compensation: Varies

Number of Visits: 12

Duration: 36 weeks

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks the best way to assist people with type 1 diabetes who struggle with eating disorders. It compares two treatments: Acceptance and Commitment Therapy (ACT), which focuses on values and actions, and Supportive Diabetes Counseling, which provides guidance and goal setting. The trial evaluates whether these treatments improve blood sugar levels, ease eating disorder symptoms, and reduce diabetes-related stress. Individuals with type 1 diabetes and an eating disorder involving binge eating or problematic weight control behaviors may be suitable candidates. Participants will attend sessions and use their phones to stay engaged and track progress. As an unphased trial, this study offers a unique opportunity to explore innovative treatments and contribute to valuable research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Acceptance and Commitment Therapy (ACT) is generally safe for people with Type 1 diabetes and eating disorders. Past studies have demonstrated that ACT can improve symptoms of eating disorders and reduce diabetes-related stress, indicating it is well-tolerated by patients. Reports of serious side effects are rare. This therapy offers psychological support, which is typically safer than medical treatments.

Supportive Diabetes Counseling (SDC) also presents low safety concerns. This method involves listening support and education about diabetes care, adhering to guidelines from the American Diabetes Association. Such counseling is considered safe and is widely used in diabetes care without serious side effects.

Both treatments provide non-invasive psychological support, which usually carries a low risk of harm. It is important to consult a healthcare provider to understand any personal risks before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iACT treatment because it offers a unique approach for managing Type 1 Diabetes alongside eating disorders by utilizing Acceptance and Commitment Therapy (ACT). Unlike standard treatments that might focus solely on insulin management or nutritional counseling, iACT combines psychological flexibility and mindfulness strategies tailored specifically for the dual challenge of diabetes and eating disorders. This protocol is innovative because it incorporates a mix of in-person and virtual sessions, along with a convenient text messaging platform for support, which makes it more accessible and adaptable to real-world settings. By focusing on acceptance and commitment principles, iACT aims to improve emotional well-being and self-care behaviors, presenting a potentially more holistic and integrated treatment option.

What evidence suggests that this trial's treatments could be effective for type 1 diabetes with eating disorders?

Research has shown that Acceptance and Commitment Therapy (ACT), which participants in this trial may receive, can help treat eating disorders in people with type 1 diabetes (T1D). A small initial study found that participants improved in managing their eating issues. ACT encourages individuals to accept their thoughts and feelings and take actions aligned with their values, potentially aiding those with T1D in better managing their eating habits. In contrast, Supportive Diabetes Counseling (SDC), another treatment option in this trial, provides guidance and education to improve diabetes care, though less evidence exists regarding its specific effectiveness for eating disorders in T1D. Both treatments aim to enhance overall diabetes management and well-being. ^{1 2 3 6 7}

Who Is on the Research Team?

Rhonda Merwin, PhD

Principal Investigator

Duke University faculty

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• iACT

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.

How Is the Trial Designed?

Group I: Acceptance and Commitment Therapy for Type 1 Diabetes - Eating Disorder (ACT-T1DE) Experimental Treatment 1 Intervention

ACT-T1DE consists of 12 sessions of flexible ACT protocol tailored to the unique conditions and needs of type 1 diabetes eating disorders. The protocol is based on an initial pilot study (Merwin et al., 2021); however, the current protocol has been modified, based on key stakeholder feedback and to optimize real-world implementation. Modifications include transition from the use of a mobile app to a text messaging platform and a combination of in-person and virtual visits.

Group II: Supportive Diabetes Counseling (SDC) Active Control 1 Intervention

The SDC condition is a flexible protocol of 12 sessions consisting of supportive listening, diabetes-related psychoeducation and goal setting, based on the ADA Type 1 Diabetes Self-Care Manual and ADCES7 Self-Care Behaviors.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

The Miriam Hospital

Collaborator

Trials

252

Recruited

39,200+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7789378/

An open trial of app-assisted acceptance and commitment ... The current study was a pilot open trial of iACT, a novel intervention for EDs in T1D grounded in Acceptance and Commitment Therapy (ACT).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05540704?cond=diabetes

Study Comparing Acceptance and Commitment Therapy ... The goal of this study is to test the effectiveness of two different approaches to treating problematic eating and weight control in type 1 ...

3. breakthrought1d.org breakthrought1d.org/grants/united-states/north-carolina/a-randomized-controlled-trial-of-iact-a-novel-mhealth-intervention-for-eating-disorders-in-type-1-diabetes-mellitus/

Changing the T1DE: A randomized controlled trial ... The primary objective of this research is to test a novel treatment for EDs in T1D (iACT), optimized for delivery in routine health care setting. iACT is an ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666776224003740

Safety of a co-designed cognitive behavioural therapy ... There is no effective intervention that integrates type 1 diabetes and eating disorders treatment for those with mild to moderate presentations of T1DE in ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33407910/

An open trial of app-assisted acceptance and ... - PubMed The current study was a pilot open trial of iACT, a novel intervention for EDs in T1D grounded in Acceptance and Commitment Therapy (ACT).

6. d-nb.info d-nb.info/1226654592/34

An open trial of app-assisted acceptance and commitment ... Conventional eating disorder (ED) treatments have been largely ineffective for T1D patients, indicating the need to tailor treatments to this patient population.

7. withpower.com withpower.com/trial/phase-feeding-and-eating-disorders-2-2023-695f8

iACT for Type 1 Diabetes with Eating Disorders (T1DE 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.