BEET Program + CBT for Type 2 Diabetes and Eating Disorders

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Pregnancy, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy Guided Self-Help, The BEET Diabetes Program for Type 2 Diabetes and Eating Disorders?

Research shows that cognitive behavioral therapy (CBT) is effective for treating eating disorders like bulimia and binge eating disorder. Additionally, CBT has been used to help manage diabetes and eating disorders together, showing improvements in blood sugar levels and psychological symptoms. ^{1 2 3 4 5}

Is the BEET Program + CBT safe for humans?

Cognitive Behavioral Therapy (CBT) is generally considered safe for treating eating disorders, with research showing it is effective for conditions like bulimia nervosa and binge eating disorder. However, specific safety data for the BEET Program combined with CBT for type 2 diabetes and eating disorders is not available in the provided research. ^{2 4 6 7 8}

How is the BEET Program + CBT treatment for Type 2 Diabetes and Eating Disorders different from other treatments?

The BEET Program combined with Cognitive Behavioral Therapy (CBT) Guided Self-Help is unique because it integrates a structured self-help approach with CBT, which is typically used for eating disorders, to specifically address the psychological and behavioral aspects of managing Type 2 Diabetes alongside eating disorders. This combination aims to improve both diabetes management and eating disorder symptoms, offering a more holistic approach compared to traditional treatments that may focus on one condition at a time. ^{3 4 7 9 10}

What is the purpose of this trial?

Disordered eating behaviors (DEBs, e.g., binge eating or restrictive eating) can significantly impact type 2 diabetes (T2D) self-management and engagement in treatment for diabetes. Managing DEBs is a treatment component in diabetes self-management; however, it is not often the primary focus, and trained behavioral health providers are inconsistently involved in comprehensive diabetes management. This study plans to pilot two behavior change programs for disordered eating in T2D and gather information on factors that predict successful adoption and implementation in real-world clinical settings.

Research Team

Phoutdavone Phimphasone-Brady, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for individuals with type 2 diabetes who also struggle with disordered eating behaviors like binge or restrictive eating. It's designed to help them manage these behaviors as part of their diabetes treatment.

Inclusion Criteria

I have been diagnosed with type 2 diabetes.

HbA1c ≥ 6.5

Positive disordered eating screen: Scored ≥ 2 on the study pre-screen for Disordered Eating OR ≥2 on the Diabetes Eating Problems Survey-Revised (DEPS-R) question #2 (skipping meals), #8 (binge eating), or #15 (self-induced vomiting)

Exclusion Criteria

Plans to leave the practice in the next year

Pregnancy or planning to become pregnant in the next 12 months

I have a condition like dementia that affects my thinking.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Refinement

Behavioral health providers refine the BEET Diabetes Program for implementation in real-world settings

4 weeks

Treatment

Participants receive either the BEET Diabetes Program or Cognitive Behavioral Therapy Guided Self-help over 6 sessions

6 weeks

6 sessions (3 weekly, 3 biweekly)

Follow-up

Participants are monitored for changes in diabetes distress, self-efficacy, anxiety, HbA1c, disordered eating behaviors, and depression

4 weeks

Treatment Details

Interventions

• Cognitive Behavioral Therapy Guided Self-Help
• The BEET Diabetes Program

Trial Overview The study is testing two programs: Cognitive Behavioral Therapy Guided Self-Help and The BEET Diabetes Program, to see which might better assist in managing disordered eating in those with type 2 diabetes.

Participant Groups

Group I: The BEET Diabetes Program Experimental Treatment 1 Intervention

The BEET Diabetes program consists of 6 sessions that follow a sequence: the first 3-sessions weekly and the last 3-sessions every other week. These sessions help participants learn strategies and health behavior change through a self-monitoring form. Supporters (in this study, the BHPs) guide individuals through the program, maintain motivation, and facilitate appropriate goal-setting. The BEET Diabetes Program emphasizes treating disorder eating behaviors (DEBs) in the context of diabetes (i.e., psychoeducation on DEBs in diabetes, optimal daily glucose management, benefits of physical activity, and fruit and vegetable intake).

Group II: Cognitive behavioral Therapy Guided Self-help Active Control 1 Intervention

The Cognitive Behavioral Therapy Guided Self-help consists of 6 sessions that follow a sequence: the first 3-sessions weekly and the last 3-sessions every other week. These sessions help participants learn strategies and health behavior change through a self-monitoring form. The CBTgsh program is delivered through the self-help book: "Overcoming Binge Eating" by Christopher G. Fairburn. Guided support sessions can be provided by personnel with no background training or knowledge of CBT or DEBs, as the book acts as the "expert."

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

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]

Cognitive behavioral therapy for eating disorders (CBT-ED) is shown to be more effective than other treatments for bulimia nervosa (BN) and binge eating disorder (BED), while interpersonal psychotherapy is equally effective for BED.

Current evidence does not support the effectiveness of CBT-ED for adult anorexia nervosa (AN) and is lacking for adolescents, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for the Eating Disorders. Agras, WS., Bohon, C.[2022]

A 10-session version of cognitive behavior therapy for eating disorders (CBT-T) was effective for nonunderweight cases, showing positive outcomes comparable to longer forms of CBT, despite being delivered by clinical assistants rather than specialists.

The therapy was well-received, with good retention rates and positive changes in symptoms, suggesting that CBT-T could improve access to treatment for eating disorders in various healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 10-session cognitive-behavioral therapy (CBT-T) for eating disorders: Outcomes from a case series of nonunderweight adult patients. Waller, G., Tatham, M., Turner, H., et al.[2019]

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]

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 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]

References

1. 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]

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

Cognitive Behavioral Therapy for the Eating Disorders. [2022]

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

A 10-session cognitive-behavioral therapy (CBT-T) for eating disorders: Outcomes from a case series of nonunderweight adult patients. [2019]

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

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

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. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of a novel eating disorder prevention program for young women with type 1 diabetes: A preliminary randomized trial. [2023]

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

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

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

Association of eating disorders with glycaemic control and insulin resistance in patients of type 2 diabetes mellitus. [2023]

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

An intensive DBT program for patients with multidiagnostic eating disorder presentations: a case series analysis. [2022]

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

Evidence for feasibility of implementing online brief cognitive-behavioral therapy for eating disorder pathology in the workplace. [2023]