Telemedicine-Delivered Cognitive Behavioral Therapy + CGM for Type 1 Diabetes & Mental Health

(UP-CBT Trial)

Recruiting at 1 trial location

Overseen By Shivani Agarwal, MD/MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein College of Medicine

Must not be taking: Psychotropics

Disqualifiers: Pregnancy, Bipolar, Psychotic, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

94 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if using mental health support along with a blood sugar monitoring device helps adults with type 1 diabetes manage their condition better. The study focuses on those who struggle with both mental health and blood sugar control.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but you must be on a stable dose of any psychotropic medication for at least 6 weeks before joining.

Is the Unified Protocol for Cognitive Behavioral Therapy safe for humans?

The Unified Protocol (UP) for Cognitive Behavioral Therapy has been studied for treating emotional disorders and is generally considered safe for humans, with studies showing improvements in mental health conditions like depression and anxiety. ^{1 2 3 4 5}

How is the treatment Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) unique for type 1 diabetes and mental health?

The Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) is unique because it is a flexible therapy that can be delivered via telemedicine and targets a wide range of emotional disorders, making it adaptable for individuals with type 1 diabetes who may also experience mental health challenges. This approach combines cognitive behavioral therapy with continuous glucose monitoring (CGM) to address both psychological and diabetes management needs. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment Telemedicine-Delivered Cognitive Behavioral Therapy + CGM for Type 1 Diabetes & Mental Health?

Research shows that the Unified Protocol (UP), a flexible form of cognitive behavioral therapy, is effective for treating various emotional disorders, including anxiety and mood disorders, when delivered virtually. This suggests that UP could be beneficial for mental health in people with Type 1 Diabetes when combined with continuous glucose monitoring. ^{1 2 3 4 5}

Who Is on the Research Team?

Jeffrey Gonzalez, PhD

Principal Investigator

Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking young adults aged 18-35 with Type 1 diabetes and HbA1c levels between 7.5% and 14%. Participants must have had diabetes for at least six months and be diagnosed with anxiety or depression. It's not open to those with certain disabilities, pregnant women, recent users of psychotropic medications without a stable dose, or individuals who've recently used CBT.

Inclusion Criteria

I have had Type 1 diabetes for at least 6 months.

I have been diagnosed with anxiety or depression.

Your HbA1c levels are between 7.5% and 14%.

Exclusion Criteria

I have been on the same dose of my mental health medication for at least 6 weeks.

I am not on medications or have had procedures that affect my blood sugar levels or use of a CGM.

You have been diagnosed with severe mental health conditions like bipolar disorder, psychotic disorder, severe eating disorder, or substance abuse disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) with Continuous Glucose Monitoring (CGM) or CGM only for the first 6 months

6 months

Virtual visits for therapy sessions and CGM data review

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of anxiety, depression, and glycemic control

6 months

Virtual assessments

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitoring (CGM)
• Unified Protocol for Cognitive Behavioral Therapy (UP-CBT)

Trial Overview The study tests telemedicine-delivered UP-CBT combined with continuous glucose monitoring (CGM) to improve mental health symptoms and blood sugar control in young adults with Type 1 diabetes. The therapy aims to help manage anxiety and depression while monitoring glucose levels.

How Is the Trial Designed?

Group I: Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) with Continuous Glucose Monitoring Experimental Treatment 2 Interventions

Participants randomized to this arm will receive the Unified Protocol for Cognitive Behavioral Therapy (UP-CBT), enhanced by review of Continuous Glucose Monitoring (CGM) data. Participants will wear study-supplied CGM for the first 6 months of their participation in the trial.

Group II: Continuous Glucose Monitoring (CGM) Only Active Control 1 Intervention

Participants randomized to receive Continuous Glucose Monitoring (CGM) will continue to receive their usual care and will also wear CGM throughout the first 6 months of their participation in the trial.

Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) is already approved in United States, European Union for the following indications:

Approved in United States as Unified Protocol for:

• Anxiety disorders
• Depressive disorders
• Obsessive-compulsive disorder
• Posttraumatic stress disorder
• Borderline personality disorder

Approved in European Union as Unified Protocol for:

• Anxiety disorders
• Depressive disorders
• Obsessive-compulsive disorder
• Posttraumatic stress disorder

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+

DexCom, Inc.

Industry Sponsor

Trials

151

Recruited

35,700+

Kevin Sayer

DexCom, Inc.

Chief Executive Officer since 2015

Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Published Research Related to This Trial

A brief online version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders was tested with 19 young adults, showing that 72% attended at least four out of five sessions, indicating good feasibility for this format.

Participants reported that key concepts from the therapy, like understanding emotions and mindfulness, were useful in their daily lives, and there was a significant reduction in anxiety-related life impairment at the 12-week follow-up compared to baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a brief, online transdiagnostic psychotherapy for young adults. Dimitropoulos, G., Lindenbach, D., Rowbotham, M., et al.[2023]

The Unified Protocol (UP) for treating emotional disorders has shown promising results in a virtual group format, with significant improvements in depression, emotional regulation, and quality of life in a previous pilot study of 7 subjects.

After three months, the positive effects of the UP were maintained, indicating its potential for long-term efficacy in teletherapy settings, although more extensive research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unified Protocol for the transdiagnostic treatment of emotional disorders in virtual and group format in Argentina: three months follow-up of a pilot study Celleri, M., Cremades, CF., Rojas, L., et al.[2023]

The Unified Protocol (UP) is an emotion-focused cognitive-behavioral treatment that is being tested in an ongoing randomized controlled trial, showcasing its potential as a transdiagnostic approach for various emotional disorders.

The case example demonstrates how the UP's modular structure allows for tailored treatment, applying specific principles to address the individual needs of the patient, which may enhance its effectiveness across different diagnoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders: A Case Study. Boisseau, CL., Farchione, TJ., Fairholme, CP., et al.[2022]

The Unified Protocol (UP) for treating emotional disorders was tested on five patients with panic disorder over a 3-week baseline and eight treatment sessions, showing significant reductions in panic severity and overall anxiety after treatment.

Improvements in anxiety symptoms were maintained during a 4-week follow-up, suggesting that UP is an effective and culturally adaptable intervention for anxiety disorders in low- and middle-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary examination of unified protocol for transdiagnostic treatment of emotional disorders in patients with panic disorder: a single-case experimental design in Iran. Zemestani, M., Davoudi, F., Farhadi, A., et al.[2022]

The Unified Protocol (UP) for treating emotional disorders was found to be as effective as established single disorder protocols (SDPs) in reducing symptoms of co-occurring emotional disorders among 179 adults, with significant improvements observed from baseline to post-treatment and at 12-month follow-up.

Both treatment approaches led to large reductions in symptoms of generalized anxiety, social anxiety, and depression, indicating that the UP is a viable and potentially more cost-effective option for treating multiple emotional disorders simultaneously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Unified Protocol for transdiagnostic treatment of comorbid psychopathology accompanying emotional disorders compared to treatments targeting single disorders. Steele, SJ., Farchione, TJ., Cassiello-Robbins, C., et al.[2019]

The study demonstrated that diabetes-focused cognitive-behavioral therapy (CBT) delivered via an online messaging system is feasible, with 11.1% of screened patients participating and showing significant engagement, as 41% completed all sessions.

Participants experienced a meaningful reduction in HbA1c levels after 12 months, with an average decrease of 6.2 mmol/mol, indicating improved glycemic control, alongside improvements in depression and anxiety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility study of real-time online text-based CBT to support self-management for people with type 1 diabetes: the Diabetes On-line Therapy (DOT) Study. Doherty, AM., Herrmann-Werner, A., Rowe, A., et al.[2022]

A study involving 200 youths with type 1 diabetes showed that using the GlucoWatch G2 Biographer (CGM) for 6 months did not lead to significant psychological benefits or adverse effects, indicating a neutral impact on mental health.

The research highlighted that youths whose parents reported better treatment adherence and diabetes-related quality of life were more likely to use the CGM frequently, suggesting that certain family characteristics may influence the effectiveness of CGM use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological aspects of continuous glucose monitoring in pediatric type 1 diabetes. , .[2022]

Multisystemic therapy (MST) significantly reduced diabetes-related stress in 127 adolescents with poorly controlled type 1 diabetes over a 6-month treatment period, indicating its effectiveness as a psychological intervention.

The improvement in metabolic control was linked to increased adherence to diabetes management rather than stress reduction, suggesting that MST enhances treatment compliance as a key mechanism for better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of multisystemic therapy on diabetes stress among adolescents with chronically poorly controlled type 1 diabetes: findings from a randomized, controlled trial. Ellis, DA., Frey, MA., Naar-King, S., et al.[2022]

Citations

1. Canada pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a brief, online transdiagnostic psychotherapy for young adults. [2023]

2. Argentina pubmed.ncbi.nlm.nih.gov

Unified Protocol for the transdiagnostic treatment of emotional disorders in virtual and group format in Argentina: three months follow-up of a pilot study [2023]

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

The Development of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders: A Case Study. [2022]

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

A preliminary examination of unified protocol for transdiagnostic treatment of emotional disorders in patients with panic disorder: a single-case experimental design in Iran. [2022]

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

Efficacy of the Unified Protocol for transdiagnostic treatment of comorbid psychopathology accompanying emotional disorders compared to treatments targeting single disorders. [2019]

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

Feasibility study of real-time online text-based CBT to support self-management for people with type 1 diabetes: the Diabetes On-line Therapy (DOT) Study. [2022]

7. Denmark pubmed.ncbi.nlm.nih.gov

Psychological aspects of continuous glucose monitoring in pediatric type 1 diabetes. [2022]

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

The effects of multisystemic therapy on diabetes stress among adolescents with chronically poorly controlled type 1 diabetes: findings from a randomized, controlled trial. [2022]