Dialectical Behavioural Therapy for Type 2 Diabetes

Recruiting at 1 trial location

Overseen By Brandy Wicklow, MD MSc

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Brandy Wicklow

Disqualifiers: Type 1 diabetes, Cancer, Inflammatory illness, Psychotic disorder, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 18

Duration: 16 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop a new therapy for Indigenous youth with Type 2 Diabetes (T2D) by combining Dialectical Behavioural Therapy (DBT) with traditional medicine. The goal is to improve mental wellness, medication adherence, and control of blood sugar and kidney health. Participants will engage in weekly DBT sessions, with the option to incorporate elements of traditional medicine. The trial seeks youth aged 14-22 who have been diagnosed with Type 2 Diabetes and are interested in therapies focusing on mindfulness and personal strengths. As an unphased trial, this study offers a unique opportunity to explore innovative therapies that integrate cultural practices with modern techniques for holistic health improvement.

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 focuses on a therapy program for diabetes management, so it's best to discuss your medications with the trial coordinators.

What prior data suggests that Dialectical Behavioural Therapy is safe for Indigenous children with Type 2 Diabetes?

Research has shown that Dialectical Behavioural Therapy (DBT) is generally safe and well-tolerated. In studies with individuals who have diabetes, DBT did not cause any serious side effects and improved mental health without complicating diabetes management.

One study found that DBT led to better outcomes for individuals with borderline personality disorder, such as reducing harmful behaviors, compared to those who did not receive DBT. This suggests that DBT can be a valuable addition to treatment plans.

While DBT has shown promise in various contexts, it is important to note that this trial is in an early stage called a pilot phase. Researchers are still determining the best way to provide the therapy and integrate it with traditional medicine. This phase is crucial to ensure the treatment is safe and effective for all participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Dialectical Behavioural Therapy (DBT) for Type 2 Diabetes because it offers a novel approach compared to traditional treatments like medication and lifestyle changes that focus primarily on physical health. DBT stands out by addressing the emotional and psychological factors that can impact diabetes management, using skills training to help patients better cope with stress and emotional eating, which are common challenges for those with diabetes. Additionally, the integration of culturally tailored components developed with Indigenous communities adds a personalized and inclusive aspect to the therapy, potentially increasing its effectiveness and acceptance among diverse patient populations.

What evidence suggests that Dialectical Behavioural Therapy is effective for Type 2 Diabetes?

This trial will evaluate the effectiveness of Dialectical Behavioural Therapy (DBT) for individuals with Type 2 Diabetes. Studies have shown that DBT can improve health for people with diabetes by aiding in emotion management and leading to better blood sugar control. Specifically, one study found that patients who participated in DBT became more resilient and adaptable, which is important for handling a long-term condition like diabetes. Other findings suggest that DBT can boost mental well-being, crucial for managing diabetes overall. These results indicate that DBT could be a promising way to support people with Type 2 Diabetes, especially when used alongside traditional treatments. Participants in this trial will be randomized to receive either DBT skills training or standard medical care. ^{1 6 7 8 9}

Who Is on the Research Team?

Brandy Wicklow, MD MSc

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

This trial is for First Nations adolescents aged 14-17 with Type 2 Diabetes. It includes those interested in a program combining Dialectical Behavioural Therapy (DBT) and traditional medicine. Caregivers may also participate. Youth not within the age range or without Type 2 Diabetes are excluded.

Inclusion Criteria

Fifteen (15) youths, and one caregiver, will be randomized to receive DBT and fifteen (15) adolescents will be randomized to a control group

I am between 14 and 22 years old.

I am between 14 and 22 years old and have type 2 diabetes that started when I was young.

Exclusion Criteria

My diabetes is not type 2; it could be type 1, genetic, or due to other causes.

History of active psychotic disorder

History of past year suicide attempt or an active plan

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Treatment

Participants receive a 90-minute DBT skills training session every week for 16 weeks

16 weeks

16 visits (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including qualitative interviews

3 months

1-2 visits (virtual or in-person)

Optional Extension

Participants may opt into additional modules incorporating traditional Indigenous medicines and knowledge

Variable

What Are the Treatments Tested in This Trial?

Interventions

• Dialectical Behavioural Therapy

Trial Overview

The iCARE 2.0 study tests DBT combined with traditional medicine practices to improve mental wellness, medication adherence, glycemic control, and kidney health in Indigenous youth with T2D. Participants will be randomly assigned to receive either this intervention or be placed in a control group.

How Is the Trial Designed?

Group I: Dialectical Behavioural Therapy Experimental Treatment 1 Intervention

Participants randomized to the Dialectical Behavioural Therapy (DBT) skills training intervention will receive a 90-minute DBT skills training session every week for 16 weeks total. The sessions will be facilitated by a health practitioner supervised by a clinical health psychologist with expertise in program development and DBT-adaptations for a variety of populations. Sessions for Pilot 1 will be delivered via Zoom HealthCare and in person if allowable. In-person sessions would be delivered at the Children's Hospital Research Institute of Manitoba. Pilot 2 will be adapted to address any additional needs uncovered through he qualitative assessment of Pilot 1. Traditional medicine components will be developed within the first 2 years of the grant by Indigenous researchers, patient and parent advisors, elders, and community advisory groups. These elements will be offered as an encouraged, yet optional component (additional modules) within the 16-week DBT intervention in Pilot 2.

Group II: Control Active Control 1 Intervention

Participants randomized to the control arm will receive standard medical care and clinical follow-up. Controls will be offered DBT after completion of Pilot 1 and 2. Participation will be optional.

Dialectical Behavioural Therapy is already approved in United States, Canada, European Union for the following indications:

Approved in United States as DBT for:

• Borderline personality disorder
• Suicidal ideation
• Self-harm
• Emotional dysregulation

Approved in Canada as DBT for:

• Borderline personality disorder
• Suicidal ideation
• Self-harm
• Emotional dysregulation
• Type 2 diabetes (pilot intervention)

Approved in European Union as DBT for:

• Borderline personality disorder
• Suicidal ideation
• Self-harm
• Emotional dysregulation

Who Is Running the Clinical Trial?

Dr. Brandy Wicklow

Lead Sponsor

Trials

1

Recruited

60+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

Cognitive behavioral therapy (CBT) and mindfulness interventions have shown promise in improving mental health and glycemic control in adolescents at risk for type 2 diabetes, particularly in girls, with mindfulness leading to greater reductions in depression and insulin resistance compared to CBT.

The current data is limited and primarily focuses on adolescent girls; future research should include male adolescents and those already diagnosed with type 2 diabetes, as well as explore longer intervention durations and maintenance strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy and Mindfulness-Based Cognitive Therapy in Children and Adolescents with Type 2 Diabetes. Pinhas-Hamiel, O., Hamiel, D.[2022]

Cognitive Behaviour Therapy (CBT) interventions can improve self-management practices in individuals with type 2 diabetes, as highlighted by a rapid review of nine studies, primarily from developing countries.

The review emphasizes the importance of tailoring CBT interventions to the socio-economic contexts of individuals, particularly in South Africa, to enhance their effectiveness in managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the role of CBT in the self-management of type 2 diabetes: A rapid review. Visagie, E., Deacon, E., Kok, R.[2023]

A study involving 158 obese adults with type 2 diabetes found that a cognitive behavioural group therapy (group-CBT) program did not significantly improve long-term weight maintenance compared to usual care alone after an initial weight loss from dieting.

Both groups experienced similar weight regain after 2 years, with the group-CBT participants regaining an average of 4.0 kg and the control group regaining 4.7 kg, indicating that the additional therapy did not provide a meaningful advantage in preventing weight regain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy and weight regain after diet in type 2 diabetes: results from the randomised controlled POWER trial. Berk, KA., Buijks, HIM., Verhoeven, AJM., et al.[2020]

Cognitive-behavioral therapy (CBT) has been shown to effectively improve short-term and medium-term glycaemic control in adults with diabetes, although its long-term effects on glycaemic control remain inconclusive.

CBT significantly reduces symptoms of anxiety and depression in the short and medium term, and it also shows benefits for long-term depression, highlighting its potential as a psychological intervention for improving mental health in individuals with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive-behavioural therapy on glycaemic control and psychological outcomes in adults with diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials. Uchendu, C., Blake, H.[2018]

Cognitive behavior therapy (CBT) significantly reduces depression symptoms and improves quality of life in diabetic patients with comorbid depression, based on a meta-analysis of 10 randomized controlled trials involving 998 participants.

CBT also leads to long-term improvements in fasting glucose levels and anxiety, although it does not show significant effects on glycemic control or diabetes-related distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of randomized controlled trials of cognitive behavior therapy for patients with diabetes and depression. Li, C., Xu, D., Hu, M., et al.[2018]

Lifestyle changes, supported by standard behavioral interventions and cognitive behavioral therapies, are crucial in managing type 2 diabetes and can enhance adherence to healthy behaviors and medication regimens.

The review suggests that acceptance-based therapies (ABTs) could be a promising new approach for diabetes management, but further research is needed to confirm their effectiveness in improving glucose control and promoting lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance-based therapy: the potential to augment behavioral interventions in the treatment of type 2 diabetes. Cardel, MI., Ross, KM., Butryn, M., et al.[2022]

Cognitive Behavioral Therapy (CBT) interventions significantly improved glycaemic control in diabetes patients, reducing HbA1c levels by an average of 0.275%, based on a meta-analysis of 23 randomized controlled trials involving 2,619 participants.

CBT also effectively reduced depression symptoms in these patients, with an average reduction of 2.788 points on depression scales, indicating that tailored CBT strategies can enhance both psychological and physiological outcomes in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Cognitive Behavioral Therapy-Based Intervention on Improving Glycaemic, Psychological, and Physiological Outcomes in Adult Patients With Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials. Yang, X., Li, Z., Sun, J.[2022]

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