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

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

What data supports the effectiveness of the treatment Dialectical Behavioural Therapy for Type 2 Diabetes?

While there is no direct evidence for Dialectical Behavioural Therapy (DBT) in treating type 2 diabetes, similar therapies like Cognitive Behavioral Therapy (CBT) have been shown to help improve psychological outcomes and glycemic control in people with diabetes. This suggests that DBT, which shares some principles with CBT, might also be beneficial. ^{1 2 3 4 5}

How is Dialectical Behavioural Therapy different from other treatments for type 2 diabetes?

Dialectical Behavioural Therapy (DBT) is unique for type 2 diabetes as it focuses on emotional regulation and mindfulness, which can help patients manage stress and emotional eating, unlike traditional treatments that primarily focus on diet and medication. ^{2 4 5 6 7}

What is the purpose of this trial?

In partnership with youth, parents, and community members the investigators have co-developed a program of research designed to address the substantial health disparities faced by First Nations children and families, and the calls to action from the Truth and Reconciliation Report. Specifically; the investigators aim to address the high rates of kidney disease in Indigenous children living with Type 2 Diabetes (T2D), by identifying and understanding the root causes for progression of kidney disease and working together to build an evidenced based, novel therapy for diabetes that focuses on mindfulness, personal strengths and incorporates traditional medicine practices that are meaningful to patients. The investigators have planned 2 pilots in order to address the uncertainties surrounding the planning of a larger definitive trial and allow adequate engagement and building of a meaningful traditional medicine component. These pilots will inform the development of a co-designed, feasible, and embraced Dialectical Behavioural Therapy (DBT) skills training and traditional teachings intervention, which is adequately powered to examine effectiveness on outcomes such as mental wellness, medication adherence, and improved glycemic control and renal function. Research Aims: 1. Determine the recruitment, enrollment and adherence rates to the intervention. 2. Evaluate acceptability of the intervention using traditional qualitative methods and Indigenous world view methodology 3. Determine the estimated effect size required to power a large-scale DBT randomized control trial for the outcomes quality of life (primary), glycemic control and albuminuria (secondary). Study Hypotheses: 1. The investigators hypothesize that a DBT intervention will be feasible on a local and National Platform and will be acceptable and embraced by youth with T2D as an important component of their management plan. 2. The investigators hypothesize that the additional of traditional medicine elements will increase the acceptability and adherence to DBT for Indigenous children.

Research Team

Brandy Wicklow, MD MSc

Principal Investigator

University of Manitoba

Eligibility Criteria

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

I have a chronic illness like rheumatoid arthritis or Crohn's disease.

I have had cancer in the past.

Currently pregnant (eligible at 3 months post-partum)

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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 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]

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]

References

1. England 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. [2018]

2. Germany 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. [2020]

3. Switzerland 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. [2022]

4. England 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. [2018]

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

Cognitive Behavioral Therapy and Mindfulness-Based Cognitive Therapy in Children and Adolescents with Type 2 Diabetes. [2022]

6. South Africa pubmed.ncbi.nlm.nih.gov

Exploring the role of CBT in the self-management of type 2 diabetes: A rapid review. [2023]

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

Acceptance-based therapy: the potential to augment behavioral interventions in the treatment of type 2 diabetes. [2022]