Dialectical Behavioural Therapy for Type 2 Diabetes
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Dr. Brandy Wicklow
Disqualifiers: Type 1 diabetes, Cancer, Inflammatory illness, Psychotic disorder, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
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.
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.
12345How 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.
24567Eligibility 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)
+6 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Dialectical Behavioural TherapyExperimental Treatment1 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: ControlActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Clinic Y, Health Sciences CentreWinnipeg, Canada
Diabetes Education Resource Centre for Adolescents Clinic, Health Sciences CentreWinnipeg, Canada
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Who Is Running the Clinical Trial?
Dr. Brandy WicklowLead Sponsor
Canadian Institutes of Health Research (CIHR)Collaborator
References
A systematic review and meta-analysis of randomized controlled trials of cognitive behavior therapy for patients with diabetes and depression. [2018]The aim of this meta-analysis was to systematically examine the efficacy of cognitive behavior therapy (CBT) for diabetic patients who have comorbid depression and to identify which aspects can be improved through intervention.
Group cognitive behavioural therapy and weight regain after diet in type 2 diabetes: results from the randomised controlled POWER trial. [2020]Weight-loss programmes for adults with type 2 diabetes are less effective in the long term owing to regain of weight. Our aim was to determine the 2 year effectiveness of a cognitive behavioural group therapy (group-CBT) programme in weight maintenance after diet-induced weight loss in overweight and obese adults with type 2 diabetes, using a randomised, parallel, non-blinded, pragmatic study design.
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]Patients with diabetes mellitus (DM) have a high risk of secondary physiological and psychological complications. Some interventions based on cognitive behavioral therapy (CBT) have been used to control glucose levels and improve negative emotions of patients with DM. This study was undertaken to provide an overview of the effectiveness of CBT-based interventions for improving glycaemic control, psychological, and physiological outcomes in adult patients with DM.
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]Diabetes is a chronic progressive condition presenting physical, social and psychological challenges that increase the risk of comorbid mental health problems. Cognitive-behavioural therapy (CBT) is effective in treating a variety of psychological disorders, and may potentially improve glycaemic control and psychological outcomes in diabetes. This systematic review and meta-analysis aims to establish the effectiveness of CBT on glycaemic control and comorbid diabetes-related distress, depression, anxiety and quality of life in the short, medium and longer term among adults with diabetes.
Cognitive Behavioral Therapy and Mindfulness-Based Cognitive Therapy in Children and Adolescents with Type 2 Diabetes. [2022]Among adults with type 2 diabetes (T2D), cognitive behavioral therapy (CBT), acceptance and commitment therapy, and mindfulness interventions have demonstrated improvement in depression, anxiety, and glycemic control. We assessed whether these treatment modalities have shown usefulness in adolescents with T2D or at risk for T2D.
Exploring the role of CBT in the self-management of type 2 diabetes: A rapid review. [2023]Type 2 diabetes has been recognised as a global health concern: one that requires intervention to lessen the incumbrance caused by the chronic illness. This rapid review was conducted to determine the scientific evidence available on how Cognitive Behaviour Therapy (CBT) interventions improved the self-management of individuals with type 2 diabetes.
Acceptance-based therapy: the potential to augment behavioral interventions in the treatment of type 2 diabetes. [2022]Diabetes is a complex and multifactorial disease affecting more than 415 million people worldwide. Excess adiposity and modifiable lifestyle factors, such as unhealthy dietary patterns and physical inactivity, can play a significant role in the development of type 2 diabetes. Interventions that implement changes to lifestyle behaviors, in addition to pharmacological treatment, may attenuate the development and worsening of diabetes. This narrative review delineates how standard behavioral interventions (SBTs), based in "first wave" behavioral therapies and "second wave" cognitive behavioral therapies, serve as the foundation of diabetes treatment by supporting effective lifestyle changes, including improving adherence to healthful behaviors, medication, and self-monitoring regimens. Moreover, "third wave" "acceptance-based therapies" (ABTs), which integrate techniques from acceptance and commitment therapy, are proposed as a potential novel treatment option for diabetes management. Further research and long-term, randomized controlled trials will clarify the feasibility, acceptability, and effectiveness of ABT for improving glucose control via enhancing medication adherence and promoting effective lifestyle changes in people with diabetes.