Health Coaching for Type 2 Diabetes and Mental Health

(TECC-DM Trial)

Overseen By Lucy Kervin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Severe mental illness, others

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

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a virtual health coaching program for individuals with type 2 diabetes who also experience mental health challenges such as anxiety or depression. The program includes weekly coaching calls, support from a diverse care team, and online tools to manage both diabetes and mental health. Participants will receive either this program, known as Technology-Enabled Collaborative Care, or standard diabetes care with educational emails for comparison. This trial suits adults living in Ontario who have type 2 diabetes and mental health symptoms affecting their daily life. As an unphased trial, it offers a unique opportunity to contribute to innovative care solutions that could enhance daily life for many.

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 seems focused on adding virtual health coaching to your existing care.

What prior data suggests that this virtual health coaching program is safe for managing type 2 diabetes and mental health?

Research has shown that the Technology-Enabled Collaborative Care (TECC) model is safe and well-tolerated for people with type 2 diabetes and mental health issues. Studies have found that this program helps individuals actively manage their health without causing harm. Participants in past studies did not report any major side effects. This suggests that the treatment is generally safe, although individual experiences may differ. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Technology-Enabled Collaborative Care for Diabetes and Mental Health (TECC-DM) model is unique because it combines virtual health coaching with an interdisciplinary care team to support individuals with Type 2 diabetes. Unlike standard diabetes treatments, which often rely on medication and in-person visits, this approach delivers personalized care through weekly virtual sessions, utilizing technology like phone, text, and video calls. Researchers are excited about TECC-DM because it aims to improve not just the physical aspects of diabetes management but also mental health and self-care, potentially leading to a better overall quality of life for patients.

What evidence suggests that the Technology-Enabled Collaborative Care program is effective for managing type 2 diabetes and mental health?

Research has shown that the Technology-Enabled Collaborative Care (TECC) program, available to participants in this trial, works well for individuals with type 2 diabetes and mental health issues. Studies have found that this online health coaching model helps individuals manage their diabetes and mental health. It includes weekly coaching sessions and support from a virtual care team. Early results suggest that this method improves quality of life and helps manage symptoms like anxiety and depression. The program is designed to be user-friendly and well-received, making it a promising option for those dealing with both conditions. ^{1 2 3 6 7}

Who Is on the Research Team?

Carly Whitmore, RN PhD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who also face mental health challenges. Participants should be interested in managing their condition using virtual tools and support from a care team. Specific eligibility details are not provided, so it's best to contact the study organizers for more information.

Inclusion Criteria

Experiencing mental health challenges, defined as: Hospital Anxiety and Depression Scale (HADS) score ≥8 on either subscale OR Diabetes Distress Scale (DDS) score ≥2

I am 18 years old or older.

Community-living

Exclusion Criteria

Diagnosis of severe mental illness (e.g., schizophrenia, psychotic disorder)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TECC-DM intervention, which includes weekly virtual health coaching sessions and support from an interdisciplinary care team

12 weeks

12 virtual visits (weekly coaching sessions)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up assessments at 12 weeks and 6 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Technology-Enabled Collaborative Care

Trial Overview The TECC-DM program is being tested, which includes weekly virtual health coaching calls, an interdisciplinary care team's support, and online self-management tools. The goal is to see if this approach helps better than usual healthcare services.

How Is the Trial Designed?

Group I: TECC-DM model Experimental Treatment 1 Intervention

Participants (n=80) are randomized to the TECC-DM arm, a 12-week, relation-driven and integrated model of care delivered virtually in addition to usual diabetes care. Weekly 1-hour sessions with a health coach are supported by guidance from an interdisciplinary virtual care team, using phone, text, Zoom, and REDCap. The program follows a structured protocol to ensure fidelity. TECC-DM is designed to improve quality of life (primary outcome) and goals of care (secondary outcomes: mental health, self-management, and physiological indicators).

Group II: Educational emails Active Control 1 Intervention

Participants (n=80) receive usual diabetes care, which may include primary or specialist care and community-based supports, with services documented to capture variation. In addition, participants receive 10 standardized educational emails over 12 weeks. This arm provides a structured, fidelity-monitored comparison to TECC-DM.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Diabetes Canada

Collaborator

Trials

13

Recruited

1,200+

Centre for Addiction and Mental Health

Collaborator

Trials

388

Recruited

84,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10870944/

Technology-Enabled Collaborative Care for Type-2 ... The TECC-D model is a feasible and scalable care solution that empowers individuals living with T2D and mental health concerns to take an active role in their ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07181863

Technology-Enabled Collaborative Care for Diabetes and ... The purpose of this study is to test the effectiveness of a virtual health coaching program for adults living with type 2 diabetes and mental ...

3. researchprotocols.org researchprotocols.org/2023/1/e39724

Technology-Enabled Collaborative Care for Concurrent ... The intervention will also support people with their mental health symptoms (anxiety or depression) that may arise as a result of their diabetes ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04607915

Technology-enabled Collaborative Care for Diabetes ... In this study, we examine the feasibility of such a program, called the Technology-Enabled Collaborative Care (TECC) for T2DM designed to support patients with ...

5. researchgate.net researchgate.net/publication/378270445_Technology-Enabled_Collaborative_Care_for_Type-2_Diabetes_and_Mental_Health_TECC-D_Findings_From_a_Mixed_Methods_Feasibility_Trial_of_a_Responsive_Co-Designed_Virtual_Health_Coaching_Intervention

(PDF) Technology-Enabled Collaborative Care for Type-2 ... Findings indicate that the program is feasible and acceptable and indicate that there is a role for virtual diabetes and mental health care.

6. journals.sagepub.com journals.sagepub.com/doi/10.1177/20552076251365134

Evaluating the feasibility of a co-designed technology ... Building on the technology-enabled collaborative care (TECC) model, the TECC for young adults living with T1D and diabetes distress (TECC-T1D3) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9890354/

Protocol for a Mixed Methods Feasibility Study - PMC The purpose of this study is to test the feasibility of an innovative co-designed Technology-Enabled Collaborative Care (TECC) model for ...