Recruiting

TECC-DM

Sponsor:

McMaster University

Code:

NCT07181863

Conditions

Type 2 Diabetes

Mental Health

Diabetes Distress

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Health coaching

Educational emails

Study Details

Brief summary:

Managing both type 2 diabetes and mental health challenges can be difficult, and many people do not receive care that supports both. This study looks at how virtual health coaching and support from interdisciplinary care teams can help people better manage their health.

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 health challenges compared to usual care. The Technology-Enabled Collaborative Care for type 2 Diabetes and Mental health (TECC-DM) program includes weekly coaching calls, support from an interdisciplinary care team, and online tools to aid self-management. The findings from this study will be used to help improve services for people who have type 2 diabetes and co-occurring mental health symptoms.

Conditions

Type 2 Diabetes

Mental Health

Diabetes Distress

Study ID

NCT07181863

Start date

Mar 16, 2025

Status verified date

Sep, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults ≥18 years old
  • Diagnosed with type 2 diabetes (T2D)
  • Experiencing mental health challenges, defined as:
  • Hospital Anxiety and Depression Scale (HADS) score ≥8 on either subscale OR
  • Diabetes Distress Scale (DDS) score ≥2
  • Community-living
  • Able to communicate verbally in English
  • Residing in Ontario during study participation

Exclusion Criteria:

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: TECC-DM model

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).

active comparator: Educational emails

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.

Interventions

Health coaching

Health coaching is the active component of TECC-DM. In weekly 1-hour sessions, the coach builds a therapeutic relationship, supports goal-setting and behaviour change, addresses mental health needs, coordinates resources, and empowers participants to navigate care. Coaching is delivered according to a standardized protocol, in consultation with the virtual care team, and targets improvements in quality of life and goals of care. Coaches do not provide pharmacological treatment or replace usual diabetes care.

Educational emails

Participants receive usual diabetes care (e.g., primary care, endocrinology, community supports) plus 10 standardized educational emails over 12 weeks, delivered according to a consistent protocol. Unlike TECC-DM, this approach does not involve a therapeutic relationship, health coach, or interdisciplinary care team.

Primary outcome measure

  • Quality of life [ Time Frame: From baseline to 12 weeks post-intervention and at 6-month follow-up ]

Central Contacts and Locations

Central contacts

Lucy Kervin, PhD

905 525 9140kervinl@mcmaster.ca

Locations

McMaster University

Recruiting

Hamilton, Ontario, Canada, L8S 4K1

Contacts

Lucy Kervin, PhD

905 525 9140teccdm@mcmaster.ca

More Information

Sponsor

McMaster University

Last update posted

Apr 2, 2026

Last verified

Sep, 2025

Keywords

  • type 2 diabetes
  • diabetes distress
  • technology
  • collaborative care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2026-04-02.