Technology-Enabled Collaborative Care for Diabetes and Mental Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMcMaster University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ≥18 years old
Diagnosed with type 2 diabetes (T2D)
Hospital Anxiety and Depression Scale (HADS) score ≥8 on either subscale OR
Diabetes Distress Scale (DDS) score ≥2
Disqualifiers
Diagnosis of severe mental illness (e.g., schizophrenia, psychotic disorder)
Trial design
Design model
Parallel
Treatments tested in this trial
Health coaching
BehavioralHealth 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
Other interventionParticipants 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: TECC-DM modelExperimental treatment 1 intervention
Group B: Educational emailsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Quality of life
Quality of life refers to an individual's overall well-being, encompassing physical, mental, emotional, and social dimensions of health. In this study, it is measured using the EuroQol-5D (EQ-5D), which captures participants' perceptions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Unit of Measure: EQ-5D-5L index score. Minimum Value: 0 (the worst possible health state). Maximum Value: 100 (the best possible health state). Interpretation: Higher scores indicate better health-related quality of life.
Time frame
From baseline to 12 weeks post-intervention and at 6-month follow-upSecondary outcomes
1
Change in diabetes distress score (Diabetes Distress Scale, DDS)
The DDS measures the emotional burden, regimen distress, interpersonal distress, and physician distress related to living with diabetes. Scores range from 1-6, with higher scores indicating greater distress. Outcome will be reported as mean change in total and subscale scores from baseline to 12 weeks and 6 months, with the proportion of participants achieving a clinically meaningful reduction (≥0.5 points) also reported.
Time frame
From baseline to 12 weeks post-intervention and at 6-month follow-up2
Change in psychological and behavioural health symptoms (Global Appraisal of Individual Needs Short Screener, GAIN-SS)
The GAIN-SS is a validated screener for internalizing and externalizing disorders, substance use, and crime/violence problems. Scores range from 0-15 per subscale, with higher scores indicating more symptoms. Outcome will be reported as change in total and domain scores from baseline to 12 weeks and 6 months, along with the number of participants with reduced symptom severity.
Time frame
From baseline to 12 weeks post-intervention and at 6-month follow-up3
Change in perceived stress score (Perceived Stress Scale, PSS)
The PSS measures the degree to which situations in one's life are appraised as stressful, with scores ranging from 0-40. Higher scores indicate greater perceived stress. Outcome will be reported as change in mean score from baseline to 12 weeks and 6 months, with distribution of participants across mild, moderate, and high stress categories also described.
Time frame
From baseline to 12 weeks post-intervention and at 6-month follow-up4
Change in depressive symptoms (Patient Health Questionnaire, PHQ-9)
The PHQ-9 measures the presence and severity of depressive symptoms, with scores ranging from 0-27. Higher scores indicate more severe depression. Outcome will be reported as change in mean score from baseline to 12 weeks and 6 months, and the proportion of participants achieving clinically significant improvement (≥5-point reduction or remission, score \<5).
Time frame
From baseline to 12 weeks post-intervention and at 6-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
McMaster University
Lead sponsor
Centre for Addiction and Mental Health
Collaborator
Diabetes Canada
Collaborator
Source ClinicalTrials.gov