Testing an Integrated Care Model Trial

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Evaluating the Integration of Mental Health Care Into the Treatment of Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06448429
• Other study ID #: STUDY00007247
• Status: Recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: January 2026

Study information

• Verified date: June 2024
• Source: Emory University
• Contact: Leslie Johnson, PhD, MPH
• Phone: 770-800-7085
• Email: lmunoz[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to test the use of an adapted collaborative care model for improving the health outcomes of adults diagnosed with type 1 diabetes (T1D). The duration of the study is 18 months with 4 study survey points. Participants will fill out an online survey regarding their psychosocial health and chronic disease management behaviors once every six months over the 18 months, and individuals who are randomly assigned to the study intervention will also consult at least once with a behavioral health consultant during the first year (active intervention period).

Description:

Type 1 diabetes (T1D) is a lifelong condition that requires consistent monitoring and management, increasing people's risk for common mental disorders that worsen diabetes self-care. Both depression and diabetes can be managed with behavioral interventions, however, they are rarely provided alongside routine diabetes care for people with T1D. In this research study, the investigators aim to evaluate the implementation and effectiveness outcomes of a collaborative care model that uses a Behavioral Health Consultant (BHC) to support lifestyle management among adults with T1D receiving diabetes care at the Grady Diabetes Clinic.

A trained clinical research coordinator will screen interested patients seeking treatment at the Grady Diabetes Center and conduct outreach to individuals who have been identified as having T1D within the Grady Diabetes Center's patient population.

Participants in the intervention group will engage with a behavioral health consultant (BHC) not affiliated with Grady who will work with them to establish personalized health goals and identify ways to manage stress and promote healthy behaviors as means to support their mental and physical health and meet their set goals (i.e., behavioral activation). Each session will be conducted over the telephone or Zoom and last 30-60 minutes, with the number and frequency of meetings established through discussions between the patient and BHC (typically 2-3 sessions for one year). Checklist and summary case reporting templates will be used to track intervention fidelity. The BHC will also participate in ongoing Zoom calls with the multi-disciplinary T1D clinical team at the Grady Diabetes Center once a month to provide updates on patients' behavioral health plans. Transitioning patients from the active intervention will involve discussions with the care team to ensure continued patient support. In cases of active suicidal ideation, the study team will notify the patient's usual diabetes care provider and the individual will be referred to psychiatric services at Grady.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (=18 years) with T1D (based on clinical record diagnosis).

Exclusion Criteria:

• Patients who do not speak English or have reliable telephone access will be excluded. ---

• Individuals with the presence of severe psychiatric illness (PHQ-9=20) or active suicidal ideation will also be excluded and referred to specialty care.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Other:
• Usual care
Participants will have the usual diabetes care at the Grady Diabetes Clinic.
• Collaborative care model (CoCM)
Collaborative care will include: Care with a behavioral health consultant (BHC) Measurement-based mental health care Systematic caseload reviews Medical management of depression The BHC will monitor depression and anxiety severity, promote behavioral change with patients through Behavioral Activation, and support the medical management of depression through participation in caseload reviews (I.e., Mental health care plans for individual patients will be reviewed monthly by a multi-disciplinary T1D clinical team and BHC). Depression treatment initiation (if warranted) by a clinician and engagement in mental health care.

Locations

Country	Name	City	State
United States	Grady Health System	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	Juvenile Diabetes Research Foundation, MQ Mental Health Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving improvements in PHQ-9 score	Participants will be considered as having an improvement in PHQ-9 score if PHQ-9=10	Baseline and 12 months
Primary	Proportion of patients achieving improvement in HbA1c at end of intervention	Improvement in HbA1c will be considered as HbA1c<7 or =0.5% HbA1c reduction	Baseline and 12 months
Secondary	Generalized anxiety disorder scale score	Researchers will use the Generalized anxiety disorder (GAD)-7, a 7-item scale with reporting scores from 0 to 3 on all the questions. It investigates how often the patient has been bothered by seven different symptoms of anxiety during the last two weeks with response options such as: " not at all," " several days '," more than half the days," and " nearly daily " scored as 0, 1, 2, and 3, respectively. The GAD-7 is scored by adding the scores for all 7 items, giving a total score from 0 to 21. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate, and severe anxiety, respectively. Further evaluation is recommended when the score is 10 or greater.	Baseline and 12 months
Secondary	Systolic and diastolic blood pressure (BP) measurements	Systolic and diastolic blood pressure (SBP and DBP) will be extracted from participants' medical records.	Baseline and 12 months
Secondary	Low-density lipoprotein (LDL) cholesterol	LDL cholesterol data will be extracted from participants' medical records.	Baseline and 12 months