Clinical trial NCT06448429: Testing an Integrated Care Model Trial
Official title: Evaluating the Integration of Mental Health Care Into the Treatment of Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Behavioral Health
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: MQ Mental Health Research
name: Juvenile Diabetes Research Foundation
First posted: 2024-06-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients achieving improvements in PHQ-9 score
timeFrame: Baseline and 12 months
measure: Proportion of patients achieving improvement in HbA1c at end of intervention
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Generalized anxiety disorder scale score
timeFrame: Baseline and 12 months
measure: Systolic and diastolic blood pressure (BP) measurements
timeFrame: Baseline and 12 months
measure: Low-density lipoprotein (LDL) cholesterol
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
Study officials:
affiliation: Emory University
name: Leslie Johnson, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: