Clinical trial NCT06028503: ACT Intervention for Type 2 Diabetes Management for Rural and Underserved Community
Official title: Effectiveness of a Community-Based Intervention of Acceptance and Commitment Therapy for Type 2 Diabetes Management in a Rural and Underserved Community
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Sam Houston State University
Sponsor class: OTHER
Collaborators: name: Chelsea Ratcliff, Ph.D.
name: Owen Kelly, Ph.D.,RNutr
name: Oluwaseun Olaiya, DO
name: Michael Griffin, Ph.D.
First posted: 2023-09-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: his study will compare the efficacy of ACT+CGM+LE to CGM+LE, or LE alone, on hemoglobin HbA1c in 60 people with T2D recruited from a rural population.
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to examine the feasibility/acceptability of a one-day Acceptance and Commitment Therapy + Lifestyle Education group intervention paired with 12-weeks of Continuous Glucose Monitoring for patients with type 2 diabetes (T2D) living in rural communities. This study is being designed as a randomized control trial (RCT) comparing ACT+LE+CGM to LE+CGM to LE. The ultimate goal of this line of research is that a community-wide intervention of Acceptance and Commitment Therapy (ACT) with Continuous Glucose Monitoring (CGM) and Lifestyle Education (LE) will improve T2D outcomes in rural communities compared to CGM and LE, or LE alone. Our goal is to develop a scalable and sustainable program for diabetes management in rural areas that enables individual self-management and does not require extensive healthcare resources in an existing medical desert.

Detailed description: ADA guidelines highlight the essential role of nutrition therapy and/or diabetes self-management education (DSME) programs in diabetes management. A recent NHANES analysis which included 2365 people with diabetes indicated that only 32% are considered in good control of diabetes (HbA1c 6.5-6.9%). In the rural community at higher risk of diabetes, conventional lifestyle intervention approaches to diabetes management (e.g., Look AHEAD) or prevention, are not sustainable as they are resource intense. In medical deserts such as rural areas, there is a need for alternative strategies. To add, a mechanism that can impact lack of behavioral adherence is experiential avoidance. Experiential avoidance describes avoiding or escaping behaviors that cause B. distress, anxiety, shame, guilt, pain, and others. Acceptance and Commitment Therapy (ACT) targets experiential avoidance, which many believe prevents engagement in health behavior change. ACT has demonstrated efficacy in numerous psychological and biomedical diseases, including depression and anxiety, migraines, chronic pain, inflammatory bowel disease, weight loss, and T2D. ACT helps patients to overcome avoidance of health behaviors by promoting acceptance of negative feelings and thoughts and by encouraging them to engage in behaviors that align well with their values. Although dietary data suggest people with diabetes may be making self-perceived positive dietary changes, experiential avoidance likely prohibits sustained food behavior change and better self-management.

The purpose of this project is to examine the feasibility/acceptability of a one-day Acceptance and Commitment Therapy + Lifestyle Education group intervention paired with 12-weeks of Continuous Glucose Monitoring for patients with type 2 diabetes (T2D) living in rural communities. This study is being designed as a randomized control trial (RCT) comparing ACT+LE+CGM to LE+CGM to LE. The ultimate goal of this line of research is that a community-wide intervention of Acceptance and Commitment Therapy (ACT) with Continuous Glucose Monitoring (CGM) and Lifestyle Education (LE) will improve T2D outcomes in rural communities compared to CGM and LE, or LE alone. Our goal is to develop a scalable and sustainable program for diabetes management in rural areas that enables individual self-management and does not require extensive healthcare resources in an existing medical desert.

Specific aims:

Aim 1: To implement and adapt (to include CGM monitoring) an abbreviated (one day session) ACT protocol for T2D8 that we can administer at the group level to rural individuals. By the end of the one-day workshop, participants should understand how to use acceptance skills (e.g., mindfulness, cognitive defusion from negative thoughts) to engage in committed action towards T2D management and adherence. Two clinical psychologists, with input from the multidisciplinary team, will adapt the protocol and participant worksheets from existing brief ACT interventions for T2D.

Aim 2: To conduct a pilot single-blind randomized control trial of an adapted ACT for T2D, in combination with CGM and LE, to evaluate the feasibility, acceptability and initial efficacy of this protocol at a among in rural individuals. Therefore, this study will compare the efficacy of ACT+CGM+LE to CGM+LE, or LE alone, on hemoglobin HbA1c in 60 people with T2D recruited from a rural population.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed diabetes (self-reported) and with an HbA1c ≥ 6.0 (using point-of-care device)
2. at least 18 years of age or older
3. able to speak English
4. able to provide informed consent and participate in the study
5. reliable access to a personal smartphone device 6) zip code is associated with a rural area.

Exclusion Criteria:

1. Reported suicidal ideation at the initial visit
2. has evidence of acute psychosis that precludes informed consent
3. appears to be cognitively impaired to the extent that precludes informed consent
4. uses a heavy amount of alcohol or other substances
5. is deemed by the multidisciplinary study team has too medically complex for a more conservative treatment approach
6. has a pacemaker or other implanted electrical medical device
7. Pregnant (management of diabetes while pregnant may require additional medical oversight).
8. Under 18 years old (protocol was validated for adults)
9. Non-English-speaking individuals (protocol has not been translated and validated in other languages)

Primary outcomes:
measure: Reduction in Hemoglobin A1C
timeFrame: 1-year
Secondary outcomes:
measure: Body Mass Index
timeFrame: 1-year
measure: Body Composition
timeFrame: 1-Year
measure: Experiential Avoidance
timeFrame: 1-Year
measure: Depression
timeFrame: 1-Year
measure: Adherence
timeFrame: 1-Year
measure: Food Insecurity
timeFrame: 1-Year
measure: Health literacy
timeFrame: Baseline
Other outcomes:
Locations:
city: Conroe
country: United States
facility: Sam Houston State University College of Osteopathic Medicine
state: Texas
Study officials:
References: