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Recruiting NCT06028503

ACT Intervention for Type 2 Diabetes Management for Rural and Underserved Community

No phase Interventional Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acceptance and Commitment Therapy, Abbott FreeStyle® Libre® 3, Generic Education.
Who it may be relevant to
Registry conditions: Type 2 Diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effectiveness of a Community-Based Intervention of Acceptance and Commitment Therapy for Type 2 Diabetes Management in a Rural and Underserved Community

Overview

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.

Interventions

  • Behavioral Acceptance and Commitment Therapy
    Approximately 3 hours of ACT will be administered based on Gregg et al.;s (2007) protocol: 1. What is ACT? 2. Coping and Stress Management 3. Acceptance and Action
  • Device Abbott FreeStyle® Libre® 3
    The Abbott FreeStyle® Libre® 3 (FDA approved) consists of a single use disposable electrochemical sensing unit which is placed on the upper arm and an App for smart phones where the participant can view their glucose data, including their current glucose reading, their 'trend arrow' so participants can see how glucose is changing, and their glucose history. The FreeStyle system does not require user calibration. A sensor log will be maintained for accountability of all sensors received as well a
  • Other Generic Education
    Participants will be given information about how lifestyle choices, including daily dietary choices, affect blood sugar for people with T2D, and best practices related to checking blood sugar and carbohydrate counting if participants are on insulin therapy. These sessions will also include education on diabetes nutrition guidelines and improving self-management through better food and lifestyle choices.

Primary outcome measures

  • Reduction in Hemoglobin A1C [Time frame: 1-year]
Secondary outcome measures (7)
  • Body Mass Index [Time frame: 1-year]
  • Body Composition [Time frame: 1-Year]
  • Experiential Avoidance [Time frame: 1-Year]
  • Depression [Time frame: 1-Year]
  • Adherence [Time frame: 1-Year]
  • Food Insecurity [Time frame: 1-Year]
  • Health literacy [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Sam Houston State University College of Osteopathic Medicine — Conroe

Identifiers

NCT: NCT06028503 · IRB-2023-194

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗