NCT06028503Recruiting
ACT Intervention for Type 2 Diabetes Management for Rural and Underserved Community
Effectiveness of a Community-Based Intervention of Acceptance and Commitment Therapy for Type 2 Diabetes Management in a Rural and Underserved Community
Source: ClinicalTrials.gov · Last updated 15 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 31 Jul 2023
- Start date
- 1 Apr 2024
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Sam Houston State University
- Diseases
- Type 2 diabetes
- NCT number
- NCT06028503
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Apr 2024 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Pregnant (management of diabetes while pregnant may require additional medical oversight).
Age
- Under 18 years old (protocol was validated for adults)
Other
- 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
- Non-English-speaking individuals (protocol has not been translated and validated in other languages)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sam Houston State University College of Osteopathic Medicine Coordinator of this site? Confirm its status | Conroe | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.