Acceptance and Commitment Therapy for managing Type 2 Diabetes in rural communities
Effectiveness of a Community-Based Intervention of Acceptance and Commitment Therapy for Type 2 Diabetes Management in a Rural and Underserved Community
This study is testing a new one-day program that combines therapy and lifestyle education to help people with Type 2 Diabetes in rural areas better manage their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sam Houston State University Academic / other |
| Locations | 1 site (Conroe, Texas) |
| Trial ID | NCT06028503 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the feasibility and acceptability of a one-day Acceptance and Commitment Therapy (ACT) combined with Lifestyle Education (LE) and Continuous Glucose Monitoring (CGM) for individuals with Type 2 Diabetes (T2D) living in rural areas. The study will be conducted as a randomized control trial comparing the combined intervention to LE with CGM and LE alone. The goal is to develop a sustainable diabetes management program that empowers individuals to self-manage their condition without requiring extensive healthcare resources. By addressing experiential avoidance, the intervention seeks to improve adherence to health behaviors and ultimately enhance diabetes outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a self-reported diagnosis of diabetes and an HbA1c of 6.0 or higher, residing in rural areas.
Not a fit: Patients with acute psychosis, severe cognitive impairment, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve diabetes management and health outcomes for patients in rural communities.
How similar studies have performed: While ACT has shown efficacy in various health conditions, this specific combination of ACT, CGM, and LE in rural diabetes management is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Conroe, Texas
- Sam Houston State University College of Osteopathic Medicine — Conroe, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Ryan J Marek, Ph.D.
- Email: rxm147@shsu.edu
- Phone: (936)294-3614
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.