Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06028503
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2023-07-31
Brief Title:
ACT Intervention for Type 2 Diabetes Management for Rural and Underserved Community
Sponsor:
Sam Houston State University
Organization:
Sam Houston State University
Study Overview
Official Title:
Effectiveness of a Community-Based Intervention of Acceptance and Commitment Therapy for Type 2 Diabetes Management in a Rural and Underserved Community
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this project is to examine the feasibilityacceptability 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 ACTLECGM to LECGM 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 andor 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 65-69 In the rural community at higher risk of diabetes conventional lifestyle intervention approaches to diabetes management eg 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 feasibilityacceptability 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 ACTLECGM to LECGM 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 eg 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 ACTCGMLE to CGMLE or LE alone on hemoglobin HbA1c in 60 people with T2D recruited from a rural population
The purpose of this project is to examine the feasibilityacceptability 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 ACTLECGM to LECGM 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 eg 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 ACTCGMLE to CGMLE or LE alone on hemoglobin HbA1c in 60 people with T2D recruited from a rural population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None