Effectiveness of a Community-Based Intervention of Acceptance and Commitment Therapy for Type 2 Diabetes Management in a Rural and Underserved Community
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in Hemoglobin A1C
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The RC will have a shuffled stack of envelopes with a group assignment in each. As participants meet inclusion into the study, their information, including Study ID, will be placed in one of the shuffled envelopes. The envelope will be placed in another envelope and sealed. Once approximately 10 participants are randomized to each group, the RC will contact all participants who have been randomized to share the date and time of the intervention and ask them to complete the 30-minute baseline surveys comprised of self-report measures (located in measures section) that they will receive by email. If recruitment slows down, we will do the randomization once 5 participants express interest in the study. The RC will then send a unique Qualtrics link to each participant (to prevent participants from needing to enter identifying information on the survey). The baseline self-report survey is described below in the Measures section.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Acceptance and Commitment Therapy + Continuous Glucose Monitoring + Lifestyle Education (ACT+CGM+LE)
Participants assigned to ACT+CGM+LE will have both of the above modules in addition to three ACT modules based on Gregg et al.8 and traditional ACT therapy19. Two facilitators will lead the ACT sessions: Dr. Marek or Dr. Ratcliff and one trained doctoral-level clinical psychology student under their direct supervision (i.e., one licensed provider paired with a student). We will run all sessions in a group format. Participants will be given breaks between modules and one long lunch break.
干预措施: Acceptance and Commitment Therapy (Behavioral)
Acceptance and Commitment Therapy + Continuous Glucose Monitoring + Lifestyle Education (ACT+CGM+LE)
Participants assigned to ACT+CGM+LE will have both of the above modules in addition to three ACT modules based on Gregg et al.8 and traditional ACT therapy19. Two facilitators will lead the ACT sessions: Dr. Marek or Dr. Ratcliff and one trained doctoral-level clinical psychology student under their direct supervision (i.e., one licensed provider paired with a student). We will run all sessions in a group format. Participants will be given breaks between modules and one long lunch break.
干预措施: Abbott FreeStyle® Libre® 3 (Device)
Acceptance and Commitment Therapy + Continuous Glucose Monitoring + Lifestyle Education (ACT+CGM+LE)
Participants assigned to ACT+CGM+LE will have both of the above modules in addition to three ACT modules based on Gregg et al.8 and traditional ACT therapy19. Two facilitators will lead the ACT sessions: Dr. Marek or Dr. Ratcliff and one trained doctoral-level clinical psychology student under their direct supervision (i.e., one licensed provider paired with a student). We will run all sessions in a group format. Participants will be given breaks between modules and one long lunch break.
干预措施: Generic Education (Other)
Continuous Glucose Monitoring + Lifestyle Education (CGM+LE)
Participants assigned to CGM+LE will attend the group LE workshop. CGM training will occur after the 5 hour lifestyle education delineated above (same content, but less informal discussion). This will include training on using blood glucose monitoring devices, setting up the App on the smartphone (including activating the hypoglycemic alarm) and how to apply the glucose sensors on the arm. If a sensor does fall off a participant, a member of the study team will provide a spare sensor to the participant. The glucose range for participants will be set at between 70 and 140 mg/dL, unless the study physician (Dr. Olaiya) determines otherwise. The CGM device will allow us to calculate the percentage of 'time in range' per day, peak glucose, nocturnal glucose and number of hypoglycemic events. The CGM training will be managed by Dr. Olaiya and/or Dr. Kelly, and a medical/dietetic students.
干预措施: Abbott FreeStyle® Libre® 3 (Device)
Continuous Glucose Monitoring + Lifestyle Education (CGM+LE)
Participants assigned to CGM+LE will attend the group LE workshop. CGM training will occur after the 5 hour lifestyle education delineated above (same content, but less informal discussion). This will include training on using blood glucose monitoring devices, setting up the App on the smartphone (including activating the hypoglycemic alarm) and how to apply the glucose sensors on the arm. If a sensor does fall off a participant, a member of the study team will provide a spare sensor to the participant. The glucose range for participants will be set at between 70 and 140 mg/dL, unless the study physician (Dr. Olaiya) determines otherwise. The CGM device will allow us to calculate the percentage of 'time in range' per day, peak glucose, nocturnal glucose and number of hypoglycemic events. The CGM training will be managed by Dr. Olaiya and/or Dr. Kelly, and a medical/dietetic students.
干预措施: Generic Education (Other)
Lifestyle Education (LE)
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.
干预措施: Generic Education (Other)
结局指标
主要结局
Reduction in Hemoglobin A1C
时间窗: 1-year
Our goal is to determine if CGM and ACT can change HbA1c 3 months after the intervention and to determine if those reductions can be sustained one year after the intervention.
次要结局
- Body Composition(1-Year)
- Adherence(1-Year)
- Experiential Avoidance(1-Year)
- Depression(1-Year)
- Health literacy(Baseline)
- Body Mass Index(1-year)
- Food Insecurity(1-Year)
研究者
Ryan J Marek, Ph.D.
Assistant Professor of Clinical Psychology
Sam Houston State University