ACT Intervention for Type 2 Diabetes

Overseen By Chelsea Ratcliff, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sam Houston State University

Disqualifiers: Suicidal ideation, Psychosis, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your healthcare provider.

Is Acceptance and Commitment Therapy (ACT) safe for humans?

Acceptance and Commitment Therapy (ACT) has been used safely in various settings for different conditions, including diabetes and mental health issues. It focuses on psychological flexibility, mindfulness, and values, and there is no evidence suggesting it is unsafe for humans. ^{1 2 3 4 5}

How is Acceptance and Commitment Therapy (ACT) different from other treatments for type 2 diabetes?

Acceptance and Commitment Therapy (ACT) is unique because it focuses on psychological flexibility, helping patients with type 2 diabetes accept their thoughts and feelings and commit to actions that align with their values. Unlike traditional treatments that may focus solely on physical symptoms, ACT incorporates mindfulness and values-based living to improve overall well-being. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Acceptance and Commitment Therapy (ACT) for Type 2 Diabetes?

Research shows that people with Type 2 diabetes who used Acceptance and Commitment Therapy (ACT) had better self-care and blood sugar control compared to those who only received education. ACT helps by teaching acceptance and mindfulness skills to manage difficult thoughts and feelings related to diabetes. ^{1 2 3 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with type 2 diabetes, an HbA1c level of at least 6.0, and who live in rural areas. Participants must speak English, be able to give informed consent, and have access to a smartphone.

Inclusion Criteria

I can understand and agree to participate in the study.

Reliable access to a personal smartphone device

Zip code is associated with a rural area.

Exclusion Criteria

Uses a heavy amount of alcohol or other substances

Non-English-speaking individuals (protocol has not been translated and validated in other languages)

I am able to understand and give consent for my treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo a one-day Acceptance and Commitment Therapy + Lifestyle Education group intervention followed by 12 weeks of Continuous Glucose Monitoring

12 weeks

1 visit (in-person) for the workshop, ongoing monitoring

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including assessment of HbA1c and other secondary outcomes

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Acceptance and Commitment Therapy

Trial Overview The study tests if Acceptance and Commitment Therapy (ACT) plus Lifestyle Education (LE), combined with Continuous Glucose Monitoring (CGM), can help manage type 2 diabetes better than just CGM and LE or LE alone in rural communities.

How Is the Trial Designed?

Group I: Continuous Glucose Monitoring + Lifestyle Education (CGM+LE) Experimental Treatment 2 Interventions

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.

Group II: Acceptance and Commitment Therapy + Continuous Glucose Monitoring + Lifestyle Education (ACT+CGM+LE) Experimental Treatment 3 Interventions

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.

Group III: Lifestyle Education (LE) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Sam Houston State University

Lead Sponsor

Trials

6

Recruited

1,200+

Chelsea Ratcliff, Ph.D.

Collaborator

Trials

1

Recruited

60+

Michael Griffin, Ph.D.

Collaborator

Trials

1

Recruited

60+

Owen Kelly, Ph.D.,RNutr

Collaborator

Trials

1

Recruited

60+

Oluwaseun Olaiya, DO

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

Acceptance and Commitment Therapy (ACT) significantly reduced glycated hemoglobin levels in people with type 2 diabetes, indicating improved blood sugar control, based on a meta-analysis of three trials.

ACT also enhanced self-care abilities related to diabetes management, as evidenced by a higher score on the summary of diabetes self-care activities, suggesting it can be an effective psychological intervention for diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of acceptance and commitment therapy for people with type 2 diabetes: Systematic review and meta-analysis. Sakamoto, R., Ohtake, Y., Kataoka, Y., et al.[2022]

In a study of 211 Japanese patients with type 2 diabetes, those exhibiting high levels of acceptance, mindfulness, and values (the 'Flexibility' cluster) reported significantly fewer depressive symptoms, highlighting the importance of psychological flexibility in diabetes management.

However, patients in the 'Values/high' cluster, while having fewer depressive symptoms, showed higher glycated hemoglobin levels, suggesting that while values are important, a balance with acceptance and mindfulness is crucial for effective diabetes treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The patterns of acceptance, mindfulness, and values for Japanese patients with type 2 diabetes mellitus: a web-based survey. Saito, J., Kumano, H.[2022]

The ACTonDiabetes internet intervention showed feasibility in reducing diabetes distress among participants, with a significant reduction observed in the intervention group (d=0.65, p=0.042) after 8 weeks.

Despite a 43% completion rate of the treatment modules, 57% of participants dropped out before finishing, indicating a need for improvements in content comprehensibility and individualization to enhance adherence in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACTonDiabetes-a guided psychological internet intervention based on Acceptance and Commitment Therapy (ACT) for adults living with type 1 or 2 diabetes: results of a randomised controlled feasibility trial. Bendig, E., Bauereiss, N., Schmitt, A., et al.[2021]

In a study of 81 low-income patients with Type 2 diabetes, those who received a combination of diabetes education and acceptance and commitment therapy (ACT) showed better self-care and improved HbA1c levels after 3 months compared to those who received education alone.

The use of acceptance and mindfulness skills in the ACT group helped mediate the positive effects on diabetes management, indicating that psychological strategies can enhance physical health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving diabetes self-management through acceptance, mindfulness, and values: a randomized controlled trial. Gregg, JA., Callaghan, GM., Hayes, SC., et al.[2022]

Internet-based Acceptance and Commitment Therapy (iACT) shows small effects in reducing depressive symptoms, anxiety, stress, psychological distress, and improving quality of life, based on a systematic review of 39 randomized controlled trials.

While iACT was effective compared to passive control groups, it did not show significant advantages over active control groups, indicating the need for further high-quality studies to compare its efficacy with other established therapies like cognitive behavioral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Internet-Based Acceptance and Commitment Therapy for Depressive Symptoms, Anxiety, Stress, Psychological Distress, and Quality of Life: Systematic Review and Meta-analysis. Han, A., Kim, TH.[2022]

Acceptance and Commitment Therapy (ACT) is a promising form of therapy that incorporates mindfulness techniques and has shown effectiveness for various psychiatric disorders in adults.

Research on adapting ACT for youth is still developing, indicating a need for more studies to establish its efficacy and safety in younger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy (ACT): advances and applications with children, adolescents, and families. Coyne, LW., McHugh, L., Martinez, ER.[2011]

Lifestyle changes, supported by standard behavioral interventions and cognitive behavioral therapies, are crucial in managing type 2 diabetes and can enhance adherence to healthy behaviors and medication regimens.

The review suggests that acceptance-based therapies (ABTs) could be a promising new approach for diabetes management, but further research is needed to confirm their effectiveness in improving glucose control and promoting lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance-based therapy: the potential to augment behavioral interventions in the treatment of type 2 diabetes. Cardel, MI., Ross, KM., Butryn, M., et al.[2022]

A study involving 18 participants receiving renal dialysis successfully adapted Acceptance and Commitment Therapy (ACT) materials to better meet their needs, emphasizing the importance of patient consultation in intervention design.

Feedback from patients indicated a preference for video presentations narrated by real dialysis patients, leading to a more structured and relatable intervention that maintains the core principles of ACT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using patient feedback to adapt intervention materials based on acceptance and commitment therapy for people receiving renal dialysis. Elander, J., Kapadi, R., Coyne, E., et al.[2022]

In a pilot study involving young adult females, those who participated in Acceptance and Commitment Therapy (ACT) showed a significant increase in physical activity compared to those who received an Education intervention.

The ACT intervention, which included mindfulness and values clarification techniques, suggests that this therapeutic approach can effectively promote short-term behavior change related to physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of acceptance and commitment therapy for promotion of physical activity. Butryn, ML., Forman, E., Hoffman, K., et al.[2022]

Citations

1. Japan pubmed.ncbi.nlm.nih.gov

Efficacy of acceptance and commitment therapy for people with type 2 diabetes: Systematic review and meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The patterns of acceptance, mindfulness, and values for Japanese patients with type 2 diabetes mellitus: a web-based survey. [2022]

3. England pubmed.ncbi.nlm.nih.gov

ACTonDiabetes-a guided psychological internet intervention based on Acceptance and Commitment Therapy (ACT) for adults living with type 1 or 2 diabetes: results of a randomised controlled feasibility trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Improving diabetes self-management through acceptance, mindfulness, and values: a randomized controlled trial. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Efficacy of Internet-Based Acceptance and Commitment Therapy for Depressive Symptoms, Anxiety, Stress, Psychological Distress, and Quality of Life: Systematic Review and Meta-analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy (ACT): advances and applications with children, adolescents, and families. [2011]

7. England pubmed.ncbi.nlm.nih.gov

Acceptance-based therapy: the potential to augment behavioral interventions in the treatment of type 2 diabetes. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Using patient feedback to adapt intervention materials based on acceptance and commitment therapy for people receiving renal dialysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A pilot study of acceptance and commitment therapy for promotion of physical activity. [2022]