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?

This trial explores new ways to help people with type 2 diabetes in rural communities manage their condition more effectively. It compares three approaches: lifestyle education alone, lifestyle education with continuous glucose monitoring (a device that tracks blood sugar levels), and the addition of Acceptance and Commitment Therapy (a type of counseling that aids mental health). The goal is to determine which method most effectively manages diabetes. Individuals diagnosed with type 2 diabetes, who can speak English, and live in a rural area may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes management strategies in rural settings.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Acceptance and Commitment Therapy (ACT), when combined with other treatments for type 2 diabetes, is generally safe. Studies have found that ACT can improve self-care habits and control blood sugar levels. These studies report no specific negative effects from ACT, indicating it is well-tolerated.

Continuous Glucose Monitoring (CGM) is a widely used tool for managing diabetes. CGM devices are generally safe, though users should be aware that sensors might occasionally fall off. This is more of an inconvenience than a safety issue, and replacement sensors are available.

Lifestyle Education (LE) involves learning how lifestyle choices affect blood sugar. It is a safe and non-invasive way to help people make informed decisions about diet and exercise.

Overall, research has not shown significant safety concerns for these components in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Acceptance and Commitment Therapy (ACT) for managing Type 2 Diabetes because it offers a psychological approach that complements existing treatments like medication and lifestyle changes. Unlike traditional diabetes management, which focuses primarily on physical health, ACT helps patients improve their mental and emotional relationship with their condition. This therapy encourages patients to commit to behavior changes by addressing the psychological barriers to managing diabetes, such as stress and anxiety. By combining ACT with continuous glucose monitoring and lifestyle education, this approach aims to provide a more holistic management strategy that could lead to better long-term outcomes for patients.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research has shown that Acceptance and Commitment Therapy (ACT), which participants in this trial may receive, can help people with type 2 diabetes manage their condition more effectively. Studies have found that ACT significantly improves blood sugar control, with an average reduction of 0.95% in HbA1c levels, a measure of long-term blood sugar. Patients reported better self-care habits, essential for managing diabetes. ACT helps individuals come to terms with their condition, leading to better adherence to treatment and improved health. This therapy might also enhance adherence to treatment plans, boosting overall well-being. ^{1 2 6 7 8}

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

Reliable access to a personal smartphone device

Zip code is associated with a rural area.

I can understand and agree to participate in the study.

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

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]

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38546159/

Effectiveness of acceptance and commitment therapy in ... ACT demonstrated significant improvements on patients' glycemic control (mean difference [MD]: 0.95%; p < .001), self-care behaviors (MD: 1.86; ...

2. sigmapubs.onlinelibrary.wiley.com sigmapubs.onlinelibrary.wiley.com/doi/10.1111/wvn.12719

Effectiveness of acceptance and commitment therapy in ... Evidence revealed that there was a statistically significant effect on diabetes acceptance, favoring the ACT interventions (MD: 7.80; 95% CI [ ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212144723001114

Preliminary efficacy of an acceptance-based diabetes ... This pilot study confirmed that ACT-DE programme is an acceptable intervention for people with type 2 diabetes. It demonstrated preliminary efficacy with medium ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8847115/

Efficacy of acceptance and commitment therapy for people ... The results suggested that ACT might reduce HbA1c, and increase self‐care ability and acceptance of people with type 2 diabetes. However, detailed results on ...

5. journals.lww.com journals.lww.com/iahs/fulltext/2020/07020/the_effectiveness_of_acceptance_and_commitment.6.aspx

The Effectiveness of Acceptance and Commitment Therapy ... The results of the data analysis showed that acceptance and commitment therapy is effective in the self-care and adherence to treatment of patients with type 2 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06028503?term=AREA%5BBasicSearch%5D(LE-)&rank=7

Study Details | NCT06028503 | ACT Intervention for Type 2 ... The purpose of this project is to examine the feasibility/acceptability of a one-day Acceptance and Commitment Therapy + Lifestyle Education group intervention ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/jdi.13658

Efficacy of acceptance and commitment therapy for people ... Conclusions. ACT might reduce glycated hemoglobin, and increase self-care ability and acceptance among people with type 2 diabetes.

8. frontiersin.org frontiersin.org/journals/clinical-diabetes-and-healthcare/articles/10.3389/fcdhc.2024.1378946/full

Brief online acceptance and commitment therapy for adults ... CBT emerges as an effective modality for patients with diabetes, leading to notable reductions in hemoglobin A1c levels, fasting blood sugar, ...