Psychological Intervention for Type 1 Diabetes

Overseen By Haley Sandoval

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Scripps Whittier Diabetes Institute

Disqualifiers: Severe medical, psychological conditions, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 5 sessions over 6 months

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new psychological program called ACT1VATE, designed to assist people with type 1 diabetes who feel emotionally drained by their condition. The trial aims to determine if ACT1VATE can improve emotional well-being and blood sugar control more effectively than standard care, which involves diabetes self-management education and support (DSME/S). Individuals with type 1 diabetes who experience significant emotional stress related to their condition and have recently struggled with blood sugar control might be suitable for this trial. Participants will either try the new program or continue with usual care to compare results. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Research has shown that ACT1VATE is a new psychological treatment designed to help people with type 1 diabetes who feel stressed about their condition. Although still under study, it aims to improve emotional well-being, which can aid in better diabetes management.

As a psychological treatment, ACT1VATE does not involve new medications or physical procedures, typically resulting in fewer risks of physical side effects. Psychological treatments like ACT1VATE are generally considered safe and well-tolerated by participants. However, as it remains in the middle stage of clinical trials, researchers are gathering more information to fully confirm its safety and effectiveness.

In summary, while ACT1VATE is still being tested, psychological treatments usually pose less risk compared to new drugs. Participants can expect a focus on emotional support, which might help in managing diabetes more effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ACT1VATE because it offers a fresh approach to managing the emotional challenges of living with Type 1 diabetes. Unlike standard treatments that focus on diabetes self-management education and support (DSME/S), ACT1VATE is specifically designed to tackle diabetes-related emotional distress through psychological intervention. This approach could potentially enhance overall well-being and improve diabetes management by addressing the emotional hurdles that often accompany the condition.

What evidence suggests that this trial's treatments could be effective for type 1 diabetes?

Research shows that psychological treatments can help manage emotional stress in people with type 1 diabetes (T1D). In this trial, participants may receive ACT1VATE, a psychological intervention specifically designed to address diabetes-related emotional distress. Studies have found that reducing emotional stress can lead to better blood sugar control. Although specific data on ACT1VATE is limited, similar methods have improved both mental health and diabetes management. This suggests that ACT1VATE might help people feel better and manage their diabetes more effectively. Another group in this trial will receive DSME/S, the standard diabetes self-management education and support, to compare its effectiveness with ACT1VATE. ^{1 2 4 5 6}

Who Is on the Research Team?

Athena Philis-Tsimikas, MD

Principal Investigator

Scripps Whittier Diabetes Institute

Addie Fortmann, PhD

Principal Investigator

Scripps Whittier Diabetes Institute

Are You a Good Fit for This Trial?

This trial is for adults with Type 1 Diabetes who feel very stressed about their diabetes and have high blood sugar levels (HbA1c ≥ 8% in the last 90 days). They must speak English or Spanish, be a patient at Scripps Health, and plan to stay in San Diego for the next year. People with severe health or mental issues that could affect participation are not eligible.

Inclusion Criteria

Glycosylated Hemoglobin (HbA1c) between 7.5% and 12.5% in the last 90 days

I have been diagnosed with Type 1 diabetes.

Screen positive for diabetes distress

Exclusion Criteria

Severe medical or psychological conditions that would interfere with participation based on the opinion of a provider

Plans to move out of the San Diego area in the next 12 months

Lack of technology capability required to complete online surveys and telemedicine visit

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the ACT1VATE psychological intervention or DSME/S usual care via telemedicine

5 sessions over 6 months

5 group-therapy sessions (virtual) for ACT1VATE group

Follow-up

Participants are monitored for changes in glycemic control and emotional distress

12 months

Quarterly standard-of-care medical visits

Process Evaluation

Evaluation of reach, acceptability, feasibility, adoption, maintenance, and fidelity of the intervention

12 months

What Are the Treatments Tested in This Trial?

Interventions

• ACT1VATE
• DSME/S

Trial Overview The study compares 'ACT1VATE', a psychological intervention aimed at reducing stress related to diabetes, against standard diabetes education and support (DSME/S) to see which is better at improving control of blood sugar levels and overall well-being among patients.

How Is the Trial Designed?

Group I: ACT1VATE Experimental Treatment 1 Intervention

Participants assigned to the intervention group will be offered a psychological intervention specifically designed to address diabetes-related emotional distress.

Group II: DSME/S (usual care) Active Control 1 Intervention

Participants randomized to the usual care group will be offered standard diabetes self-management education and support (DSME/S).

Who Is Running the Clinical Trial?

Scripps Whittier Diabetes Institute

Lead Sponsor

Trials

19

Recruited

5,400+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A study involving 305 U.S. adults with type 1 diabetes identified seven key sources of diabetes distress, including Powerlessness and Hypoglycemia Distress, which were confirmed in a separate sample of 109 Canadian participants.

The prevalence of diabetes distress was notably high, with 41.6% of participants experiencing at least moderate distress, particularly among women, younger individuals, and those with poor glycemic control, highlighting the need for targeted support in clinical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the sources of diabetes distress in adults with type 1 diabetes. Fisher, L., Polonsky, WH., Hessler, DM., et al.[2022]

Targeted interventions significantly reduced diabetes distress in adults with Type 1 diabetes, with an average decrease of 0.6 points in the intervention group compared to only 0.2 points in the untreated group, indicating the efficacy of the intervention.

Without treatment, over half (51%) of individuals with elevated diabetes distress continued to experience high levels of distress after 9 months, highlighting that untreated diabetes distress tends to remain chronic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

There is value in treating elevated levels of diabetes distress: the clinical impact of targeted interventions in adults with Type 1 diabetes. Hessler, D., Fisher, L., Polonsky, W., et al.[2022]

In a study involving 301 adults with type 1 diabetes, reductions in diabetes distress were linked to improved self-care behaviors, such as better insulin management and increased blood glucose monitoring, which are crucial for effective diabetes management.

The improvements in self-care behaviors subsequently led to better glycemic outcomes, including lower HbA1c levels and fewer hypoglycemic episodes, highlighting the importance of addressing diabetes distress to enhance overall diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reductions in Management Distress Following a Randomized Distress Intervention Are Associated With Improved Diabetes Behavioral and Glycemic Outcomes Over Time. Hessler, D., Strycker, L., Fisher, L.[2022]

Both the OnTrack (emotion-focused) and KnowIt (educational/behavioral) interventions significantly reduced diabetes distress (DD) among 301 adults with type 1 diabetes, with an effect size indicating a strong impact, but no significant differences in effectiveness between the two methods.

While both interventions led to modest improvements in glycemic control (HbA1c), the reduction in DD was only weakly associated with changes in HbA1c, suggesting that addressing emotional and cognitive factors is crucial for effective diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

T1-REDEEM: A Randomized Controlled Trial to Reduce Diabetes Distress Among Adults With Type 1 Diabetes. Fisher, L., Hessler, D., Polonsky, WH., et al.[2022]

The Type 1 Diabetes Distress Scale (T1-DDS) was validated in a large sample of 2201 adults with Type 1 diabetes in Denmark, showing good content and construct validity for assessing diabetes-related distress.

The T1-DDS demonstrated a strong correlation with the Problem Areas In Diabetes scale (PAID-20) and good reliability in retest scores, but the study also revealed that it does not encompass all potential stressors faced by individuals with Type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the type 1 diabetes distress scale (T1-DDS) in a large Danish cohort: Content validation and psychometric properties. Joensen, LE., Lindgreen, P., Olesen, K., et al.[2023]

The FEEL-T1D study is investigating the relationships between blood glucose levels, emotional well-being, and functional ability in 200 adults with type 1 diabetes, using remote data collection methods including continuous glucose monitoring and ecological momentary assessments.

As of June 2021, the study has successfully enrolled 124 participants and achieved high completion rates for data collection, indicating that the remote study design has been effective, especially during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Function and Emotion in Everyday Life With Type 1 Diabetes (FEEL-T1D): Protocol for a Fully Remote Intensive Longitudinal Study. Pyatak, EA., Hernandez, R., Pham, LT., et al.[2023]

Psychological interventions, such as counseling and cognitive behavior therapy, significantly reduced glycated hemoglobin levels in children and adolescents with type 1 diabetes, indicating improved glycaemic control.

In contrast, these psychological therapies did not show a significant effect on glycaemic control in adults with type 1 diabetes, although they did help reduce psychological distress in younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological interventions to improve glycaemic control in patients with type 1 diabetes: systematic review and meta-analysis of randomised controlled trials. Winkley, K., Ismail, K., Landau, S., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39265782/

Protocol for ACT1VATE randomized controlled trial - PubMed The purpose of this in-progress trial is to compare an ACT group intervention (ACT1VATE) with usual care in improving HbA1c, DD, quality of life, and cost- ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04933851

ACT1VATE: Addressing Emotional Distress to Improve ... This research will compare a psychological intervention ("ACT1VATE") versus diabetes self-management education and support (DSME/S; usual care) in improving ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424002702

Protocol for ACT1VATE randomized controlled trial The purpose of this in-progress trial is to compare an ACT group intervention (ACT1VATE) with usual care in improving HbA1c, DD, quality of life, and cost- ...

4. trialx.com trialx.com/clinical-trials/listings/282250/act1vate-addressing-emotional-distress-to-improve-outcomes-among-diverse-adults-with-type-1-diabetes/?&geo_lat=32.8328112&geo_lng=-117.2712717&radius=10&place=La%20Jolla&user_country=United%20States

ACT1VATE: Addressing Emotional Distress to Improve ... This research will compare a psychological intervention ("ACT1VATE") versus diabetes self-management education and support (DSME/S; usual care) ...

5. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/376935

ACT1VATE: Addressing Emotional Distress to Improve ... This research will compare a psychological intervention ("ACT1VATE") versus diabetes self-management education and support (DSME/S; usual care) in improving ...

6. sciencedirect.com sciencedirect.com/science/article/am/pii/S1551714424002702

Protocol for ACT1VATE Randomized Controlled As DD is highly prevalent, with an estimated 42% of adults with type 1 diabetes (T1D) reporting clinically significant DD (4), there have been efforts to ...