ACT1VATE for Emotional Distress in Type 1 Diabetes
This study, called ACT1VATE, is looking at ways to help adults with type 1 diabetes who are experiencing significant emotional distress and have difficulty managing their blood sugar (HbA1c between 7.0% and 12.5%). It compares two approaches: ACT1VATE, which is a group therapy based on Acceptance and Commitment Therapy (ACT) delivered via telemedicine, and standard diabetes self-management education and support (DSME/S), also delivered via telemedicine. The study aims to see if ACT1VATE can improve blood sugar levels (Glycosylated Hemoglobin or HbA1c) and reduce diabetes-related emotional distress. You may be able to join if you are 18 or older, speak Spanish or English, have type 1 diabetes, and screen positive for diabetes distress. The study plans to enroll 250 people, but its current status is unclear.
- Study design
- This is a randomized controlled trial comparing two behavioral interventions. It plans to enroll 250 adults with type 1 diabetes.
- What's involved
- You would participate in either five 90-minute group telemedicine sessions or one-on-one telemedicine sessions. Your HbA1c and diabetes distress will be measured at baseline, 3, 6, 9, and 12 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be followed for 12 months after starting the study interventions.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Addie Fortmann, PhD · PRINCIPAL_INVESTIGATOR · Scripps Whittier Diabetes Institute
- Athena Philis-Tsimikas, MD · PRINCIPAL_INVESTIGATOR · Scripps Whittier Diabetes Institute
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Glycosylated Hemoglobin (HbA1c)Baseline, 3 months, 6 months, 9 months, 12 months
HbA1c (%) reflects average glucose over the past 2-3 months, with higher values indicating greater risk for developing diabetes-related complications. HbA1c for up to 5 data points (0, 3, 6, 9, 12 months) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine HbA1c changes. Analyses will include the between-subjects factor of group and the within-subjects factor of time. Month 0 will be the referent time-point with post-intervention and follow-up time-points as comparison time-points in dummy-coded predictors. The group by time interaction is of primary interest. If an interaction is found significant, follow-up analyses will determine the nature of differential change between treatment conditions.
- Diabetes Distress ScaleBaseline, 6 months, 12 months
The Type 1 Diabetes Distress Scale (T1-DDS; 28 items averaged to obtain a total score ranging 1-6, with higher scores indicating greater diabetes-related emotional stress) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine change in diabetes distress over time. Analyses will include the between-subjects factor of group and the within-subjects factor of time. Month 0 will be the referent time-point with post-intervention and follow-up time-points as comparison time-points in dummy-coded predictors. The group by time interaction is of primary interest. If an interaction is found significant, follow-up analyses will determine the nature of differential change between treatment conditions.