Improving outcomes for adults with type 1 diabetes by addressing emotional distress
Official title: ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes
Run by Scripps Whittier Diabetes Institute · NCT04933851 · Data updated 2026-11-12
This study is testing whether a new therapy called 'ACT1VATE' can help adults with type 1 diabetes who are feeling very stressed and have trouble managing their condition, compared to regular diabetes education.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Scripps Whittier Diabetes Institute Academic / other |
| Locations | 1 site (San Diego, California) |
| Status | Recruiting |
| Started | October 25, 2021 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | May 29, 2026 |
| Trial ID | NCT04933851 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Spanish or English-speaking adults with type 1 diabetes and HbA1c levels between 7.5% and 12.5% who are experiencing diabetes-related emotional distress.
✕Probably not a fit
Patients with severe medical or psychological conditions that interfere with participation or those lacking the technology to engage in telemedicine may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial compares a psychological intervention called 'ACT1VATE' with traditional diabetes self-management education and support (DSME/S) to improve health outcomes for adults with poorly controlled type 1 diabetes who are experiencing significant emotional distress. The study will involve 250 participants who will be randomly assigned to either the ACT1VATE group, receiving telemedicine group therapy sessions, or the usual care group, receiving standard diabetes education. The primary outcome measured will be glycosylated hemoglobin (HbA1c) levels, along with assessments of behavioral and psychosocial outcomes through online surveys. The trial aims to leverage electronic health records to identify eligible patients and track outcomes over a 12-month period.
Why it matters
Potential benefit: If successful, this intervention could significantly improve glycemic control and emotional well-being for patients with type 1 diabetes.
How similar studies have gone: Other studies have shown promise in using psychological interventions for chronic conditions, suggesting that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Spanish or English-speaking * Type 1 diabetes * Glycosylated Hemoglobin (HbA1c) 7.0% - 12.5% in last 90 days * 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
Where it's running
-
Scripps Whittier Diabetes Institute
San Diego, California, United States Recruiting
Study contacts
- Principal investigator: Addie Fortmann, PhD — Scripps Whittier Diabetes Institute
- Study coordinator: Haley Sandoval
- Email: sandoval.haley@scrippshealth.org
- Phone: 970-497-6701
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.