RecruitingPhase 2NCT04933851

ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes

Sponsor

Scripps Whittier Diabetes Institute

Enrollment

250 participants

Start Date

Oct 25, 2021

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes

Summary

This research will compare a psychological intervention ("ACT1VATE") versus diabetes self-management education and support (DSME/S; usual care) in improving clinical, behavioral, psychosocial, process, and cost outcomes among adults with poorly controlled type 1 diabetes (T1D) who are experiencing significant diabetes-related emotional distress and poor glycemic control in a real world, healthcare environment.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a program called ACT1VATE that uses Acceptance and Commitment Therapy (a type of talk therapy) delivered via telemedicine to help adults with type 1 diabetes who are struggling emotionally with managing their condition improve their blood sugar control. **You may be eligible if...** - You have type 1 diabetes - Your blood sugar is not well controlled (HbA1c between 7.5% and 12.5% in the last 3 months) - You have screened positive for diabetes-related emotional distress - You speak English or Spanish - You are able to use online technology for surveys and video appointments **You may NOT be eligible if...** - You have a severe medical or psychological condition that would interfere with participation - You plan to move out of the San Diego area within the next 12 months - You do not have the technology needed for telemedicine visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALACT1VATE

ACT1VATE, informed by Acceptance and Commitment Therapy (ACT), will consist of five, 90-minute group-based telemedicine therapy sessions delivered by a Behavioral Health Provider.

BEHAVIORALDSME/S

Diabetes self-management education and support (DSME/S) will be delivered by a Certified Diabetes Care and Education Specialist via one-on-one telemedicine format.

Locations(1)

Scripps Whittier Diabetes Institute

San Diego, California, United States

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NCT04933851

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