RightFit
RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The primary clinical outcome, HbA1c, assessed as part of quarterly standard-of-care medical visits will be extracted from the EHR over 12 months."
  • "Changes in patient-reported behavioral (diabetes self-care) and psychosocial (emotional well-being, quality of life) outcomes will be evaluated via online surveys at baseline, month 6, and month 12."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares ACT1VATE, a program to help with emotional distress, with usual diabetes education and support. It is for adults with type 1 diabetes who have trouble managing their blood sugar and feel significant stress about their diabetes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Speak Spanish or English.
  • Have type 1 diabetes.
  • Have an HbA1c result of 7.0% to 12.5% from the past 90 days. This blood test measures average blood sugar.
  • Have a screening result that shows emotional distress related to diabetes.

Who can't join

  • Have a serious physical or mental health condition that a care provider thinks would prevent you from taking part.
  • Plan to move out of the San Diego area in the next 12 months.
  • Cannot use the technology needed for online surveys and video health visits.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

CA