No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
30 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
University of North Carolina, Chapel Hill · Other
Who this trial is looking for
This trial is looking for adults with type 1 diabetes who experience high levels of diabetes-related distress. Participants will join online group sessions to learn ways to feel better about managing their diabetes.
Are You a Good Fit for This Trial?
You may be able to join if
I am 30 years old or older
I have type 1 diabetes or LADA managed as type 1 diabetes
I have elevated diabetes distress
I speak English
You may not be able to join if
I do not receive diabetes care at UNC Endocrinology at Eastowne
I cannot attend scheduled weekly virtual sessions
I have a major medical or psychiatric condition that prevents participation
I have been diagnosed with dementia or cognitive impairment
I have visual or auditory impairments that interfere with group sessions
I am receiving inpatient psychiatric treatment or have attempted suicide in the past year
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study is designed to compare two behavioral approaches to reduce diabetes distress ("the expected burdens, concerns, fears, and threats that arise from the challenges of living with diabetes") in adults with type 1 diabetes. At the study baseline, participants will be randomized to take part in one of two virtual, group-based interventions (the "Primary" intervention) utilizing either an emot…
This study is designed to compare two behavioral approaches to reduce diabetes distress ("the expected burdens, concerns, fears, and threats that arise from the challenges of living with diabetes") in adults with type 1 diabetes. At the study baseline, participants will be randomized to take part in one of two virtual, group-based interventions (the "Primary" intervention) utilizing either an emotions-focused or a problem-solving approach to reduce diabetes distress. After the initial intervention, participants will complete surveys to assess their response to the material. Participants who are determined to be "non-responders" (i.e., the Primary intervention was not effective) will be re-randomized to one of two "Supplementary" interventions, which will include individualized sessions to learn and/or practice strategies related to either the psychological or problem-solving approach.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adults 30 years and older
* Type 1 diabetes OR latent autoimmune diabetes in adults (LADA) clinically managed as type 1 diabetes
* Elevated diabetes distress, defined as a score \>= 2.0 on the T1-DDAS core scale
* English speaking
Exclusion Criteria:
* Does not receive diabe…
Inclusion Criteria:
* Adults 30 years and older
* Type 1 diabetes OR latent autoimmune diabetes in adults (LADA) clinically managed as type 1 diabetes
* Elevated diabetes distress, defined as a score \>= 2.0 on the T1-DDAS core scale
* English speaking
Exclusion Criteria:
* Does not receive diabetes care at UNC Endocrinology at Eastowne
* Cannot commit to the pre-scheduled weekly, virtual sessions
* Diagnosis of any major medical or psychiatric condition that would preclude participation
* Diagnosis of dementia or other conditions that affect memory or information retention, such as cognitive impairment
* Visual or auditory impairment that would interfere with participation in a group intervention
* Receiving inpatient psychiatric treatment or history of a suicide attempt within the past 12 months at the time of enrollment
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