Telemedicine-Delivered Therapy for Anxiety and Depression in Type 1 Diabetes
This study is testing a telemedicine-delivered therapy called Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) combined with Continuous Glucose Monitoring (CGM) for adults with type 1 diabetes who also experience anxiety or depression. The goal is to see if adding UP-CBT improves anxiety and depression symptoms, as well as blood sugar control. You might be able to join if you are 18-64 years old, have had type 1 diabetes for at least 6 months, and have been diagnosed with an anxiety or depressive mood disorder. The study aims to enroll 94 participants and is comparing UP-CBT plus CGM to CGM alone. Researchers will measure changes in anxiety and depression symptoms over 12 months to see if the treatment is successful.
- Study design
- This is an interventional study comparing UP-CBT combined with CGM to CGM alone, involving 94 participants. It is a randomized controlled clinical trial.
- What's involved
- You would participate in approximately 16 individual UP-CBT sessions over about 20 weeks. You would also use a CGM for 6 months and continue usual diabetes care.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your anxiety and depressive symptoms will be measured at 3 months, 5.5 months, 9 months, and 12 months after the study starts.
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Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Jeffrey Gonzalez, PhD · PRINCIPAL_INVESTIGATOR · Albert Einstein College of Medicine
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Anxiety symptom severityBaseline and midway through treatment (3 months), immediately post-treatment (5.5 months) and 9- and 12- months post-baseline
Participant ratings will be conducted via video conference by clinicians blinded to the condition, using the Structured Interview Guide for the Hamilton Anxiety Rating Scales (SIGH-A). SIGH-A measures the severity of a patient's somatic and psychic anxiety based on 14 parameters including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview. Each item is assigned a 5-point score ranging from 0 (not present) to 4 (severe) yielding an overall possible score of 0-56. Higher SIGH-A scores denote increased severity of anxiety.
- Depressive symptom severityBaseline and midway through treatment (3 months), immediately post-treatment (5.5 months) and 9- and 12- months post-baseline
Participant ratings will be conducted via video conference by clinicians blinded to the condition, using the Structured Interview Guide for the Hamilton Depression Rating Scales (SIGH-D). SIGH-D is a 29-item clinical interview that expands the 21-item Hamilton Depression Rating Scale for Depression (HAM-D) to include eight items assessing "atypical symptoms" of depression. Ranges for individual parameters vary but a score of 0 signifies less severity (e.g., no/absent) and incrementally higher scores represent more severe symptoms. Total SIGH-D scores can range from 0 to 90. A higher overall SIGH-D score denotes increased severity of Depression.