Psychological Intervention for Type 1 Diabetes
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Scripps Whittier Diabetes Institute
No Placebo Group
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?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.
Is the treatment ACT1VATE a promising treatment for type 1 diabetes?Yes, ACT1VATE is a promising treatment for type 1 diabetes because it helps reduce diabetes distress, which is linked to better diabetes management and improved blood sugar control over time.23567
What safety data exists for psychological interventions in type 1 diabetes?The provided research does not directly address safety data for psychological interventions in type 1 diabetes. However, it suggests that these interventions, such as those targeting diabetes distress, are associated with improved glycemic outcomes and reduced distress. This implies a positive impact on diabetes management, but specific safety data is not detailed in the abstracts.13457
What data supports the idea that Psychological Intervention for Type 1 Diabetes is an effective treatment?The available research shows that psychological interventions can effectively reduce diabetes distress, which is the emotional burden of managing diabetes. For example, the T1-REDEEM study found that these interventions helped lower distress levels and improved blood sugar control in adults with Type 1 diabetes. Another study highlighted that reducing distress through targeted interventions led to better diabetes management and improved blood sugar levels over time. These findings suggest that psychological interventions can be a valuable treatment for managing Type 1 diabetes.13457
Do I need to stop my current medications to join the trial?The trial protocol does not specify whether you need to stop taking your current medications.
Eligibility Criteria
This trial is for adults with Type 1 Diabetes who feel very stressed about their diabetes and have high blood sugar levels (HbA1c ≥ 8% in the last 90 days). They must speak English or Spanish, be a patient at Scripps Health, and plan to stay in San Diego for the next year. People with severe health or mental issues that could affect participation are not eligible.Participant Groups
The study compares 'ACT1VATE', a psychological intervention aimed at reducing stress related to diabetes, against standard diabetes education and support (DSME/S) to see which is better at improving control of blood sugar levels and overall well-being among patients.
2Treatment groups
Experimental Treatment
Active Control
Group I: ACT1VATEExperimental Treatment1 Intervention
Participants assigned to the intervention group will be offered a psychological intervention specifically designed to address diabetes-related emotional distress.
Group II: DSME/S (usual care)Active Control1 Intervention
Participants randomized to the usual care group will be offered standard diabetes self-management education and support (DSME/S).
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Scripps Whittier Diabetes InstituteSan Diego, CA
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Who is running the clinical trial?
Scripps Whittier Diabetes InstituteLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Psychological interventions to improve glycaemic control in patients with type 1 diabetes: systematic review and meta-analysis of randomised controlled trials. [2022]To determine whether psychological interventions have any effect on glycaemic control in people with type 1 diabetes.
Understanding the sources of diabetes distress in adults with type 1 diabetes. [2022]To identify the unique sources of diabetes distress (DD) for adults with type 1 diabetes (T1D).
T1-REDEEM: A Randomized Controlled Trial to Reduce Diabetes Distress Among Adults With Type 1 Diabetes. [2022]To compare the effectiveness of two interventions to reduce diabetes distress (DD) and improve glycemic control among adults with type 1 diabetes (T1D).
There is value in treating elevated levels of diabetes distress: the clinical impact of targeted interventions in adults with Type 1 diabetes. [2022]To compare the effect of targeted interventions to reduce high diabetes distress among adults with Type 1 diabetes with a comparison sample of similar but untreated individuals, and to document the stability of untreated diabetes distress over time.
Reductions in Management Distress Following a Randomized Distress Intervention Are Associated With Improved Diabetes Behavioral and Glycemic Outcomes Over Time. [2022]To explore associations between reductions in diabetes distress (DD) and improvements in glycemic outcomes among adults with type 1 diabetes (T1D) in the context of a DD randomized clinical trial.
Function and Emotion in Everyday Life With Type 1 Diabetes (FEEL-T1D): Protocol for a Fully Remote Intensive Longitudinal Study. [2023]Although short-term blood glucose levels and variability are thought to underlie diminished function and emotional well-being in people with type 1 diabetes (T1D), these relationships are poorly understood. The Function and Emotion in Everyday Life with T1D (FEEL-T1D) study focuses on investigating these short-term dynamic relationships among blood glucose levels, functional ability, and emotional well-being in adults with T1D.
Validation of the type 1 diabetes distress scale (T1-DDS) in a large Danish cohort: Content validation and psychometric properties. [2023]To validate the Type 1 Diabetes Distress Scale (T1-DDS) in a large sample of adults with Type 1 diabetes (T1D) from diabetes clinics in Denmark.