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Psychological Intervention for Type 1 Diabetes

Phase 2

Recruiting

Led By Athena Philis-Tsimikas, MD

Research Sponsored by Scripps Whittier Diabetes Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months, 9 months, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare a psychological intervention against diabetes self-management education and support to see which improves clinical, behavioral, psychosocial, process, and cost outcomes among adults with poorly controlled type 1 diabetes who are experiencing significant diabetes-related emotional distress.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since ACT1VATE is a psychological intervention rather than a medication, it may not have typical drug side effects. However, participants might experience emotional discomfort when discussing distressing topics during therapy sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months, 9 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months, 9 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 9 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Diabetes Distress Scale

Glycosylated Hemoglobin (HbA1c)

Secondary study objectives

Diabetes Support and Isolation Questionnaire

Generalized Anxiety Disorder Assessment

Hypoglycemic Attitudes and Behaviors Scale

+5 more

Other study objectives

Acceptance and Action Diabetes Questionnaire

Body Mass Index (BMI)

Cost-effectiveness

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

Do I qualify?Apply below to find out