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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Diabetes Distress Scale

Glycosylated Hemoglobin (HbA1c)

Secondary outcome measures

Diabetes Support and Isolation Questionnaire

Generalized Anxiety Disorder Assessment

Hypoglycemic Attitudes and Behaviors Scale

+5 more

Other outcome measures

Acceptance and Action Diabetes Questionnaire

Body Mass Index (BMI)

Cost-effectiveness

+1 more

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

Find a Location

Who is running the clinical trial?

Scripps Whittier Diabetes InstituteLead Sponsor

17 Previous Clinical Trials

5,139 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,358 Previous Clinical Trials

4,315,145 Total Patients Enrolled

Athena Philis-Tsimikas, MDPrincipal InvestigatorScripps Whittier Diabetes Institute

13 Previous Clinical Trials

4,409 Total Patients Enrolled

Media Library

ACT1VATE Clinical Trial Eligibility Overview. Trial Name: NCT04933851 — Phase 2

Type 1 Diabetes Research Study Groups: ACT1VATE, DSME/S (usual care)

Type 1 Diabetes Clinical Trial 2023: ACT1VATE Highlights & Side Effects. Trial Name: NCT04933851 — Phase 2

ACT1VATE 2023 Treatment Timeline for Medical Study. Trial Name: NCT04933851 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How reliable is ACT1VATE in terms of protecting people's health?

"The safety of ACT1VATE was appraised at a 2, as the evidence base for its efficacy is currently lacking but there are some findings that suggest it is safe."

Answered by AI

What is the primary goal of this medical research?

"This trial will be monitored across a Baseline, 6-month and 12-month timeline with the goal of assessing Glycosylated Hemoglobin (HbA1c). Secondary objectives include evaluating participants' response to hypoglycemia via Hypoglycemic Attitudes and Behaviors Scale [HABS], knowledge regarding diabetes through Revised Diabetes Knowledge Test, and general stress levels using Perceived Stress Scale (PSS-4). Multilevel models built on full information maximum likelihood estimation will compare post-intervention data against baseline scores in order to detect any group by time interactions. If an interaction is found significant, additional analyses may"

Answered by AI

Are there still opportunities for participants to join this experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, this study began recruiting participants as of October 25th 2021 and is still open for enrolment today. Additionally, 484 patients are wanted from 1 trial site."

Answered by AI

How many individuals are participating in this clinical experiment?

"Affirmative, the clinicaltrials.gov database confirms that this experiment is recruiting participants as of now. This research project was first posted on October 25th 2021 and has been recently updated on July 5th 2022; 484 patients are needed from 1 medical facility to complete the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Athena Philis-Tsimikas 2021. "ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04933851.