← Back to Search

Behavioral Intervention

Telehealth CBT for Lupus (cSLE Trial)

N/A

Waitlist Available

Led By Natoshia Cunningham, PhD

Research Sponsored by Michigan State University

Eligibility Criteria Checklist

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

Must have

For participants under age 18, must have a primary caregiver willing to participate

Participants must be diagnosed with cSLE, meeting the revised American College of Rheumatology Classification Criteria for SLE by age 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after enrollment period, approximately 2 years

Awards & highlights

cSLE Trial Summary

This trial will study whether a remotely-delivered psychological intervention can help adolescents and young adults with lupus manage fatigue, pain, and depressive symptoms.

Who is the study for?

This trial is for young people diagnosed with childhood-onset Systemic Lupus Erythematosus (cSLE) by age 18, who are struggling with fatigue, pain, or depression. They must understand English and if under 18, have a caregiver willing to join the study.Check my eligibility

What is being tested?

The TEACH program is being tested in this study. It's a telehealth Cognitive Behavioral Therapy (CBT) aimed at helping these young individuals manage symptoms like fatigue, pain, and depressive feelings through remote sessions.See study design

What are the potential side effects?

Since this intervention involves psychological therapy rather than medication, traditional side effects are not expected. Participants may experience emotional discomfort addressing personal issues during therapy.

cSLE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am under 18 and have a caregiver willing to participate.

Select...

I was diagnosed with lupus (SLE) before I turned 18.

cSLE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after enrollment period, approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after enrollment period, approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and after enrollment period, approximately 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Feasibility of remotely-delivered TEACH

Recruitment rates of the study

Retention rates of the study

Secondary outcome measures

Changes in depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II)

Changes in fatigue, as measured by the PROMIS Fatigue SF

Long-term changes in depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II)

+1 more

Other outcome measures

Changes in COVID-related distress as measured by a Visual Analog Scale (VAS)

Changes in anxiety, as measured by the Screen for Child Anxiety Related Disorders (SCARED) and Screen for Adult Anxiety Related Disorders (SCAARED)

Changes in caregivers' depression, anxiety, and stress as measured by the Depression Anxiety and Stress Scales 21 (DASS21)

+22 more

cSLE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TEACHExperimental Treatment1 Intervention

Participants will undergo CBT and continue medical TAU.

Group II: ControlActive Control1 Intervention

Participants will only continue medical TAU.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Michigan State UniversityLead Sponsor

184 Previous Clinical Trials

601,342 Total Patients Enrolled

Arthritis FoundationOTHER

34 Previous Clinical Trials

46,086 Total Patients Enrolled

The Hospital for Sick ChildrenOTHER

686 Previous Clinical Trials

6,944,728 Total Patients Enrolled

Media Library

TEACH (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04335643 — N/A

Lupus Research Study Groups: TEACH, Control

Lupus Clinical Trial 2023: TEACH Highlights & Side Effects. Trial Name: NCT04335643 — N/A

TEACH (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04335643 — N/A

Frequently Asked Questions

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

What are the eligibility requirements for participating in this experiment?

"To be eligible for this research, individuals must possess libman-sacks disease and meet the age range of 12 to 22 years. The total number of people accepted into the trial is 75."

Answered by AI

What is the uppermost limit of enrollees in this clinical trial?

"Affirmative. Records on clinicaltrials.gov show that this research project, first posted on August 4th 2020, is currently recruiting patients. 75 participants are being sought at 2 separate sites of study."

Answered by AI

Are there any unoccupied slots remaining in this medical experiment?

"As detailed on clinicaltrials.gov, the trial is actively seeking participants and has been since August 4th 2020 with a recent update being made on 28 November 2022."

Answered by AI

What is the ultimate aim of this trial?

"The aims of this 8-week research are to evaluate recruitment rates and changes in depressive symptoms, fatigue, and long-term alterations in depression. This will be ascertained by the CDI-2 (scale 0–54) and BDI-II (scale 0–63) for measuring depressive symptoms; PROMIS Fatigue SF with adult scale 10–40 or pediatric scale 0–40 for assessing fatigue levels."

Answered by AI

Does this clinical trial encompass individuals over the age of fifty-five?

"The screening process for this trial only encompasses participants between the ages of 12 and 22. However, there are other studies available to those younger than 18 years old as well as individuals over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Telehealth CBT for Adolescents and Young Adults With Childhood-onset Systemic Lupus Erythematosus

Natoshia Cunningham 2020. "Telehealth CBT for Adolescents and Young Adults With Childhood-onset Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04335643.

All > Systemic Lupus Erythematosus > Lupus