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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
Must not have
Patients currently receiving psychological treatment for depression, fatigue, or pain will be excluded to prevent overlapping treatments that may confound outcomes
Patients with an untreated major psychiatric illness (e.g., bipolar disorder, psychosis, severe depression, or active suicidal ideation)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after enrollment period, approximately 2 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am under 18 and have a caregiver willing to participate.
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I was diagnosed with lupus (SLE) before I turned 18.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not currently receiving psychological treatment for depression, fatigue, or pain.
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I do not have an untreated major psychiatric illness.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of remotely-delivered TEACH
Recruitment rates of the study
Retention rates of the study
Secondary study objectives
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 study objectives
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

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: TEACHExperimental Treatment1 Intervention
Participants will undergo CBT and continue medical TAU.
Group II: ControlActive Control1 Intervention
Participants will only continue medical TAU.

Find a Location

Who is running the clinical trial?

Michigan State UniversityLead Sponsor
198 Previous Clinical Trials
685,669 Total Patients Enrolled
Arthritis FoundationOTHER
35 Previous Clinical Trials
46,416 Total Patients Enrolled
The Hospital for Sick ChildrenOTHER
711 Previous Clinical Trials
6,958,215 Total Patients Enrolled
Natoshia Cunningham, PhDPrincipal Investigator - Michigan State University
Michigan State University
2 Previous Clinical Trials
188 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
~12 spots leftby Dec 2025
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