NCT04335643Completed
Telehealth CBT for Adolescents and Young Adults With Childhood-onset Systemic Lupus Erythematosus
A Remotely Delivered CBT Intervention for Youth With cSLE: A Multi-site Patient-engaged Investigation
Source: ClinicalTrials.gov · Last updated 13 Feb 2025
Brief summary (registry, in English)
This study aims to investigate the feasibility and effectiveness of a remotely delivered psychological intervention for youth with cSLE. This intervention aims to teach participants skills in order to cope with fatigue, pain, and depressive symptoms--symptoms that commonly affect adolescents and young adults with lupus.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 65 (actual)
- First submitted
- 27 Feb 2020
- Start date
- 4 Aug 2020
- Primary completion date
- 22 Mar 2023
- Lead sponsor
- Michigan State University
- Diseases
- Lupus (SLE)
- NCT number
- NCT04335643
What you commit to
- Study type: Interventional
- Participants enrolled: 65
- From 4 Aug 2020 to the primary completion date, 22 Mar 2023
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients currently receiving psychological treatment for depression, fatigue or pain will be excluded to prevent overlapping treatments that may confound outcomes.
Other illness
- Patients with other chronic medical conditions (e.g., juvenile arthritis),
- Patients with a documented developmental delay, severe cognitive impairment, or thought disorder
- Patients with an untreated major psychiatric illness (e.g., bipolar disorder, psychosis, severe depression, or active suicidal ideation)
Who the study is looking for
- Participants must be diagnosed with cSLE, meeting the revised American College of Rheumatology Classification Criteria for SLE by age 18 years
- Participants must have at least one elevation (based off of screening measures) in fatigue, or depressive symptoms, or pain
- Patient participants must have English language proficiency
- For participants under age 18, must have a primary caregiver willing to participate.
Age in the registry: 12 years to 22 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Michigan State University Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.