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

Last updated: February 12, 2025
Sponsor: Michigan State University
Overall Status: Completed

Phase

N/A

Condition

Cutaneous Lupus Erythematosus

Systemic Lupus Erythematosus

Lupus

Treatment

TEACH

Clinical Study ID

NCT04335643
STUDY00003882
  • Ages 12-22
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • Participants must have at least one elevation (based off of screening measures) infatigue, 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.

Exclusion

Exclusion Criteria:

  • Patients with other chronic medical conditions (e.g., juvenile arthritis),

  • Patients with a documented developmental delay, severe cognitive impairment, orthought disorder

  • Patients with an untreated major psychiatric illness (e.g., bipolar disorder,psychosis, severe depression, or active suicidal ideation)

  • Patients currently receiving psychological treatment for depression, fatigue or painwill be excluded to prevent overlapping treatments that may confound outcomes.

Study Design

Total Participants: 65
Treatment Group(s): 1
Primary Treatment: TEACH
Phase:
Study Start date:
August 04, 2020
Estimated Completion Date:
October 16, 2024

Study Description

This project is investigating whether a remotely delivered psychological intervention is acceptable and beneficial to teens and young adults coping with cSLE. This study uses a cognitive behavioral therapy (CBT) intervention called the Treatment and Education Approach for Childhood-onset Lupus (TEACH) to address symptoms of fatigue, depression, and pain that commonly occur in individuals with cSLE. The TEACH program includes six-weekly, one hour sessions, conducted over HIPAA-compliant video conferencing.

Participation in this study will take approximately 8-15 weeks, with a follow-up survey occurring 3-months after post-assessment, and a long-term follow-up survey occurring between 12-27 months after post-assessment. After qualifying for the study, participants will be randomly selected, like flipping a coin, to the TEACH program plus medical treatment as usual (TAU) OR medical TAU alone for six weeks. After this six-week time period, a post-assessment will be completed. Participants that only continued medical TAU will then be eligible to receive TEACH after completing the post-assessment. If these participants choose to undergo the TEACH treatment, they will be asked to complete a short interview about the program and answer questions about how their mood, pain, and fatigue.

Connect with a study center

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • Michigan State University

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

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