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

Michigan State University65 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Systemic Lupus Erythematosus

Interventions

TEACHBEHAVIORAL

TEACH is a remotely delivered psychological intervention. It consists of six one-hour weekly sessions that are HIPAA compliant and conducted over video conferencing.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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) * Patients currently receiving psychological treatment for depression, fatigue or pain will be excluded to prevent overlapping treatments that may confound outcomes.

Locations (2)

Michigan State University

Grand Rapids, Michigan, United States

The Hospital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Recruitment rates of the study

Recruitment rates will be measured by the number of participants who agree to participate in the study. This information will be collected after the enrollment period.

Time frame: After enrollment period, approximately 2 years

Retention rates of the study

Retention rates will be measured by the number of participants who complete the study. This information will be collected after the data collection period ends.

Time frame: After data collection period, approximately 2 years

Feasibility of remotely-delivered TEACH

Feasibility will be measured by participant feedback in a qualitative interview.

Time frame: Approximately 8 weeks

Secondary Outcomes

Changes in fatigue, as measured by the PROMIS Fatigue SF

The adult PROMIS Fatigue SF measures fatigue one a scale of 10-40; 10 indicating no fatigue, 40 indicating high levels of fatigue. The pediatric PROMIS Fatigue SF measures on a scale of 0-40; 0 indicating no fatigue and 40 indicating high levels of fatigue. This is to assess changes at a midpoint in the study.

Time frame: Approximately 4 weeks

Changes in fatigue, as measured by the PROMIS Fatigue SF

Time frame: Approximately 8 weeks

Long-term changes in fatigue, as measured by the PROMIS Fatigue SF

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.