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

Michigan State University

Status

Completed

Conditions

Systemic Lupus Erythematosus

Treatments

Behavioral: TEACH

Study type

Interventional

Funder types

Other

Identifiers

NCT04335643

STUDY00003882

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 patients

Sex

All

Ages

12 to 22 years old

Volunteers

No Healthy Volunteers

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.