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

Not Applicable

Active, not recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Behavioral: TEACH

• Registration Number: NCT04335643
• Lead Sponsor: Michigan State University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-06
• Study Start: 2020-08-04
• Primary Completion: 2023-03-22
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-25
• Last Update Posted: 2023-05-26
• Study Completion: 2024-08-24

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 65

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEACH	TEACH	Participants will undergo CBT and continue medical TAU.

Primary Outcome Measures

Name	Time	Method
Retention rates of the study	After data collection period, approximately 2 years	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.
Recruitment rates of the study	After enrollment period, approximately 2 years	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.
Feasibility of remotely-delivered TEACH	Approximately 8 weeks	Feasibility will be measured by participant feedback in a qualitative interview.

Secondary Outcome Measures

Name	Time	Method
Long-term changes in fatigue, as measured by the PROMIS Fatigue SF	Between 20 and 32 weeks, and 12-27 from post-assessment	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.
Changes in fatigue, as measured by the PROMIS Fatigue SF	Approximately 8 weeks	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.
Changes in depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II)	Approximately 8 weeks	The CDI-2 measures depressive symptoms on a scale of 0-54, with 0 indicating low levels of depressive symptoms, and 54 indicating high levels of depressive symptoms. The BDI-II measures depressive symptoms on a scale of 0 to 63, with 0 indicating low levels of depressive symptoms and 63 indicating high levels of depressive symptoms.
Long-term changes in depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II)	Between 20 and 32 weeks, and 12-27 from post-assessment	The CDI-2 measures depressive symptoms on a scale of 0-54, with 0 indicating low levels of depressive symptoms, and 54 indicating high levels of depressive symptoms. The BDI-II measures depressive symptoms on a scale of 0 to 63, with 0 indicating low levels of depressive symptoms and 63 indicating high levels of depressive symptoms.

Trial Locations

Locations (2)

Michigan State University; 🇺🇸 Grand Rapids, Michigan, United States

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada