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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Remotely Delivered CBT Intervention for Youth With cSLE: A Multi-site Patient-engaged Investigation

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Behavioral: TEACH


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will either be randomly assigned to the intervention or to a wait-list period.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEACH<br>Participants will undergo CBT and continue medical TAU. | Behavioral: TEACH<br>* TEACH is a remotely delivered psychological intervention. It consists of six one-hour weekly sessions that are HIPAA compliant and conducted over video conferencing.<br>* Other names: Treatment and Education Approach for Childhood-onset Lupus;|
| No Intervention: Control<br>Participants will only continue medical TAU. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | After data collection period, approximately 2 years | 
| Feasibility of remotely-delivered TEACH | Feasibility will be measured by participant feedback in a qualitative interview. | Approximately 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Approximately 4 weeks | 
| 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. | Approximately 8 weeks | 
| Long-term 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. | Between 20 and 32 weeks, and 12-27 from post-assessment | 
| Changes in depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II) | 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. This is to assess changes at a midpoint in the study. | Approximately 4 weeks | 
| Changes in depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II) | 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. | Approximately 8 weeks | 
| Long-term changes in depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II) | 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. | Between 20 and 32 weeks, and 12-27 from post-assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lupus, depression, depressive symptoms, fatigue, pain, SLE, rheumatic disease, rheumatology, telehealth, CBT