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

NCT04335643 | Completed

• 1 other identifier: STUDY00003882
• Study Type: interventional
• Target: 65
• Locations: 2 countries
• Sites: 2

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.

Conditions

Systemic Lupus Erythematosus

Keywords

lupus; depression; depressive symptoms; fatigue; pain; SLE; rheumatic disease; rheumatology; telehealth; CBT

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Changes in fatigue, as measured by the PROMIS Fatigue SF

  Approximately 4 weeks

• Changes in fatigue, as measured by the PROMIS Fatigue SF

  Approximately 8 weeks

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

  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)

  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)

  Approximately 8 weeks

Other Outcomes (26)

• Changes in pain, as measured by the Pain Visual Analog Scale (VAS)

  Approximately 4 weeks

• Changes in pain, as measured by the Pain Visual Analog Scale (VAS)

  Approximately 8 weeks

• Long-term changes in pain, as measured by the Pain Visual Analog Scale (VAS)

  Between 20 and 32 weeks, and between 12-27 months from post-assessment

Study Arms (2)

TEACH

EXPERIMENTAL

Participants will undergo CBT and continue medical TAU.

Behavioral: TEACH

Control

NO INTERVENTION

Participants will only continue medical TAU.

Interventions

TEACH BEHAVIORAL

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

Also known as: Treatment and Education Approach for Childhood-onset Lupus

TEACH

Eligibility Criteria

• Age: 12 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michigan State University: lead
• Arthritis Foundation: collaborator
• The Hospital for Sick Children: collaborator

Study Sites (2)

Michigan State University

Grand Rapids, Michigan, 49503, United States

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• Cunningham NR, Miller A, Ely SL, Reid MR, Danguecan A, Mossad SI, Pereira LF, Abulaban K, Kessler E, Rosenwasser N, Nanda K, Rubinstein T, Reeves M, Kohut SA, Stinson J, Tal TE, Levy DM, Hiraki L, Smitherman EA, Knight AM. A multi-site pilot randomized clinical trial of the Treatment and Education Approach for Childhood-onset Lupus (TEACH) program: study design and COVID-19 adaptations. Pediatr Rheumatol Online J. 2023 Jun 23;21(1):61. doi: 10.1186/s12969-023-00835-6.

  PMID: 37353795 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Depression; Fatigue; Pain; Rheumatic Diseases

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Musculoskeletal Diseases

Study Officials

• Natoshia Cunningham, PhD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will either be randomly assigned to the intervention or to a wait-list period.

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: April 6, 2020
• Study Start: August 4, 2020
• Primary Completion: March 22, 2023
• Study Completion: October 16, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

US (1); CA (1)