Coping Skills Program for Lupus

(cSLE Trial)

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen by Natoshia R Cunningham, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Michigan State University

Disqualifiers: Juvenile arthritis, Developmental delay, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This study aims to investigate the feasibility and effectiveness of a cognitive behavioral coping skills program, Treatment and Education Approach for Childhood-onset Lupus (TEACH), for youth with cSLE when integrated into medical care. This TEACH program 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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a coping skills program for lupus, so it's best to discuss your medications with the trial coordinators.

What data supports the effectiveness of the treatment TEACH for childhood-onset lupus?

The TEACH program, which uses cognitive behavioral therapy (CBT), has shown potential in helping young people with childhood-onset lupus manage symptoms like fatigue, mood issues, and pain. Similar CBT interventions have been effective in improving quality of life and helping patients adjust to living with lupus.

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Is the Coping Skills Program for Lupus safe for humans?

The TEACH program, a cognitive behavioral therapy for childhood-onset lupus, has been tested for feasibility and initial effectiveness, indicating it is generally safe for use in humans.

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How is the TEACH treatment different from other treatments for childhood-onset lupus?

The TEACH treatment is unique because it uses cognitive behavioral therapy (CBT), a psychological approach, to help adolescents and young adults with childhood-onset lupus manage symptoms like fatigue, mood issues, and pain, which are not typically addressed by standard medical treatments.

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Eligibility Criteria

This trial is for young individuals aged 12-22 with childhood-onset Systemic Lupus Erythematosus (cSLE). They must meet specific criteria by age 18, experience fatigue, depression, or pain related to cSLE and be proficient in English. A consenting caregiver is required for participants under the legal adult age.

Inclusion Criteria

I was diagnosed with lupus (SLE) before I turned 18.

I am between 12 and 22 years old.

I am under the age limit and have a caregiver who can consent for me.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a cognitive behavioral coping skills program (TEACH) integrated into their medical care

8 weeks

6 sessions (in-person or remote)

Follow-up

Participants are monitored for psychological and disease-related outcomes over time

56 weeks

Regular assessments at 8, 20, 32, 44, and 56 weeks

Implementation and Maintenance

Evaluation of TEACH implementation success and maintenance of program use

April 2023 to October 2027

Participant Groups

The study tests a program called TEACH (Treatment and Education Approach for Childhood-onset Lupus), which teaches coping skills to manage symptoms like fatigue, pain, and depressive symptoms that affect adolescents and young adults with lupus.

Group I: TEACH Experimental Treatment 1 Intervention

Participants will undergo a cognitive behavioral coping skills program and continue medical treatment as usual.

Group II: Control Active Control 1 Intervention

Participants will only continue medical treatment as usual.

TEACH is already approved in United States for the following indications:

🇺🇸 Approved in United States as TEACH for:

• Childhood-onset Systemic Lupus Erythematosus (cSLE) symptoms management, specifically fatigue, pain, and depressive symptoms

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Alabama Birmingham Hospital Birmingham, AL

Children's Hospital of New Orleans/ Tulane University New Orleans, LA

Montefiore Medical Center Bronx, NY

Cincinnati Children's Hospital Medical Center Cincinnati, OH

More Trial Locations

Who Is Running the Clinical Trial?

Michigan State University Lead Sponsor

Tulane University Collaborator

University of Alabama at Birmingham Collaborator

Children's Hospital Medical Center, Cincinnati Collaborator

United States Department of Defense Collaborator

The Hospital for Sick Children Collaborator

Seattle Children's Hospital Collaborator

Helen DeVos Children's Hospital Collaborator

Montefiore Medical Center Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Development and pilot testing of the treatment and education approach for childhood-onset lupus (TEACH): a cognitive behavioral treatment. [2023] To develop and test the feasibility and initial effectiveness of the Treatment and Education Approach for Childhood-onset Lupus (TEACH) protocol, a 6-session cognitive behavioral therapy (CBT) intervention for adolescents and young adults (AYA) with childhood-onset systemic lupus erythematosus (cSLE).

2. England pubmed.ncbi.nlm.nih.gov

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. [2023] Childhood-onset Systemic Lupus Erythematosus (cSLE) is an autoimmune disease associated with fatigue, mood symptoms, and pain. Fortunately, these symptoms are potentially modifiable with psychological intervention such as cognitive-behavioral therapy (CBT). The Treatment and Education Approach for Childhood-onset Lupus (TEACH) program is a CBT intervention developed to target these symptoms for adolescents and young adults with cSLE. This pilot randomized controlled trial (RCT) aims to determine the feasibility and effect of TEACH for youth with cSLE. Adjustments to the study protocol following the COVID-19 pandemic are also described.

3. United States pubmed.ncbi.nlm.nih.gov

The health education for lupus study: a randomized controlled cognitive-behavioral intervention targeting psychosocial adjustment and quality of life in adolescent females with systemic lupus erythematosus. [2021] To examine in a randomize controlled feasibility clinical trial the efficacy of a cognitive-behavioral intervention designed to manage pain, enhance disease adjustment and adaptation and improve quality of life among female adolescents with systemic lupus erythematosus.

4. United States pubmed.ncbi.nlm.nih.gov

ACT for Lupus: Pilot Feasibility and Acceptability Study of a Novel Web-Based Acceptance and Commitment Therapy Program for Patients With Lupus. [2022] Acceptance and commitment therapy (ACT) has demonstrated effectiveness in addressing symptoms of anxiety and depression, frequently experienced by patients with systemic lupus erythematosus (SLE). The goal of this pilot study was to develop and assess the feasibility and acceptability of a novel web-based ACT skills training program tailored for patients with lupus: ACT for Lupus. The program served as a complementary approach to support the management of symptoms and stressors during the COVID-19 pandemic.

5. United States pubmed.ncbi.nlm.nih.gov

Academic outcomes in childhood-onset systemic lupus erythematosus. [2023] To explore academic outcomes in childhood-onset systemic lupus erythematosus (cSLE) and their relationship to variables such as demographic and socioeconomic status, neurocognitive functioning, behavioral/emotional adjustment, and cSLE disease status.

6. France pubmed.ncbi.nlm.nih.gov

[Exploring illness perceptions of lupus patients for a motivational environment in therapeutic education]. [2020] Therapeutic education (TE) intends to help patients with systemic lupus erythematosus to better understand their disease and to improve their quality of life. The objective of this study was to assess illness perceptions of the person to provide a motivational environment for TE.

7. England pubmed.ncbi.nlm.nih.gov

Management considerations for childhood-onset systemic lupus erythematosus patients and implications on therapy. [2016] Childhood-onset systemic lupus erythematosus (cSLE) is a chronic inflammatory and autoimmune disease that may involve various organs and systems. This narrative review focuses on the recent evidence relating to cSLE management. The general management considerations of cSLE patients require the use of validated classification criteria, disease and health-related quality of life tools evaluation, as well as assessments of lupus nephritis biomarkers and cSLE quality indicators. The drug treatment for cSLE patients includes general supportive care and immunosuppressive therapy. Important implications on cSLE therapy are also updated such as infection, vaccination, infertility, pregnancy, contraception, dyslipidemia, physical activity, cancer, bone health, drug pharmacokinetics, adherence, academic outcomes, transition to adult care and cumulative organ damage.

8. England pubmed.ncbi.nlm.nih.gov

"You Just Have to Keep Going, You Can't Give Up": Coping mechanisms among young adults with lupus transferring to adult care. [2022] Coping mechanisms and emotional regulation are important contributors to psychosocial health during stressful life events. We sought to describe the coping and emotional responses of persons with childhood-onset systemic lupus erythematosus during the transfer from pediatric to adult healthcare.