Coping Skills Program for Lupus

(cSLE Trial)

Recruiting at 7 trial locations

Overseen By Jocelyn S Zuckerman, BA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Michigan State University

Disqualifiers: Juvenile arthritis, Developmental delay, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 8 weeks

175 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program to help young people with lupus manage symptoms like fatigue, pain, and depression. Participants will either join a cognitive behavioral program called TEACH (Treatment and Education Approach for Childhood-onset Lupus), which focuses on building coping skills, or continue with their usual medical treatment. It suits those aged 12 to 22 diagnosed with childhood-onset lupus who experience significant fatigue, pain, or depressive symptoms. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in managing lupus symptoms.

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 prior data suggests that this program is safe for youth with lupus?

Research has shown that the TEACH program, which helps young people with lupus develop coping skills, has been tested in earlier studies. These studies examined participants' ability to handle the program and its effects. Results suggest that young people generally manage the program well, with no reports of negative side effects directly linked to it.

The program does not involve medication, so risks are typically lower compared to drug treatments. Instead, it focuses on teaching skills to manage symptoms like tiredness, pain, and depression, making it a safe option for many participants. While specific data on negative effects is lacking, the nature of the TEACH program and its past testing suggest it is a safe and beneficial addition to regular medical care for young people with lupus. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TEACH program because it offers a new approach by integrating cognitive behavioral coping skills specifically for lupus patients. Unlike standard treatments for lupus, which mainly focus on managing symptoms with medications like corticosteroids and immunosuppressants, TEACH aims to equip patients with mental tools to better handle the psychological and emotional challenges of the disease. This holistic approach could potentially enhance overall well-being and improve quality of life, making it a promising addition to existing medical treatments.

What evidence suggests that the TEACH program is effective for coping with lupus symptoms?

Research has shown that the TEACH program, which uses talk therapy and mindfulness techniques, can help young people with childhood-onset lupus manage their symptoms. Participants in this trial will undergo the TEACH program as part of the experimental arm. Past participants reported feeling better able to cope with fatigue, pain, and depression, which are common with lupus. Studies have found that the program is easy to follow and participants found it helpful. Early results suggest that TEACH might effectively reduce tiredness and improve mood. Overall, these findings provide promising evidence that TEACH could support young people with lupus. ^{1 2 3 6 7}

Who Is on the Research Team?

Natoshia R Cunningham, PhD

Principal Investigator

Michigan State University

Andrea Knight, MD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• TEACH

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Michigan State University

Lead Sponsor

Trials

202

Recruited

687,000+

Tulane University

Collaborator

Trials

129

Recruited

259,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+

Helen DeVos Children's Hospital

Collaborator

Trials

11

Recruited

7,400+

Montefiore Medical Center

Collaborator

Trials

468

Recruited

599,000+

Published Research Related to This Trial

The TEACH program, a remotely delivered cognitive-behavioral therapy intervention, is being tested for its feasibility and effectiveness in reducing fatigue, depressive symptoms, and pain in adolescents and young adults with childhood-onset Systemic Lupus Erythematosus (cSLE).

This pilot randomized controlled trial involves participants aged 12-22 years from six rheumatology clinics and aims to compare the effects of TEACH combined with standard medical treatment against standard treatment alone, potentially improving clinical care for cSLE patients.

NCBI (Pubmed)

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. Cunningham, NR., Miller, A., Ely, SL., et al.[2023]

Management of childhood-onset systemic lupus erythematosus (cSLE) requires a comprehensive approach that includes validated classification criteria and assessments of disease impact on quality of life, as well as monitoring for specific biomarkers related to lupus nephritis.

Treatment for cSLE involves supportive care and immunosuppressive therapy, with important considerations for patient safety regarding infections, vaccinations, and long-term health outcomes such as bone health and organ damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management considerations for childhood-onset systemic lupus erythematosus patients and implications on therapy. Silva, CA., Aikawa, NE., Pereira, RM., et al.[2016]

In a study of 124 systemic lupus erythematosus patients, many reported insufficient information about their diagnosis, highlighting a need for better education to improve understanding and management of the disease.

The study found high levels of anxiety (67%) and significant fatigue (average score of 66mm) among patients, indicating that emotional and physical symptoms greatly affect their quality of life and should be addressed in therapeutic education programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exploring illness perceptions of lupus patients for a motivational environment in therapeutic education]. Farhat, MM., Condette-Wojtasik, G., Maillard, H., et al.[2020]

A pilot study involving 83 participants with systemic lupus erythematosus (SLE) tested a web-based Acceptance and Commitment Therapy (ACT) program, which was found to be feasible and well-accepted, with high usability ratings.

Participants reported positive experiences with the ACT for Lupus program, suggesting it effectively supports their mental well-being during the COVID-19 pandemic, although they recommended enhancements for content and flexibility.

NCBI (Pubmed)

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. McCormick, EM., Englund, TR., Cleveland, RJ., et al.[2022]

Children with childhood-onset systemic lupus erythematosus (cSLE) showed lower academic competence ratings compared to healthy peers, despite having similar neurocognitive functioning, indicating that cSLE may impact academic performance beyond cognitive abilities.

The study found that academic outcomes in cSLE were correlated with disease activity and treatment intensity, suggesting that managing these factors could help improve educational achievements in affected children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Academic outcomes in childhood-onset systemic lupus erythematosus. Zelko, F., Beebe, D., Baker, A., et al.[2023]

In a feasibility trial involving 53 female adolescents with systemic lupus erythematosus, a cognitive-behavioral intervention did not show significant differences in pain management or quality of life compared to education-only and no-contact control groups.

However, participants in the cognitive-behavioral group reported improved coping skills post-intervention, suggesting that while the primary outcomes were not met, there may be potential benefits in coping that warrant further investigation in larger studies.

NCBI (Pubmed)

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. Brown, RT., Shaftman, SR., Tilley, BC., et al.[2021]

Young women with childhood-onset systemic lupus erythematosus reported various coping strategies during their transition from pediatric to adult healthcare, including problem-focused coping and adaptive emotion-focused coping, which can positively influence their psychosocial health.

The study highlights that emotional responses to this transition, such as fear and empowerment, are important to consider, as effective coping mechanisms can significantly impact the success of transferring to adult care.

NCBI (Pubmed)

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. Bitencourt, N., Ciosek, A., Kramer, J., et al.[2022]

The TEACH protocol, a 6-session cognitive behavioral therapy intervention for adolescents and young adults with childhood-onset systemic lupus erythematosus, was found to be feasible and acceptable, with significant reductions in fatigue and depressive symptoms after the intervention.

In a small study of 14 participants aged 13-19, the TEACH protocol demonstrated potential effectiveness in managing symptoms of cSLE, suggesting it could be a valuable tool for improving the quality of life in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and pilot testing of the treatment and education approach for childhood-onset lupus (TEACH): a cognitive behavioral treatment. Cunningham, NR., Fussner, LM., Moorman, E., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37353795/

A multi-site pilot randomized clinical trial of the Treatment ... This two-arm multisite RCT will explore the feasibility (primary outcome) and effect (secondary outcome) of a remotely delivered TEACH protocol.

2. ped-rheum.biomedcentral.com ped-rheum.biomedcentral.com/articles/10.1186/s12969-023-00835-6

A multi-site pilot randomized clinical trial of the Treatment and ... Our research team developed the Treatment and Education Approach for Childhood-Onset Lupus (TEACH), a tailored CBT for youth with cSLE targeting ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30777090/

a cognitive behavioral treatment - PubMed - NIH Results suggest that TEACH is feasible, acceptable, and potentially effective in the management of cSLE symptoms. Following the intervention, ...

4. trials.arthritis.org trials.arthritis.org/trials/NCT06232304

Transforming Care for Individuals With Childhood-onset Systemic ... This TEACH program aims to teach participants skills in order to cope with fatigue, pain, and depressive symptoms--symptoms that commonly affect adolescents and ...

5. healio.com healio.com/news/rheumatology/20230919/teach-program-combines-therapymeditation-and-education-for-young-patients-with-lupusto-manage-fatigu

TEACH combines meditation, education to manage fatigue ... A program using cognitive behavioral and mindfulness meditation techniques demonstrated early potential to ease fatigue, depression and pain ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04335643

Telehealth CBT for Adolescents and Young Adults With ... This study aims to investigate the feasibility and effectiveness of a remotely delivered psychological intervention for youth with cSLE.

7. springermedizin.de springermedizin.de/a-multi-site-pilot-randomized-clinical-trial-of-the-treatment-an/25530484

A multi-site pilot randomized clinical trial of the Treatment and ... This pilot randomized controlled trial (RCT) aims to determine the feasibility and effect of TEACH for youth with cSLE. Adjustments to the study protocol ...