Coping Skills Program for Lupus

(cSLE Trial)

Recruiting at 6 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

196 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

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. ^{1 2 3 4 8}

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.

Research Team

Natoshia R Cunningham, PhD

Principal Investigator

Michigan State University

Andrea Knight, MD

Principal Investigator

The Hospital for Sick Children

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.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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

Academic outcomes in childhood-onset systemic lupus erythematosus. [2023]

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

[Exploring illness perceptions of lupus patients for a motivational environment in therapeutic education]. [2020]

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

Management considerations for childhood-onset systemic lupus erythematosus patients and implications on therapy. [2016]

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]