Systemic Lupus ErythematosuscSLENCT04335643
Telehealth CBT for Adolescents and Young Adults With Childhood-onset Systemic Lupus Erythematosus
A study testing TEACH in people with Systemic Lupus Erythematosus, run by Michigan State University at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 22 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- TEACH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 4 Aug 2020to 16 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Michigan State University
Grand Rapids, Michigan, 49503
About this study
Official title: A Remotely Delivered CBT Intervention for Youth With cSLE: A Multi-site Patient-engaged Investigation
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.
Read the detailed description
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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- TEACH
- Keywords
- lupus, depression, depressive symptoms, fatigue, pain, SLE, rheumatic disease, rheumatology, telehealth, CBT
- Medical subject headings
- Lupus Erythematosus, Systemic, Depression, Fatigue, Pain, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEACHBehavioural
Also called Treatment and Education Approach for Childhood-onset Lupus
TEACH is a remotely delivered psychological intervention. It consists of six one-hour weekly sessions that are HIPAA compliant and conducted over video conferencing.
| Study group | Role | What they receive |
|---|---|---|
| TEACH | Experimental | Participants will undergo CBT and continue medical TAU. Receives: Behavioral: TEACH |
| Control | No intervention | Participants will only continue medical TAU. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After data collection period, approximately 2 years
Feasibility of remotely-delivered TEACH
Feasibility will be measured by participant feedback in a qualitative interview.
Measured: Approximately 8 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Between 20 and 32 weeks, and 12-27 from post-assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start4 Aug 2020
- Primary completion22 Mar 2023
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will either be randomly assigned to the intervention or to a wait-list period.
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Foundation, The Hospital for Sick Children
- Responsible party
- Principal investigator, Natoshia Cunningham, Michigan State University
- Investigators
- Natoshia Cunningham, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335643
- Sponsor's protocol ID
- STUDY00003882
- Acronym
- cSLE
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2020
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37353795
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Remotely Delivered CBT Intervention for Youth With cSLE: A Multi-site Patient-engaged Investigation
- ClinicalTrials.gov ID
- NCT04335643
- Acronym / sponsor ID
- cSLE / STUDY00003882
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- lupus, depression, depressive symptoms, fatigue, pain, SLE, rheumatic disease, rheumatology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Arthritis Foundation, The Hospital for Sick Children
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will either be randomly assigned to the intervention or to a wait-list period.
| Arm | Type | Receives |
|---|---|---|
| TEACH | Experimental | Behavioral: TEACHParticipants will undergo CBT and continue medical TAU. |
| Control | No intervention | –Participants will only continue medical TAU. |
Who may qualify
- Ages
- 12 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEACHAlso: Treatment and Education Approach for Childhood-onset LupusTEACH is a remotely delivered psychological intervention. It consists of six one-hour weekly sessions that are HIPAA compliant and conducted over video conferencing. | Behavioural | TEACH |
Primary outcome
Recruitment rates of the study
Time frame: After enrollment period, approximately 2 years
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.
Retention rates of the study
Time frame: After data collection period, approximately 2 years
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.
Feasibility of remotely-delivered TEACH
Time frame: Approximately 8 weeks
Feasibility will be measured by participant feedback in a qualitative interview.
6 secondary outcomes
Changes in fatigue, as measured by the PROMIS Fatigue SF
Time frame: Approximately 4 weeks
Changes in fatigue, as measured by the PROMIS Fatigue SF
Time frame: Approximately 8 weeks
Long-term changes in fatigue, as measured by the PROMIS Fatigue SF
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Between 20 and 32 weeks, and 12-27 from post-assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Derived from this study: PubMed 37353795Cunningham 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.
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natoshia Cunningham, PhD principal investigator
Michigan State University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEACH in people with Systemic Lupus Erythematosus, run by Michigan State University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates of the study (time frame: After enrollment period, approximately 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04335643, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.