Systemic Lupus Erythematosus
Conditions
Keywords
lupus, depression, depressive symptoms, fatigue, pain, SLE, rheumatic disease, rheumatology, telehealth, CBT
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.
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.
Interventions
BEHAVIORALTEACH
TEACH is a remotely delivered psychological intervention. It consists of six one-hour weekly sessions that are HIPAA compliant and conducted over video conferencing.
Sponsors
Arthritis Foundation
The Hospital for Sick Children
Michigan State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will either be randomly assigned to the intervention or to a wait-list period.
Eligibility
Sex/Gender
ALL
Age
12 Years to 22 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rates of the study | 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 | 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 | Approximately 8 weeks | Feasibility will be measured by participant feedback in a qualitative interview. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in fatigue, as measured by the PROMIS Fatigue SF | Approximately 4 weeks | 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. |
| Long-term changes in depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II) | Between 20 and 32 weeks, and 12-27 from post-assessment | 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. |
| Long-term changes in fatigue, as measured by the PROMIS Fatigue SF | Between 20 and 32 weeks, and 12-27 from post-assessment | 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. |
| 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in quality of life, as measured by the Pediatric Quality of Life (PedsQL) | Approximately 8 weeks | The PedsQL measures quality of life in several aspects such as health, school, daily activities. Each item is reversed scored and transformed to a linear scale of 0-100, such that 100 indicates a high quality of life and 0 indicates a low quality of life |
| Long-term changes in quality of life, as measured by the Pediatric Quality of Life (PedsQL) | Between 20 and 32 weeks, and between 12-27 months from post-assessment | The PedsQL measures quality of life in several aspects such as health, school, daily activities. Each item is reversed scored and transformed to a linear scale of 0-100, such that 100 indicates a high quality of life and 0 indicates a low quality of life |
| Changes in pain interference, as measured by the PROMIS Pain Interference Short Form (SF) | Approximately 8 weeks | The PROMIS Pain Interference SF measures how pain interferes with aspects of life, such as daily activities or family life. Scores range from 8 to 40 for adults and 0 to 32 for children, such that lower scores indicate little pain interference and high scores indicate high pain interference. |
| Long-term changes in pain interference, as measured by the PROMIS Pain Interference Short Form (SF) | Between 20 and 32 weeks, and between 12-27 months from post-assessment | The PROMIS Pain Interference SF measures how pain interferes with aspects of life, such as daily activities or family life. Scores range from 8 to 40 for adults and 0 to 32 for children, such that lower scores indicate little pain interference and high scores indicate high pain interference. |
| Changes in anxiety, as measured by the Screen for Child Anxiety Related Disorders (SCARED) and Screen for Adult Anxiety Related Disorders (SCAARED) | Approximately 8 weeks | The SCARED measures anxiety in children on a scale of 0 to 82, such that lower scores indicates low levels of anxiety, and high scores indicated high levels of anxiety. The SCAARED measures anxiety in adults on a scale of 0 to 88 such that lower scores indicated lower levels of anxiety and high scores indicate higher levels of anxiety. Both scales are comprised of sub-scales to measure types of anxiety (such as separation anxiety). |
| Long-term changes in anxiety, as measured by the Screen for Child Anxiety Related Disorders (SCARED) and Screen for Adult Anxiety Related Disorders (SCAARED) | Between 20 and 32 weeks, and between 12-27 months from post-assessment | The SCARED measures anxiety in children on a scale of 0 to 82, such that lower scores indicates low levels of anxiety, and high scores indicated high levels of anxiety. The SCAARED measures anxiety in adults on a scale of 0 to 88 such that lower scores indicated lower levels of anxiety and high scores indicate higher levels of anxiety. Both scales are comprised of sub-scales to measure types of anxiety (such as separation anxiety). |
| Changes in disease activity, as measured by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) | Approximately 8 weeks | The SLEDAI 2K measures disease activity in SLE, and takes into consideration descriptors of the disease such as arthritis and vasculitis. Higher scores indicate more active disease/flares, and lower scores indicated less disease activity. |
| Long-term changes in disease activity, as measured by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) | Between 20 and 32 weeks, and between 12-27 months from post-assessment | The SLEDAI 2K measures disease activity in SLE, and takes into consideration descriptors of the disease such as arthritis and vasculitis. Higher scores indicate more active disease/flares, and lower scores indicated less disease activity. |
| Changes in disease activity, as measured by the Systemic Lupus International Collaborating Clinics/ACR Damage Index for Systemic Lupus Erythematosus (SLICC) | Approximately 8 weeks | The SLICC measures disease activity by assessing descriptors in SLE. Higher scores indicate greater disease activity, lower scores indicate lesser disease activity |
| Changes in pain, as measured by the Pain Visual Analog Scale (VAS) | Approximately 4 weeks | The Pain VAS measures three items on a scale of 0-10, with 0 indicating no pain and 10 indicating the worst possible pain. This is to assess changes at a midpoint in the study. |
| Changes in resilience, as measured by the Brief Resilience Scale (BRS) | Approximately 8 weeks | The BRS measures resilience on a scale of 1 to 5 such that higher scores indicate greater resilience and lower scores indicate lower resilience. |
| Long-term changes in resilience, as measured by the Brief Resilience Scale (BRS) | Between 20 and 32 weeks, and between 12-27 months from post-assessment | The BRS measures resilience on a scale of 1 to 5 such that higher scores indicate greater resilience and lower scores indicate lower resilience. |
| Changes in medication adherence, as measured by the Medication Adherence Self-Report Inventory (MASRI) | Approximately 8 weeks | The MASRI measures medication adherence on a scale of 0%-100%, such that lower scores indicate less adherence and higher scores indicate more adherence. |
| Long-term changes in medication adherence, as measured by the Medication Adherence Self-Report Inventory (MASRI) | Between 20 and 32 weeks, and between 12-27 months from post-assessment | The MASRI measures medication adherence on a scale of 0%-100%, such that lower scores indicate less adherence and higher scores indicate more adherence. |
| Concomitant medications | Through study completion, up to 32 weeks, and between 12-27 months from post-assessment | Medications will be collect through medical charts and reported by participants and caregivers of participants who are under 18 years. |
| Changes in COVID-related distress as measured by a Visual Analog Scale (VAS) | Approximately 8 weeks | COVID-related distress will be measured through two items on a VAS ranging from 0-10, with 0 indicated no distress and 10 indicating extreme distress |
| Long-term changes in COVID-related distress as measured by a Visual Analog Scale (VAS) | Between 20 and 32 weeks, and between 12-27 months from post-assessment | COVID-related distress will be measured through two items on a VAS ranging from 0-10, with 0 indicated no distress and 10 indicating extreme distress |
| Negative Treatment Effects as measured by the Negative Effects Questionnaire 20 (NEQ) | Between 8 and 32 weeks, and between 12-27 months from post-assessment | The 20-item NEQ measures negative effects and their impact experienced from psychological treatment. The NEQ measures frequency of negative events on a scale of 0-20. If a negative event is indicated, participants are asked to indicate the severity of its impact on a scale of 0-4 with higher ratings indicating greater severity. |
| Long-term changes in disease activity, as measured by the Systemic Lupus International Collaborating Clinics/ACR Damage Index for Systemic Lupus Erythematosus (SLICC) | Between 20 and 32 weeks, and between 12-27 months from post-assessment | The SLICC measures disease activity by assessing descriptors in SLE. Higher scores indicate greater disease activity, lower scores indicate lesser disease activity |
| 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 | The Pain VAS measures three items on a scale of 0-10, with 0 indicating no pain and 10 indicating the worst possible pain |
| The number of adverse childhood experiences, as measured by Adverse Childhood Events (ACEs) | Through study completion, up to 32 weeks, and between 12-27 months from post-assessment | The ACEs questionnaire poses 9 different potential adverse childhood experiences in which participants indicate if they have or have not had that experience. The total is calculated by adding the items indicated as yes. |
| Changes in caregivers' depression, anxiety, and stress as measured by the Depression Anxiety and Stress Scales 21 (DASS21) | Approximately 8 weeks | The DASS21 depression, anxiety, and stress on a scale of 0-63 with 0 indicating low levels of these feelings, and 63 indicating high levels. This measure will only be completed by caregivers participating in the study. |
| Long-term changes in caregivers' depression, anxiety, and stress as measured by the Depression Anxiety and Stress Scales 21 (DASS21) | Between 20 and 32 weeks, and between 12-27 months from post-assessment | The DASS21 depression, anxiety, and stress on a scale of 0-63 with 0 indicating low levels of these feelings, and 63 indicating high levels. This measure will only be completed by caregivers participating in the study. |
| Changes in disease activity as measured by a Visual Analog Scale (VAS) | Approximately 8 weeks | Disease activity will be measured by the physician on a VAS ranging from 0, indicating no activity, to 10 indicating high activity. This VAS used will be from the pediatric global health assessment. |
| Long-term changes in disease activity as measured by a Visual Analog Scale (VAS) | Between 20 and 32 weeks, and between 12-27 months from post-assessment | Disease activity will be measured by the physician on a VAS ranging from 0, indicating no activity, to 10 indicating high activity. This VAS used will be from the pediatric global health assessment. |
Countries
Canada, United States
Outcome results
None listed