NCT Number: NCT04335643
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.
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Notify Me12 year–22 year
All sexes
Interventional
Not applicable
The Hospital for Sick Children, Toronto, Ontario, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TEACH is a remotely delivered psychological intervention. It consists of six one-hour weekly sessions that are HIPAA compliant and conducted over video conferencing.
Other names: Treatment and Education Approach for Childhood-onset Lupus
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.
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.
Time frame: Approximately 8 weeks
Feasibility will be measured by participant feedback in a qualitative interview.
Time frame: 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.
Time frame: Approximately 8 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.
Time frame: 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.
Time frame: 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.
Time frame: Approximately 8 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.
Time frame: 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.
Time frame: 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.
Time frame: Approximately 8 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
Time frame: 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
Time frame: 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."
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Michigan State University
Other
A Remotely Delivered CBT Intervention for Youth With cSLE: A Multi-site Patient-engaged Investigation
Acronym: cSLE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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