Telehealth CBT for Adolescents and Young Adults With Childhood-onset Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

— cSLE  

Official title:

A Remotely Delivered CBT Intervention for Youth With cSLE: A Multi-site Patient-engaged Investigation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04335643
• Other study ID #: STUDY00003882
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 4, 2020
• Est. completion date: August 24, 2024

Study information

• Verified date: May 2023
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 lupus.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: August 24, 2024
• Est. primary completion date: March 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Behavioral:
• TEACH
TEACH is a remotely delivered psychological intervention. It consists of six one-hour weekly sessions that are HIPAA compliant and conducted over video conferencing.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario
United States	Michigan State University	Grand Rapids	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Michigan State University	Arthritis Foundation, The Hospital for Sick Children

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in pain, as measured by the Pain Visual Analog Scale (VAS)	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.	Approximately 4 weeks
Other	Changes in pain, as measured by the Pain Visual Analog Scale (VAS)	The Pain VAS measures three items on a scale of 0-10, with 0 indicating no pain and 10 indicating the worst possible pain	Approximately 8 weeks
Other	Long-term changes in pain, as measured by the Pain Visual Analog Scale (VAS)	The Pain VAS measures three items on a scale of 0-10, with 0 indicating no pain and 10 indicating the worst possible pain	Between 20 and 32 weeks, and between 12-27 months from post-assessment
Other	The number of adverse childhood experiences, as measured by Adverse Childhood Events (ACEs)	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."	Through study completion, up to 32 weeks, and between 12-27 months from post-assessment
Other	Changes in caregivers' depression, anxiety, and stress as measured by the Depression Anxiety and Stress Scales 21 (DASS21)	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.	Approximately 8 weeks
Other	Long-term changes in caregivers' depression, anxiety, and stress as measured by the Depression Anxiety and Stress Scales 21 (DASS21)	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.	Between 20 and 32 weeks, and between 12-27 months from post-assessment
Other	Changes in disease activity as measured by a Visual Analog Scale (VAS)	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.	Approximately 8 weeks
Other	Long-term changes in disease activity as measured by a Visual Analog Scale (VAS)	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.	Between 20 and 32 weeks, and between 12-27 months from post-assessment
Other	Changes in quality of life, as measured by the Pediatric Quality of Life (PedsQL)	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	Approximately 8 weeks
Other	Long-term changes in quality of life, as measured by the Pediatric Quality of Life (PedsQL)	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	Between 20 and 32 weeks, and between 12-27 months from post-assessment
Other	Changes in pain interference, as measured by the PROMIS Pain Interference Short Form (SF)	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.	Approximately 8 weeks
Other	Long-term changes in pain interference, as measured by the PROMIS Pain Interference Short Form (SF)	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.	Between 20 and 32 weeks, and between 12-27 months from post-assessment
Other	Changes in anxiety, as measured by the Screen for Child Anxiety Related Disorders (SCARED) and Screen for Adult Anxiety Related Disorders (SCAARED)	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).	Approximately 8 weeks
Other	Long-term changes in anxiety, as measured by the Screen for Child Anxiety Related Disorders (SCARED) and Screen for Adult Anxiety Related Disorders (SCAARED)	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).	Between 20 and 32 weeks, and between 12-27 months from post-assessment
Other	Changes in disease activity, as measured by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K)	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.	Approximately 8 weeks
Other	Long-term changes in disease activity, as measured by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K)	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.	Between 20 and 32 weeks, and between 12-27 months from post-assessment
Other	Changes in disease activity, as measured by the Systemic Lupus International Collaborating Clinics/ACR Damage Index for Systemic Lupus Erythematosus (SLICC)	The SLICC measures disease activity by assessing descriptors in SLE. Higher scores indicate greater disease activity, lower scores indicate lesser disease activity	Approximately 8 weeks
Other	Long-term changes in disease activity, as measured by the Systemic Lupus International Collaborating Clinics/ACR Damage Index for Systemic Lupus Erythematosus (SLICC)	The SLICC measures disease activity by assessing descriptors in SLE. Higher scores indicate greater disease activity, lower scores indicate lesser disease activity	Between 20 and 32 weeks, and between 12-27 months from post-assessment
Other	Changes in resilience, as measured by the Brief Resilience Scale (BRS)	The BRS measures resilience on a scale of 1 to 5 such that higher scores indicate greater resilience and lower scores indicate lower resilience.	Approximately 8 weeks
Other	Long-term changes in resilience, as measured by the Brief Resilience Scale (BRS)	The BRS measures resilience on a scale of 1 to 5 such that higher scores indicate greater resilience and lower scores indicate lower resilience.	Between 20 and 32 weeks, and between 12-27 months from post-assessment
Other	Changes in medication adherence, as measured by the Medication Adherence Self-Report Inventory (MASRI)	The MASRI measures medication adherence on a scale of 0%-100%, such that lower scores indicate less adherence and higher scores indicate more adherence.	Approximately 8 weeks
Other	Long-term changes in medication adherence, as measured by the Medication Adherence Self-Report Inventory (MASRI)	The MASRI measures medication adherence on a scale of 0%-100%, such that lower scores indicate less adherence and higher scores indicate more adherence.	Between 20 and 32 weeks, and between 12-27 months from post-assessment
Other	Concomitant medications	Medications will be collect through medical charts and reported by participants and caregivers of participants who are under 18 years.	Through study completion, up to 32 weeks, and between 12-27 months from post-assessment
Other	Changes in COVID-related distress as measured by a Visual Analog Scale (VAS)	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	Approximately 8 weeks
Other	Long-term changes in COVID-related distress as measured by a Visual Analog Scale (VAS)	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	Between 20 and 32 weeks, and between 12-27 months from post-assessment
Other	Negative Treatment Effects as measured by the Negative Effects Questionnaire 20 (NEQ)	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.	Between 8 and 32 weeks, and between 12-27 months from post-assessment
Primary	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.	After enrollment period, approximately 2 years
Primary	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.	After data collection period, approximately 2 years
Primary	Feasibility of remotely-delivered TEACH	Feasibility will be measured by participant feedback in a qualitative interview.	Approximately 8 weeks
Secondary	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.	Approximately 4 weeks
Secondary	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.	Approximately 8 weeks
Secondary	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.	Between 20 and 32 weeks, and 12-27 from post-assessment
Secondary	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.	Approximately 4 weeks
Secondary	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.	Approximately 8 weeks
Secondary	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.	Between 20 and 32 weeks, and 12-27 from post-assessment