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.
Brief Title
Telehealth CBT for Adolescents and Young Adults With Childhood-onset Systemic Lupus Erythematosus
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Systemic Lupus Erythematosus
Eligibility Criteria
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.
* 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.
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Keywords
lupus
depression
depressive symptoms
fatigue
pain
SLE
rheumatic disease
rheumatology
telehealth
CBT
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
22 Years
Minimum Age
12 Years
NCT Id
NCT04335643
Org Class
Other
Org Full Name
Michigan State University
Org Study Id
STUDY00003882
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Remotely Delivered CBT Intervention for Youth With cSLE: A Multi-site Patient-engaged Investigation
Primary Outcomes
Outcome Description
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.
Outcome Measure
Recruitment rates of the study
Outcome Time Frame
After enrollment period, approximately 2 years
Outcome Description
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.
Outcome Measure
Retention rates of the study
Outcome Time Frame
After data collection period, approximately 2 years
Outcome Description
Feasibility will be measured by participant feedback in a qualitative interview.
Outcome Measure
Feasibility of remotely-delivered TEACH
Outcome Time Frame
Approximately 8 weeks
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Approximately 4 weeks
Outcome Measure
Changes in fatigue, as measured by the PROMIS Fatigue SF
Outcome Description
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.
Outcome Time Frame
Approximately 8 weeks
Outcome Measure
Changes in fatigue, as measured by the PROMIS Fatigue SF
Outcome Description
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.
Outcome Time Frame
Between 20 and 32 weeks, and 12-27 from post-assessment
Outcome Measure
Long-term changes in fatigue, as measured by the PROMIS Fatigue SF
Outcome Description
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.
Outcome Time Frame
Approximately 4 weeks
Outcome Measure
Changes in depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II)
Outcome Description
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.
Outcome Time Frame
Approximately 8 weeks
Outcome Measure
Changes in depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II)
Outcome Description
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.
Outcome Time Frame
Between 20 and 32 weeks, and 12-27 from post-assessment
Outcome Measure
Long-term changes in depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
22
Minimum Age Number (converted to Years and rounded down)
12
Investigators
Investigator Type
Principal Investigator
Investigator Name
Tamar Rubinstein
Investigator Email
trubinst@montefiore.org
Investigator Phone
718-969-2604