Clinical trial NCT04335643: Telehealth CBT for Adolescents and Young Adults With Childhood-onset Systemic Lupus Erythematosus
Official title: A Remotely Delivered CBT Intervention for Youth With cSLE: A Multi-site Patient-engaged Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: lupus
depression
depressive symptoms
fatigue
pain
SLE
rheumatic disease
rheumatology
telehealth
CBT
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Arthritis Foundation
name: The Hospital for Sick Children
First posted: 2020-04-06
Enrollment: 65
Sex: ALL
Minimum age (years): 12
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will either be randomly assigned to the intervention or to a wait-list period.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Recruitment rates of the study
timeFrame: After enrollment period, approximately 2 years
measure: Retention rates of the study
timeFrame: After data collection period, approximately 2 years
measure: Feasibility of remotely-delivered TEACH
timeFrame: Approximately 8 weeks
Secondary outcomes:
measure: Changes in fatigue, as measured by the PROMIS Fatigue SF
timeFrame: Approximately 4 weeks
measure: Changes in fatigue, as measured by the PROMIS Fatigue SF
timeFrame: Approximately 8 weeks
measure: Long-term changes in fatigue, as measured by the PROMIS Fatigue SF
timeFrame: Between 20 and 32 weeks, and 12-27 from post-assessment
measure: Changes in depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II)
timeFrame: Approximately 4 weeks
measure: Changes in depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II)
timeFrame: Approximately 8 weeks
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)
timeFrame: Between 20 and 32 weeks, and 12-27 from post-assessment
Other outcomes:
measure: Changes in pain, as measured by the Pain Visual Analog Scale (VAS)
timeFrame: Approximately 4 weeks
measure: Changes in pain, as measured by the Pain Visual Analog Scale (VAS)
timeFrame: Approximately 8 weeks
measure: Long-term changes in pain, as measured by the Pain Visual Analog Scale (VAS)
timeFrame: Between 20 and 32 weeks, and between 12-27 months from post-assessment
measure: The number of adverse childhood experiences, as measured by Adverse Childhood Events (ACEs)
timeFrame: Through study completion, up to 32 weeks, and between 12-27 months from post-assessment
measure: Changes in caregivers' depression, anxiety, and stress as measured by the Depression Anxiety and Stress Scales 21 (DASS21)
timeFrame: Approximately 8 weeks
measure: Long-term changes in caregivers' depression, anxiety, and stress as measured by the Depression Anxiety and Stress Scales 21 (DASS21)
timeFrame: Between 20 and 32 weeks, and between 12-27 months from post-assessment
measure: Changes in disease activity as measured by a Visual Analog Scale (VAS)
timeFrame: Approximately 8 weeks
measure: Long-term changes in disease activity as measured by a Visual Analog Scale (VAS)
timeFrame: Between 20 and 32 weeks, and between 12-27 months from post-assessment
measure: Changes in quality of life, as measured by the Pediatric Quality of Life (PedsQL)
timeFrame: Approximately 8 weeks
measure: Long-term changes in quality of life, as measured by the Pediatric Quality of Life (PedsQL)
timeFrame: Between 20 and 32 weeks, and between 12-27 months from post-assessment
measure: Changes in pain interference, as measured by the PROMIS Pain Interference Short Form (SF)
timeFrame: Approximately 8 weeks
measure: Long-term changes in pain interference, as measured by the PROMIS Pain Interference Short Form (SF)
timeFrame: Between 20 and 32 weeks, and between 12-27 months from post-assessment
measure: Changes in anxiety, as measured by the Screen for Child Anxiety Related Disorders (SCARED) and Screen for Adult Anxiety Related Disorders (SCAARED)
timeFrame: Approximately 8 weeks
measure: Long-term changes in anxiety, as measured by the Screen for Child Anxiety Related Disorders (SCARED) and Screen for Adult Anxiety Related Disorders (SCAARED)
timeFrame: Between 20 and 32 weeks, and between 12-27 months from post-assessment
measure: Changes in disease activity, as measured by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K)
timeFrame: Approximately 8 weeks
measure: Long-term changes in disease activity, as measured by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K)
timeFrame: Between 20 and 32 weeks, and between 12-27 months from post-assessment
measure: Changes in disease activity, as measured by the Systemic Lupus International Collaborating Clinics/ACR Damage Index for Systemic Lupus Erythematosus (SLICC)
timeFrame: Approximately 8 weeks
measure: Long-term changes in disease activity, as measured by the Systemic Lupus International Collaborating Clinics/ACR Damage Index for Systemic Lupus Erythematosus (SLICC)
timeFrame: Between 20 and 32 weeks, and between 12-27 months from post-assessment
measure: Changes in resilience, as measured by the Brief Resilience Scale (BRS)
timeFrame: Approximately 8 weeks
measure: Long-term changes in resilience, as measured by the Brief Resilience Scale (BRS)
timeFrame: Between 20 and 32 weeks, and between 12-27 months from post-assessment
measure: Changes in medication adherence, as measured by the Medication Adherence Self-Report Inventory (MASRI)
timeFrame: Approximately 8 weeks
measure: Long-term changes in medication adherence, as measured by the Medication Adherence Self-Report Inventory (MASRI)
timeFrame: Between 20 and 32 weeks, and between 12-27 months from post-assessment
measure: Concomitant medications
timeFrame: Through study completion, up to 32 weeks, and between 12-27 months from post-assessment
measure: Changes in COVID-related distress as measured by a Visual Analog Scale (VAS)
timeFrame: Approximately 8 weeks
measure: Long-term changes in COVID-related distress as measured by a Visual Analog Scale (VAS)
timeFrame: Between 20 and 32 weeks, and between 12-27 months from post-assessment
measure: Negative Treatment Effects as measured by the Negative Effects Questionnaire 20 (NEQ)
timeFrame: Between 8 and 32 weeks, and between 12-27 months from post-assessment
Locations:
city: Grand Rapids
country: United States
facility: Michigan State University
state: Michigan
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Michigan State University
name: Natoshia Cunningham, PhD
role: PRINCIPAL_INVESTIGATOR
References: