Transforming Behavioral Healthcare to Improve the Quality of Life for Individuals With Childhood-onset Lupus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 175
- 试验地点
- 14
- 主要终点
- Psychological stress, as measured by the PROMIS psychological stress experience measure
研究概览
简要总结
This study aims to investigate the feasibility and effectiveness of a cognitive behavioral coping skills program, Treatment and Education Approach for Childhood-onset Lupus (TEACH), for youth with cSLE when integrated into medical care. This TEACH program 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.
详细描述
Background/Rationale: Childhood-onset systemic lupus erythematosus (cSLE) is a chronic, multisystem, autoimmune disease that disproportionately impacts females of color. It is associated with a more severe disease presentation, and a 20-fold increased risk of mortality compared to adult-onset SLE. Depressive symptoms, anxiety, fatigue, and pain are among the most common presenting complaints which impact health-related quality of life (QOL) in individuals with cSLE. These symptoms are potentially modifiable with behavioral intervention. Our team has created an evidence-based, brief and tailored 6-session program, Treatment and Education Approach for Childhood-onset lupus [TEACH], which can be delivered in person or remotely using cognitive behavioral therapy (CBT) strategies to address mental health symptoms, fatigue, and pain. Our nearly completed multi-site RCT, comparing TEACH (delivered by research interventionists) to standard medical care, shows efficacy for psychological/functional outcomes and benefit for disease-related outcomes. Although TEACH is extremely promising, patients do not currently have access to this program as part of their rheumatology care. cSLE patients would likely benefit from TEACH integrated into their medical care, leveraging existing relationships with their providers. As rheumatology teams are often identified as primary providers by cSLE patients, they have a key role in facilitating mental health intervention to enhance patient QOL. They are therefore well-positioned for training in the management of these common, debilitating, yet modifiable symptoms.
Objective: The objective is to determine the effectiveness of a coping skills program, TEACH, designed to improve psychological/functional- and disease- related outcomes in youth with cSLE. We will also investigate longitudinal trajectories of depressive symptoms in recipients and explore implementation outcomes.
Specific Aims & Hypotheses:
Aim 1: To examine the effect of TEACH on psychological/ functional outcomes and disease-related outcomes in youth with cSLE in real-world rheumatology settings versus medical TAU at post assessment (after 8 weeks). We hypothesize that both psychological/functional outcomes (depressive symptoms [primary], fatigue [secondary], anxiety, pain, cognitive function) and disease-related outcomes (health-related QOL, medication adherence, disease activity/flares) will significantly improve for the TEACH group vs medical TAU.
Aim 2: To determine longitudinal trajectories (over 1 year) of depressive symptoms, the impact of TEACH, and its association with patient characteristics, psychological/functional outcomes, and disease-related outcomes. We hypothesize that: i) distinct trajectories of depressive symptoms [low stable, improving, worsening] will emerge through growth mixture modeling, ii) TEACH vs TAU will be associated with decreased depressive symptoms and improved functioning over time, and iii) worsening depressive symptoms will be associated with poorer psychological/functional outcomes & disease-related outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be masked to who received TEACH and who did not.
入排标准
- 年龄范围
- 12 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) be diagnosed with cSLE, meeting the revised American College of Rheumatology Classification Criteria for SLE by age 18 years
- •2) be between the ages of 12 and 22 years
- •3) in recognition of the heterogeneity of cSLE symptoms, have elevations in fatigue (i.e., T scores ≥60; or at least moderate symptoms, on the PROMIS measure) OR depressive symptoms (≥5 on the PHQ-9, T Score ≥ 60 on the BDI or CDI II ), OR pain (i.e., average pain ≥3 out of 10 on the Pain VAS)
- •4) have English language proficiency (their primary caregiver can have English or Spanish language proficiency for the child to enroll)
- •5) those under age 18 years (US), or 16 years (Canada) must have a consenting caregiver
排除标准
- •1) other chronic medical conditions (e.g., juvenile arthritis)
- •2) a documented developmental delay, severe cognitive impairment, or thought disorder
- •3) an untreated major psychiatric illness (e.g., bipolar disorder, psychosis, severe depression (PHQ9 score ≥21, BDI/CDI II > 90) or active suicidal ideation (SI), based on the Pediatric Health Questionnaire (PHQ-9) items plus clinical interview; see Measures section)
结局指标
主要结局
Psychological stress, as measured by the PROMIS psychological stress experience measure
时间窗: T1 (baseline), T2 (8 weeks)
PROMIS psychological stress experience measure is validated for pediatrics and adults. Scores range from 0-95 where 0 indicates no psychological stress and 95 is the maximum score for psychological stress.
Anxiety, as measured by the Screen for Child Anxiety Related Disorders (SCARED) and Screen for Adult Anxiety Related Disorders (SCAARED)
时间窗: T1 (baseline), T2 (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).
Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II) (primary)
时间窗: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 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.
Depressive symptoms, as measured by the Patient Health Questionnaire - 9 (PHQ-9) (primary)
时间窗: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
The PHQ-9 measures depressive symptoms on a scale of 1-27, with 1 indicating low levels of depressive symptoms, and 27 indicating high levels of depressive symptoms.
Fatigue, as measured by the PROMIS Fatigue short form (secondary)
时间窗: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 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.
Pain, as measured by the Pain Visual Analog Scale (VAS)
时间窗: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 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.
Pain, as measured by PROMIS Pain Interference Short Form
时间窗: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
Interference due to pain symptoms over the past week will be collected from youth (0-32, where 0 indicates low levels of pain interference and 32 is the maximum score for pain interference) and adults (8-40, where 8 indicates low levels of pain interference and 40 is the maximum score for pain interference).
Psychological stress, as measured by the PROMIS psychological stress experience measure
时间窗: T1 (baseline), T2 (8 weeks)
PROMIS psychological stress experience measure is validated for pediatrics and adults. Scores range from 0-95 where 0 indicates no psychological stress and 95 is the maximum score for psychological stress.
Cognitive functioning, as measured by the PROMIS Cognitive Function Short Form for Adults and the PROMIS Cognitive Function Short Form for Pediatrics
时间窗: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
PROMIS Cognitive Function Adult form scores range from 8-40, where 8 indicates never having cognitive dysfunction, and 40 indicates very often having cognitive dysfunction. PROMIS Cognitive Function Pediatric form scores range from 7-35, where 7 indicates never having cognitive dysfunction, and 35 indicates having cognitive dysfunction all of the time.
Quality of life, as measured by the Pediatric Quality of Life (PedsQL) Generic Core
时间窗: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 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.
Quality of life, as measured by the Pediatric Quality of Life (PedsQL) Rheumatology Core
时间窗: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
The PedsQL measures quality of life in several aspects such as pain and hurt, daily activities, treatment, worry, and communication. 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.
Medication adherence, as measured by the Medication Adherence Self-Report Inventory (MASRI)
时间窗: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 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.
Disease activity, as measured by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K)
时间窗: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 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.
Disease activity, as measured by the Systemic Lupus International Collaborating Clinics/ACR Damage Index for Systemic Lupus Erythematosus (SLICC)
时间窗: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
The SLICC measures disease activity by assessing descriptors in SLE. Higher scores indicate greater disease activity, lower scores indicate lesser disease activity
Disease activity, as measured by the Lupus Low Disease Activity State (LLDAS)
时间窗: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
The LLDAS is a score from 0-5, where 0 indicates higher disease activity state and 5 indicates lower disease activity state. The LLDAS includes 5 components, each receiving either a 1 (true) or a 0 (false): 1. SLEDAI score less than or equal to 4, 2. no new lupus disease activity, 3. a SELENA-SLEDAI less than or equal to 1, 4. a maintained low prednisolone dose, and 5. well tolerated maintenance doses or immunosuppressive drugs and approved biological agents.
Disease manifestations
时间窗: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
Disease manifestation will be assessed by use of the Systemic Lupus International Collaborating Clinics/ACR Damage Index for Systemic Lupus Erythematosus (SLICC) criteria checklist.
Anxiety, as measured by the Screen for Child Anxiety Related Disorders (SCARED) and Screen for Adult Anxiety Related Disorders (SCAARED)
时间窗: T1 (baseline), T2 (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).
次要结局
- Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II)(T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
- Quality of life, as measured by the Pediatric Quality of Life (PedsQL) Generic Core(T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
- Cognitive functioning, as measured by the PROMIS Cognitive Function Short Form for Adults and the PROMIS Cognitive Function Short Form for Pediatrics(T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
- Fatigue, as measured by the PROMIS Fatigue SF(T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
- Pain, as measured by the Pain Visual Analog Scale (VAS)(T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
- Psychological stress, as measured by the PROMIS psychological stress experience measure(T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
- Medication adherence, as measured by the Medication Adherence Self-Report Inventory (MASRI)(T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
- Disease activity, as measured by the Systemic Lupus International Collaborating Clinics/ACR Damage Index for Systemic Lupus Erythematosus (SLICC)(T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
- Disease activity, as measured by the Lupus Low Disease Activity State (LLDAS)(T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
- Depressive symptoms, as measured by the Patient Health Questionnaire - 9 (PHQ-9) (primary)(T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
- Disease activity, as measured by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K)(T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
- Pain, as measured by PROMIS Pain Interference Short Form(T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
- Quality of life, as measured by the Pediatric Quality of Life (PedsQL) Rheumatology Core(T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
- Disease manifestations(T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
- Anxiety, as measured by the Screen for Child Anxiety Related Disorders (SCARED) and Screen for Adult Anxiety Related Disorders (SCAARED)(T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
研究者
Natoshia Cunningham
Associate Professor
Michigan State University