Addressing Disability Effectively With Psychosocial Telemedicine (ADEPT Study): An Open-label, Multicenter Pragmatic Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 715
- 试验地点
- 2
- 主要终点
- Change in the IBD Disability Index
研究概览
简要总结
This multi-site study will be implemented at 5 gastroenterology practices to recruit 420 adults with IBD to complete a baseline survey and enroll those with higher scores on a validated IBD-disability scale into a randomized controlled trial of telehealth-delivered cognitive behavioral therapy with a licensed psychologist versus usual care. The investigators aim to lay the foundations that will shift the paradigm of IBD clinical practice towards a new horizon of holistic and equitable high-value care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years old with a diagnosis of Crohn's disease (CD) or ulcerative colitis (UC)
- •Willingness to complete the baseline survey online. Participants in Aim 1 with moderate-to-severe disability based on the IBD Disability Index (IBD-DI) will be invited to the Aim 2 clinical trial
- •Able to consent and complete surveys in English.
排除标准
- •no/low disability (IBD-DI <35) on the baseline survey
- •inability or unwillingness to participate in telemedicine with a therapist
- •Have an existing relationship with a mental health specialist within the past 3 months
- •Lack of access to a computer, working internet connection, and a private environment to complete teletherapy sessions if they are randomized to this intervention
研究组 & 干预措施
Control
Tele-CBT
干预措施: Tele-CBT (Behavioral)
结局指标
主要结局
Change in the IBD Disability Index
时间窗: 8 weeks
Change in the IBD Disability is estimated by the 14-item validated IBD Disability Index (IBD-DI) in the intervention group (telemedicine-delivered psychosocial care) vs control group (usual care) in patients with moderate-to-severe baseline IBD-related disability pre and post intervention (week 0 and week 8). Total score ranges from 0-100, interpreted as 0-20 (no disability), 20-35 (mild disability), 35-50 (moderate disability), and 50-100 (severe disability).
次要结局
- Cost-benefits of telemedicine-delivered psychosocial care(8 weeks)