Nghiên cứu ReThink: một thử nghiệm ngẫu nhiên đối chứng ba nhánh về sửa đổi thiên lệch nhận thức, có và không có sự thúc đẩy tuân thủ, cho rối loạn lo âu ở thanh thiếu niên: thiết kế và giao thức thử nghiệm

BMC Psychiatry - Tập 19 - Trang 1-14 - 2019
Shelley Reetz1, Gregory Clarke1, Robin Weersing2,3, Nader Amir2,3, John Dickerson1, Frances L. Lynch1, Michael C. Leo1, Andreea M. Rawlings1, Mi H. Lee1, Sara Gille1
1Kaiser Permanente Center for Health Research, Portland, USA
2San Diego State University (SDSU), San Diego, USA
3Center for Understanding and Treating Anxiety, San Diego State University (SDSU), San Diego, USA

Tóm tắt

Các rối loạn lo âu là vấn đề sức khỏe tâm thần phổ biến nhất ở thanh thiếu niên, góp phần làm giảm chất lượng cuộc sống hàng ngày và liên quan đến tỷ lệ mắc bệnh đi kèm cao. Tuy nhiên, tỷ lệ điều trị các rối loạn lo âu rất thấp, tạo ra một khoảng trống điều trị lớn. Có một nhu cầu cấp thiết để xác định các can thiệp điều trị hiệu quả, tiết kiệm và có thể dễ dàng triển khai đến đối tượng thanh thiếu niên. Sửa đổi Thiên lệch Nhận thức (CBM) là một can thiệp tiềm năng có thể hiệu quả để tiếp cận số lượng lớn thanh thiếu niên, đặc biệt khi được thực hiện tự quản tại nhà. Do đó, chúng tôi đặt mục tiêu đánh giá lợi ích của CBM trong việc điều trị lo âu ở thanh thiếu niên. Hơn nữa, chúng tôi muốn kiểm tra xem việc thêm một thành phần thúc đẩy tuân thủ (AP) vào can thiệp CBM có thể cải thiện kết quả hay không, và liệu CBM được thực hiện có và không có thành phần AP có hiệu quả về mặt chi phí hay không. Đây là một thử nghiệm đối chứng ngẫu nhiên (RCT) kéo dài 12 tháng được thực hiện trong một hệ thống chăm sóc sức khỏe hiện có. Những thanh thiếu niên đủ điều kiện tiềm năng (từ 12 đến 17 tuổi) sẽ được xác định thông qua việc xem xét hồ sơ sức khỏe điện tử (EHR) cho các chẩn đoán lo âu lâm sàng, sau đó được xác nhận qua phỏng vấn nghiên cứu. Chúng tôi dự kiến tuyển chọn 498 người tham gia và ngẫu nhiên hóa họ theo tỷ lệ 1:1:1 vào một trong ba nhánh: Nhánh 1 là phiên bản Tỷ lệ Thấp của chương trình CBM (hầu như giống hệt với các phiên bản CBM khác, nhưng tác dụng tối thiểu); Nhánh 2 là chương trình CBM “hoạt động” Tỷ lệ Cao; và Nhánh 3 là chương trình CBM Tỷ lệ Cao với một thành phần AP bổ sung. Người tham gia sẽ hoàn thành các bài đánh giá tại thời điểm ban đầu, 1, 3, 6 và 12 tháng sau khi bắt đầu. Thanh thiếu niên ở cả ba nhánh sẽ tự quản lý chương trình CBM tại nhà và sẽ được yêu cầu hoàn thành mười hai phiên can thiệp trong một khoảng thời gian bốn tuần. Người tham gia Nhánh 3 (CBM Tỷ lệ Cao + AP) cũng sẽ nhận được tối đa bốn cuộc gọi điện thoại từ các huấn luyện viên điện thoại trong thời gian can thiệp để cung cấp hỗ trợ kỹ thuật, khuyến khích và tăng cường động lực nhằm tăng cường tuân thủ. Kết quả lâm sàng chính sẽ là sự thuyên giảm lo âu tại lần theo dõi 6 tháng. Giao thức nghiên cứu này mô tả phương pháp và thiết kế cho một RCT nhằm kiểm tra xem liệu CBM tự quản lý, có và không có thúc đẩy tuân thủ, có thể là một phương pháp điều trị tại nhà hiệu quả cho thanh thiếu niên bị lo âu hay không.

Từ khóa

#Rối loạn lo âu #thanh thiếu niên #can thiệp #sửa đổi thiên lệch nhận thức #thúc đẩy tuân thủ #thử nghiệm đối chứng ngẫu nhiên

Tài liệu tham khảo

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