Worm-Smeitink Margreet, Janse Anthonie, van Dam Arno, Evers Andrea, van der Vaart Rosalie, Wensing Michel, Knoop Hans
Department of Medical Psychology, Radboud University Medical Center, Nijmegen, Netherlands.
Specialist Center for Complex Medically Unexplained Symptoms and Somatic Symptom Disorders, Dimence, Deventer, Netherlands.
J Med Internet Res. 2019 Mar 14;21(3):e11276. doi: 10.2196/11276.
Internet-based cognitive behavioral therapy (I-CBT) leads to a reduction of fatigue severity and disability in adults with chronic fatigue syndrome (CFS). However, not all patients profit and it remains unclear how I-CBT is best embedded in the care of CFS patients.
This study aimed to compare the efficacy of stepped care, using therapist-assisted I-CBT, followed by face-to-face (f2f) cognitive behavioral therapy (CBT) when needed, with f2f CBT (treatment as usual [TAU]) on fatigue severity. The secondary aim was to investigate treatment efficiency.
A total of 363 CFS patients were randomized to 1 of the 3 treatment arms (n=121). There were 2 stepped care conditions that differed in the therapists' feedback during I-CBT: prescheduled or on-demand. When still severely fatigued or disabled after I-CBT, the patients were offered f2f CBT. Noninferiority of both stepped care conditions to TAU was tested using analysis of covariance. The primary outcome was fatigue severity (Checklist Individual Strength). Disabilities (Sickness Impact Profile -8), physical functioning (Medical Outcomes Survey Short Form-36), psychological distress (Symptom Checklist-90), and proportion of patients with clinically significant improvement in fatigue were the secondary outcomes. The amount of invested therapist time was compared between stepped care and TAU. Exploratory comparisons were made between the stepped care conditions of invested therapist time and proportion of patients who continued with f2f CBT.
Noninferiority was indicated, as the upper boundary of the one-sided 98.75% CI of the difference in the change in fatigue severity between both forms of stepped care and TAU were below the noninferiority margin of 5.2 (4.25 and 3.81, respectively). The between-group differences on the secondary outcomes were also not significant (P=.11 to P=.79). Both stepped care formats required less therapist time than TAU (median 8 hours, 9 minutes and 7 hours, 25 minutes in stepped care vs 12 hours in TAU; P<.001). The difference in therapist time between both stepped care formats was not significant. Approximately half of the patients meeting step-up criteria for f2f CBT after I-CBT did not continue.
Stepped care, including I-CBT followed by f2f CBT when indicated, is noninferior to TAU of f2f CBT and requires less therapist time. I-CBT for CFS can be used as a first step in stepped care.
Nederlands Trial Register NTR4809; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4809 (Archived by WebCite at http://www.webcitation.org/74SWkw1V5).
基于互联网的认知行为疗法（I-CBT）可减轻慢性疲劳综合征（CFS）成人患者的疲劳严重程度和残疾程度。然而，并非所有患者都能从中获益，目前尚不清楚如何将I-CBT最佳地融入CFS患者的护理中。
本研究旨在比较阶梯式护理（使用治疗师辅助的I-CBT，必要时进行面对面（f2f）认知行为疗法（CBT））与f2f CBT（常规治疗[TAU]）对疲劳严重程度的疗效。次要目的是调查治疗效率。
总共363例CFS患者被随机分配到3个治疗组中的1组（n = 121）。有2种阶梯式护理条件，在I-CBT期间治疗师的反馈有所不同：预定或按需。在I-CBT后仍严重疲劳或残疾的患者可接受f2f CBT。使用协方差分析测试两种阶梯式护理条件相对于TAU的非劣效性。主要结局是疲劳严重程度（个人力量检查表）。残疾（疾病影响概况-8）、身体功能（医学结果调查简表-36）、心理困扰（症状清单-90）以及疲劳有临床显著改善的患者比例为次要结局。比较阶梯式护理和TAU之间投入的治疗师时间量。对投入的治疗师时间和继续接受f2f CBT的患者比例的阶梯式护理条件进行探索性比较。
表明具有非劣效性，因为两种形式的阶梯式护理与TAU之间疲劳严重程度变化差异的单侧98.75%CI的上限低于非劣效界值5.2（分别为4.25和3.81）。次要结局的组间差异也不显著（P = 0.11至P = 0.79）。两种阶梯式护理形式所需的治疗师时间均少于TAU（阶梯式护理中位数为8小时9分钟和7小时25分钟，而TAU为12小时；P < 0.001）。两种阶梯式护理形式之间的治疗师时间差异不显著。I-CBT后符合f2f CBT升级标准的患者中约有一半没有继续接受治疗。
阶梯式护理，包括I-CBT，必要时进行f2f CBT，不劣于f2f CBT的TAU，且所需治疗师时间更少。CFS的I-CBT可用作阶梯式护理的第一步。
荷兰试验注册NTR4809；http://www.trialregister.nl/trialreg/admin/rctview.asp?TC = 4809（由WebCite存档于http://www.webcitation.org/74SWkw1V5）
