Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
Gustavsberg Academic Primary Care Clinic, Gustavsberg, Sweden.
JAMA Psychiatry. 2020 Sep 1;77(9):915-924. doi: 10.1001/jamapsychiatry.2020.0940.
Health anxiety is a common and often chronic mental health problem associated with distress, substantial costs, and frequent attendance throughout the health care system. Face-to-face cognitive behavior therapy (CBT) is the criterion standard treatment, but access is limited.
To test the hypothesis that internet-delivered CBT, which requires relatively little resources, is noninferior to face-to-face CBT in the treatment of health anxiety.
DESIGN, SETTING, AND PARTICIPANTS: This randomized noninferiority clinical trial with health economic analysis was based at a primary care clinic and included patients with a principal diagnosis of health anxiety who were self-referred or referred from routine care. Recruitment began in December 10, 2014, and the last treatment ended on July 23, 2017. Follow-up data were collected up to 12 months after treatment. Analysis began October 2017 and ended March 2020.
Patients were randomized (1:1) to 12 weeks of internet-delivered CBT or to individual face-to-face CBT.
Change in health anxiety symptoms from baseline to week 12. Analyses were conducted from intention-to-treat and per-protocol (completers only) perspectives, using the noninferiority margin of 2.25 points on the Health Anxiety Inventory, which has a theoretical range of 0 to 54.
Overall, 204 patients (mean [SD] age, 39 [12] years; 143 women [70%]) contributed with 2386 data points on the Health Anxiety Inventory over the treatment period. Of 204 patients, 102 (50%) were randomized to internet-delivered CBT, and 102 (50%) were randomized to face-to-face CBT. The 1-sided 95% CI upper limits for the internet-delivered CBT vs face-to-face CBT difference in change were within the noninferiority margin in the intention-to-treat analysis (B = 0.00; upper limit: 1.98; Cohen d = 0.00; upper limit: 0.23) and per-protocol analysis (B = 0.01; upper limit: 2.17; Cohen d = 0.00; upper limit: 0.25). The between-group effect was not moderated by initial symptom level, recruitment path, or patient treatment preference. Therapists spent 10.0 minutes per patient per week in the online treatment vs 45.6 minutes for face-to-face CBT. The net societal cost was lower in the online treatment (treatment period point difference: $3854). There was no significant group difference in the number of adverse events, and no serious adverse event was reported.
In this trial, internet-delivered CBT appeared to be noninferior to face-to-face CBT for health anxiety, while incurring lower net societal costs. The online treatment format has potential to increase access to evidence-based treatment for health anxiety.
ClinicalTrials.gov Identifier: NCT02314065.
健康焦虑是一种常见且通常为慢性的心理健康问题，与痛苦、大量成本以及在整个医疗保健系统中频繁就诊有关。面对面的认知行为疗法（CBT）是标准的治疗方法，但可及性有限。
检验假设，即相对需要较少资源的互联网提供的 CBT 在治疗健康焦虑方面不亚于面对面的 CBT。
设计、地点和参与者：这是一项基于初级保健诊所的随机非劣效性临床试验，包括自我转诊或常规护理转诊的主要诊断为健康焦虑的患者。招募于 2014 年 12 月 10 日开始，最后一次治疗于 2017 年 7 月 23 日结束。随访数据收集持续到治疗后 12 个月。分析于 2017 年 10 月开始，2020 年 3 月结束。
患者被随机（1:1）分配到 12 周的互联网提供的 CBT 或个人面对面的 CBT。
从基线到第 12 周健康焦虑症状的变化。分析从意向治疗和按方案（仅完成者）的角度进行，使用健康焦虑量表的非劣效性边界为 2.25 分，该量表的理论范围为 0 至 54。
总的来说，204 名患者（平均[标准差]年龄 39[12]岁；143 名女性[70%]）在治疗期间提供了 2386 个健康焦虑量表数据点。在 204 名患者中，102 名（50%）被随机分配到互联网提供的 CBT，102 名（50%）被随机分配到面对面的 CBT。意向治疗分析中互联网提供的 CBT 与面对面 CBT 变化差异的单侧 95%CI 上限在非劣效性边界内（B=0.00；上限：1.98；Cohen d=0.00；上限：0.23）和按方案分析（B=0.01；上限：2.17；Cohen d=0.00；上限：0.25）。治疗组之间的差异不受初始症状水平、招募途径或患者治疗偏好的影响。治疗师每周在在线治疗中为每位患者花费 10.0 分钟，而面对面 CBT 则花费 45.6 分钟。在线治疗的净社会成本较低（治疗期间点差异：$3854）。两组在不良事件数量上没有显著差异，也没有报告严重不良事件。
在这项试验中，互联网提供的 CBT 似乎与面对面的 CBT 一样，对健康焦虑具有非劣效性，同时产生的净社会成本较低。在线治疗模式有可能增加对健康焦虑的循证治疗的可及性。
ClinicalTrials.gov 标识符：NCT02314065。
