目的:躯体症状障碍(SSD)的症状是初级保健咨询的最常见原因之一。然而,专业的心理服务大多不可用。这次试点试验旨在确定可行性,可接受性,以及针对初级保健中SSD患者的综合心理健康视频咨询VISION模型的安全性。
方法:我们进行了平行组,随机对照试点试验,涉及来自德国10个初级保健实践的51名SSD患者,我们随机分配到VISION模型或增强照常治疗(eTAU)。VISION模型包括五个视频咨询,其中包括诊断澄清,心理教育(承认和合法化的症状),和简短的心理治疗。eTAU包括对初级保健实践团队进行有关DSM-5SSD概念的培训,以及针对其在初级保健中的治疗的当前指南建议。我们评估可行性作为6个月时的主要结果,衡量招聘效率,干预可接受性,和安全。
结果:招募效率体现在总招募率(每个筛选的数字随机化)为55%(51/92)和同意率(每个符合条件的数字随机化)为94%(51/54)。干预的可接受性很高,有98%(123/125)的视频咨询按计划进行。两组均未发生严重不良事件。
结论:针对接受初级护理的SSD患者的综合心理健康视频咨询视觉模型是可行的,可接受,和安全。该模型的潜在临床有效性应在验证性试验中进行评估,该试验将针对SSD患者的多方面方法直接应用于初级保健实践。
背景:试验方案已在德国临床试验注册中心注册(编号:DRKS00026075,https://www。drks.de).
OBJECTIVE: Symptoms of somatic symptom disorder (SSD) are one of the most common reasons for consultations in primary care. However, specialized psychological services are mostly unavailable. This pilot trial aimed to determine the feasibility, acceptability, and safety of the integrated mental health video consultations VISION model for patients with SSD in primary care.
METHODS: We conducted a parallel group, randomized controlled pilot trial involving fifty-one patients with SSD from ten primary care practices in Germany, who we randomized to the VISION model or enhanced treatment-as-usual (eTAU). The VISION model comprised five video consultations which featured diagnostic clarification, psychoeducation (acknowledging and legitimizing of symptoms), and brief psychological therapy. eTAU included training primary care practice teams on the DSM-5 concept of SSD and on current guideline recommendations for its treatment in primary care. We assessed feasibility as the primary outcome at 6-months, measuring efficiency of recruitment, intervention acceptability, and safety.
RESULTS: Recruitment was efficient reflected in an overall recruitment yield (number randomized per number screened) of 55% (51/92) and a consent rate (number randomized per number eligible) of 94% (51/54). Acceptability of the intervention was high with 98% (123/125) of the video consultations conducted as planned. No serious adverse events were reported in either group.
CONCLUSIONS: An integrated mental health video consultations VISION model for patients with SSD presenting to primary care is feasible, acceptable, and safe. Potential clinical effectiveness of the model should be evaluated in confirmatory trial implementing the multifaceted approach tailored to the individual patient with SSD directly into primary care practice.
BACKGROUND: The trial protocol was registered at German Clinical Trials Register (number: DRKS00026075, https://www.drks.de).