Eilenberg Trine
Dan Med J. 2016 Oct;63(10).
Health anxiety is prevalent (5-9%) in all healthcare settings and in the general population, may have an early onset, and a poor prognosis is seen in severe cases if untreated. Research shows that health anxiety is rarely diagnosed though it causes great suffering for the individual and constitutes a substantial socio-economic burden. Studies have shown that individual cognitive behavioural therapy can relieve health anxiety, but these studies are affected by methodological problems, among others, struggling with patients declining participation, high dropout rates, and some patients not responding to the treatment. Moreover, the impact of health anxiety on sick leave is only scarcely examined. This thesis examines the effect of a new treatment approach, group-based Acceptance & Commitment Therapy (ACT-G) for patients with severe health anxiety in an uncontrolled pilot study and a randomised controlled study (RCT) on ACT-G compared with a 10-month waitlist control condition (paper I and II). Also, the thesis comprises a study on sick leave in patients with health anxiety compared with the general population during a 5-year period and the effect of ACT-G on sick leave. The findings from this study are described in paper III. Patients (age 20-60 years) consecutively referred from general practitioners from Jutland and Funen in the period of March 2010 - April 2012 (approx. 2.5 million citizens) to the Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, were included. The pilot study included 34 patients, the RCT on ACT-G included 126 patients. In the RCT, patients were block-randomised to either ACT-G and received treatment in 7 groups of each 9 patients in the period of December 2010 - October 2012, or to a 10-month waitlist control group. The primary outcome measure was the Whiteley-7 paper and pencil index for illness worrying. The last paper is based on data on sickness-related benefits from the DREAM social register of transfer benefits and also includes a matched general population register control cohort (n=12,600). In this thesis, we wish to answer the following questions: 1) Is ACT-G an acceptable, feasible and effective treatment approach for patients with severe health anxiety? 2) Can ACT-G improve severe illness worry compared with a waitlist control condition, and are the recently introduced diagnostic criteria for health anxiety acceptable for the patients? 3) Do patients with health anxiety show more sick leave than the general population during a 5-year period, and can ACT-G reduce sick leave measured by transfer benefits (weeks on sickness-related benefits) at 1-year follow-up? As ACT has not previously been examined as treatment approach for health anxiety, we initially conducted an uncontrolled pilot study to test the newly developed manualised program (ACT-G). The study included 34 patients with severe health anxiety and showed very low dropout and high treatment satisfaction. Significant improvements in self-reported illness worry were demonstrated post-treatment, and the results were sustained and further improved at 3- and 6-months follow-up compared to baseline. The subsequent RCT found high acceptance of the diagnosis of health anxiety. All patients (except 1) accepted the diagnosis as the right diagnosis to fit their ailment, and the majority of the patients found that the diagnosis helped them to better understand their symptoms. In an intention-to-treat analysis, ACT-G showed significant effect in the improvement of self-reported illness worry and other secondary measures compared with a waitlist control condition, both post-treatment and at 10-month follow-up (6 months post-treatment). The results were considered clinically significant as 2/3 of the patients in ACT-G at follow-up had demonstrated a pre-defined treatment response, and ¼ of the patients were considered to no longer have clinical case status. Furthermore, the number needed to treat was found to be 2.4. Patients with severe health anxiety showed significantly more weeks on sickness-related benefits than matched individuals from the general population during the 5 years prior to entering the RCT. This difference was stable until an estimated cut-point at 1 year before enrolment, where patients with health anxiety showed further increase in sickness-related-benefits. At one-year follow-up (8 months post-treatment), we did not find a significant difference between ACT-G and the waitlist group in weeks on sickness-related benefits. Post-hoc analysis, however, revealed a significant decrease in weeks on sickness-related benefits for ACT-G during the 2 years after randomisation. In conclusion, the thesis suggests that ACT-G is both an acceptable and effective treatment approach for patients with severe health anxiety. Hopefully, these findings can contribute to the future research and identification of which treatment approaches are the most effective and for which patients and contribute to tailored, early interventions. This may possibly prevent development of otherwise chronic symptoms, increase the quality of life for the patients, and potentially reduce socio-economic costs.
健康焦虑在所有医疗环境和普通人群中都很普遍(5%-9%),可能起病较早,若不治疗,严重病例的预后较差。研究表明,尽管健康焦虑给个体带来巨大痛苦并构成相当大的社会经济负担,但却很少得到诊断。研究表明,个体认知行为疗法可以缓解健康焦虑,但这些研究受到方法学问题的影响,比如患者拒绝参与、高脱落率以及一些患者对治疗无反应等。此外,健康焦虑对病假的影响几乎未被研究。本论文在一项非对照试验性研究以及一项将基于团体的接纳与承诺疗法(ACT-G)与为期10个月的等待名单对照条件进行比较的随机对照试验(RCT)中,研究了这种新的治疗方法对严重健康焦虑患者的效果(论文一和论文二)。此外,本论文还包括一项关于健康焦虑患者与普通人群在5年期间病假情况的研究以及ACT-G对病假的影响。该研究的结果在论文三中进行了描述。纳入了2010年3月至2012年4月期间(约250万公民)从日德兰半岛和菲英岛的全科医生处连续转诊至奥胡斯大学医院功能障碍与身心医学研究诊所的患者(年龄20 - 60岁)。试验性研究纳入了34名患者,ACT-G的随机对照试验纳入了126名患者。在随机对照试验中,患者被整群随机分配到ACT-G组,并于2010年12月至2012年10月期间分7组每组9名患者接受治疗,或者分配到为期10个月的等待名单对照组。主要结局指标是用于疾病担忧的惠特利-7纸笔指数。最后一篇论文基于来自DREAM社会转移福利登记册中与疾病相关福利的数据,并且还包括一个匹配的普通人群登记对照队列(n = 12600)。在本论文中,我们希望回答以下问题:1)ACT-G对严重健康焦虑患者而言是否是一种可接受、可行且有效的治疗方法?2)与等待名单对照条件相比,ACT-G能否改善严重的疾病担忧,以及最近引入的健康焦虑诊断标准对患者来说是否可接受?3)健康焦虑患者在5年期间的病假天数是否比普通人群更多,以及ACT-G能否在1年随访时通过转移福利(与疾病相关福利的周数)减少病假天数?由于之前尚未将ACT作为健康焦虑的治疗方法进行研究,我们首先进行了一项非对照试验性研究,以测试新开发的手册化方案(ACT-G)。该研究纳入了34名严重健康焦虑患者,结果显示脱落率极低且治疗满意度高。治疗后自我报告的疾病担忧有显著改善,与基线相比,在3个月和6个月随访时结果得以维持并进一步改善。随后的随机对照试验发现患者对健康焦虑诊断的接受度很高。所有患者(除1名外)都认为该诊断是适合其疾病的正确诊断,并且大多数患者发现该诊断有助于他们更好地理解自己的症状。在意向性分析中,与等待名单对照条件相比,ACT-G在治疗后以及10个月随访(治疗后6个月)时,在改善自我报告的疾病担忧和其他次要指标方面显示出显著效果。这些结果被认为具有临床意义,因为在随访时ACT-G组中2/3的患者表现出了预先定义的治疗反应,并且1/4的患者被认为不再处于临床病例状态。此外,发现治疗所需人数为2.4。在进入随机对照试验之前的5年里,严重健康焦虑患者与普通人群中匹配个体相比,领取与疾病相关福利的周数显著更多。这种差异一直稳定,直到入组前估计的一个切点,此时健康焦虑患者领取与疾病相关福利的周数进一步增加。在1年随访时(治疗后8个月),我们未发现ACT-G组与等待名单组在领取与疾病相关福利的周数上有显著差异。然而,事后分析显示,随机分组后2年期间ACT-G组领取与疾病相关福利的周数显著减少。总之,本论文表明ACT-G对严重健康焦虑患者而言既是一种可接受的也是有效的治疗方法。希望这些发现能够为未来的研究以及确定哪些治疗方法对哪些患者最有效做出贡献,并有助于进行有针对性的早期干预。这可能会防止原本会发展为慢性症状的情况,提高患者的生活质量,并有可能降低社会经济成本。