■引导式自助已被证明对其他精神状态有效,如果对创伤后应激障碍有效,将提供一种省时和可获得的治疗选择,有可能减少等待时间和成本。
■为了确定以创伤为中心的指导自助是否不劣于个人,以创伤为重点的面对面认知行为疗法,用于轻度至中度创伤后应激障碍至单一创伤事件。
■多中心语用随机对照非劣效性试验,经济评估以确定成本效益,嵌套过程评估以评估忠诚度和依从性,剂量和影响结果的因素(包括环境,可接受性,促进者和障碍,定性测量)。参与者以1:1的比例随机分组。主要分析是使用多水平协方差分析进行治疗。
■英国国家卫生服务的主要和次要心理健康设置。
■初步诊断为轻度至中度创伤后应激障碍的一百九十六位成年人被随机分组,16周时有82%的滞留率,52周时有71%的滞留率。对19名参与者和10名治疗师进行了过程评估。
■最多12个面对面,手工,以创伤为焦点的个体认知行为治疗,每次持续60-90分钟,或者使用Spring引导自助,基于创伤焦点的认知行为疗法的八步在线指导自助计划,最多举行五次总计3小时的面对面会议,两次会议之间有四次简短的电话或电子邮件联系。
■主要结果:精神障碍诊断和统计手册的临床医师管理的PTSD量表,第五版,随机化后16周。次要结果:包括52周时创伤后应激障碍症状的严重程度,和功能,抑郁症的症状,焦虑的症状,随机分组后16周和52周的饮酒和感知的社会支持。那些评估结果的人对小组分配视而不见。
■在16周的主要终点,在《精神障碍诊断和统计手册的临床医师管理的PTSD量表》中证明了非劣效性,第五版[平均差1.01(单侧95%CI-∞至3.90,非劣效性p=0.012)]。临床医师管理的PTSD量表,用于精神疾病诊断和统计手册,第五版,在52周时,两组的评分均保持了60%以上的改善,但非劣效性结果没有定论,支持在该时间点出现创伤病灶的认知行为治疗[平均差异3.20(单侧95%置信区间-∞至6.00,非劣效性p=0.15)].尽管在累积质量调整的生命年中没有显着差异,但使用Spring进行的引导式自助并未显示出比具有创伤重点的面对面认知行为疗法更具成本效益。增量质量调整生命年-0.04(95%置信区间-0.10至0.01)和使用Spring的指导自助服务的成本明显更低[277英镑(95%置信区间253英镑至301英镑)与729英镑(95%CI671英镑至788英镑)]。使用Spring进行的引导式自助似乎是参与者可以接受和容忍的。没有发现重要的不良事件或副作用。
■这些结果对于患有创伤后应激障碍的人来说并不能推广到一个以上的创伤事件。
■使用Spring对轻度至中度创伤后应激障碍进行单一创伤事件的指导自助似乎不劣于以创伤为重点的个人面对面认知行为疗法,结果表明,对于患有这种疾病的人,应将其视为一线治疗。
■现在需要开展工作,以确定如何在规模上有效地传播和实施指导式自助。
■本试验注册为ISRCTN13697710。
■该奖项由美国国家卫生与护理研究所(NIHR)卫生技术评估计划(NIHR奖参考:14/192/97)资助,并在《卫生技术评估》中全文发布。27号26.有关更多奖项信息,请参阅NIHR资助和奖励网站。
创伤后应激障碍是一种常见的,严重创伤事件后可能发生的致残状况。典型的症状包括痛苦的恢复,避免提醒和感觉当前的威胁感。创伤后应激障碍的首选治疗方法是个人的,面对面交谈治疗,12-16小时的持续时间,包括以创伤为焦点的认知行为疗法。如果可以开发出同样有效的治疗方法,花费更少的时间,并且可以在家中以灵活的方式进行,这将提高可访问性,减少等待时间,从而减少疾病负担。RAPID是一项使用名为Spring的基于网络的程序的随机对照试验。目的是确定以创伤为中心的指导自助是否比首选面对面治疗为创伤后应激障碍提供了更快,更便宜的治疗方法,同时同样有效。使用Spring的引导自助通过八个步骤交付。治疗师提供了一个1小时的介绍性会议,然后是另外四个,每两周30分钟的会议和四个简短(约5分钟)的电话或电子邮件联系会话。在每届会议上,治疗师审查进展并指导客户完成该计划,提供持续的支持,监测,动机和解决问题。一百九十六位患有创伤后应激障碍的人参加了这项研究。发现使用Spring进行的有指导的自助在减少16周时的创伤后应激障碍症状方面与首选面对面治疗同样有效。两组在随机分组后52周均保持了非常明显的改善,大多数结果尚无定论,但赞成面对面治疗。使用Spring进行的有指导的自助服务要便宜得多,而且似乎耐受性良好。值得注意的是,并不是每个人都受益于使用Spring的指导自助,强调了逐个考虑的重要性,和个性化干预。但是,RAPID试验表明,使用Spring的指导自助为创伤后应激障碍患者提供了一种低强度治疗选择,该选择已准备在国家卫生服务中实施.
UNASSIGNED: Guided self-help has been shown to be effective for other mental conditions and, if effective for post-traumatic stress disorder, would offer a time-efficient and accessible treatment option, with the potential to reduce waiting times and costs.
UNASSIGNED: To determine if trauma-focused guided self-help is non-inferior to individual, face-to-face cognitive-behavioural therapy with a trauma focus for mild to moderate post-traumatic stress disorder to a single traumatic event.
UNASSIGNED: Multicentre pragmatic randomised controlled non-inferiority
trial with economic evaluation to determine cost-effectiveness and nested process evaluation to assess fidelity and adherence, dose and factors that influence outcome (including context, acceptability, facilitators and barriers, measured qualitatively). Participants were randomised in a 1 : 1 ratio. The primary analysis was intention to treat using multilevel analysis of covariance.
UNASSIGNED: Primary and secondary mental health settings across the United Kingdom\'s National Health Service.
UNASSIGNED: One hundred and ninety-six adults with a primary diagnosis of mild to moderate post-traumatic stress disorder were randomised with 82% retention at 16 weeks and 71% at 52 weeks. Nineteen participants and ten therapists were interviewed for the process evaluation.
UNASSIGNED: Up to 12 face-to-face, manualised, individual cognitive-behavioural therapy with a trauma focus sessions, each lasting 60-90 minutes, or to guided self-help using Spring, an eight-step online guided self-help programme based on cognitive-behavioural therapy with a trauma focus, with up to five face-to-face meetings of up to 3 hours in total and four brief telephone calls or e-mail contacts between sessions.
UNASSIGNED: Primary outcome: the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, at 16 weeks post-randomisation. Secondary outcomes: included severity of post-traumatic stress disorder symptoms at 52 weeks, and functioning, symptoms of depression, symptoms of anxiety, alcohol use and perceived social support at both 16 and 52 weeks post-randomisation. Those assessing outcomes were blinded to group assignment.
UNASSIGNED: Non-inferiority was demonstrated at the primary end point of 16 weeks on the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [mean difference 1.01 (one-sided 95% CI -∞ to 3.90, non-inferiority p = 0.012)]. Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, score improvements of over 60% in both groups were maintained at 52 weeks but the non-inferiority results were inconclusive in favour of cognitive-behavioural therapy with a trauma focus at this timepoint [mean difference 3.20 (one-sided 95% confidence interval -∞ to 6.00, non-inferiority p = 0.15)]. Guided self-help using Spring was not shown to be more cost-effective than face-to-face cognitive-behavioural therapy with a trauma focus although there was no significant difference in accruing quality-adjusted life-years, incremental quality-adjusted life-years -0.04 (95% confidence interval -0.10 to 0.01) and guided self-help using Spring was significantly cheaper to deliver [£277 (95% confidence interval £253 to £301) vs. £729 (95% CI £671 to £788)]. Guided self-help using Spring appeared to be acceptable and well tolerated by participants. No important adverse events or side effects were identified.
UNASSIGNED: The results are not generalisable to people with post-traumatic stress disorder to more than one traumatic event.
UNASSIGNED: Guided self-help using Spring for mild to moderate post-traumatic stress disorder to a single traumatic event appears to be non-inferior to individual face-to-face cognitive-behavioural therapy with a trauma focus and the results suggest it should be considered a first-line treatment for people with this condition.
UNASSIGNED: Work is now needed to determine how best to effectively disseminate and implement guided self-help using Spring at scale.
UNASSIGNED: This
trial is registered as ISRCTN13697710.
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/192/97) and is published in full in Health Technology Assessment; Vol. 27, No. 26. See the NIHR Funding and Awards website for further award information.
Post-traumatic stress disorder is a common, disabling condition that can occur following major traumatic events. Typical symptoms include distressing reliving, avoidance of reminders and feeling a current sense of threat. First-choice treatments for post-traumatic stress disorder are individual, face-to-face talking treatments, of 12–16 hours duration, including cognitive behavioural therapy with a trauma focus. If equally effective treatments could be developed that take less time and can be largely undertaken in a flexible manner at home, this would improve accessibility, reduce waiting times and hence the burden of disease. RAPID was a randomised controlled
trial using a web-based programme called Spring. The aim was to determine if trauma-focused guided self-help provided a faster and cheaper treatment for post-traumatic stress disorder than first-choice face-to-face therapy, while being equally effective. Guided self-help using Spring is delivered through eight steps. A therapist provides a 1-hour introductory meeting followed by four further, fortnightly sessions of 30 minutes each and four brief (around 5 minutes) telephone calls or e-mail contacts between sessions. At each session, the therapist reviews progress and guides the client through the programme, offering continued support, monitoring, motivation and problem-solving. One hundred and ninety-six people with post-traumatic stress disorder to a single traumatic event took part in the
study. Guided self-help using Spring was found to be equally effective to first-choice face-to-face therapy at reducing post-traumatic stress disorder symptoms at 16 weeks. Very noticeable improvements were maintained at 52 weeks post-randomisation in both groups, when most results were inconclusive but in favour of face-to-face therapy. Guided self-help using Spring was significantly cheaper to deliver and appeared to be well-tolerated. It is noteworthy that not everyone benefitted from guided self-help using Spring, highlighting the importance of considering it on a person-by-person basis, and personalising interventions. But, the RAPID
trial has demonstrated that guided self-help using Spring provides a low-intensity treatment option for people with post-traumatic stress disorder that is ready to be implemented in the National Health Service.