Pragmatic randomised controlled trial of guided self-help versus individual cognitive behavioural therapy with a trauma focus for post-traumatic stress disorder (RAPID).

IF 3.5 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES
Jonathan I Bisson, Cono Ariti, Katherine Cullen, Neil Kitchiner, Catrin Lewis, Neil P Roberts, Natalie Simon, Kim Smallman, Katy Addison, Vicky Bell, Lucy Brookes-Howell, Sarah Cosgrove, Anke Ehlers, Deborah Fitzsimmons, Paula Foscarini-Craggs, Shaun R S Harris, Mark Kelson, Karina Lovell, Maureen McKenna, Rachel McNamara, Claire Nollett, Tim Pickles, Rhys Williams-Thomas
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引用次数: 0

Abstract

Background: 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.

Objective: 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.

Design: 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.

Setting: Primary and secondary mental health settings across the United Kingdom's National Health Service.

Participants: 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.

Interventions: 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.

Main outcome measures: 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.

Results: 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.

Limitations: The results are not generalisable to people with post-traumatic stress disorder to more than one traumatic event.

Conclusions: 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.

Future work: Work is now needed to determine how best to effectively disseminate and implement guided self-help using Spring at scale.

Trial registration: This trial is registered as ISRCTN13697710.

Funding: 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.

引导自助与个体认知行为治疗创伤后应激障碍(RAPID)的实用随机对照试验。
背景:引导式自助已被证明对其他精神疾病有效,如果对创伤后应激障碍有效,将提供一种时间效率高、容易获得的治疗选择,有可能减少等待时间和成本。目的:确定以创伤为重点的引导自助是否优于个体,面对面的以创伤为重点的认知行为疗法,用于轻度至中度创伤后应激障碍到单一创伤事件。设计:多中心实用随机对照非劣效性试验,采用经济评价来确定成本效益,采用嵌套过程评价来评估保真度和依从性、剂量和影响结果的因素(包括环境、可接受性、促进因素和障碍,定性测量)。参与者按1:1的比例随机分组。初步分析采用多水平协方差分析进行治疗。环境:英国国家卫生服务机构的初级和二级精神卫生机构。参与者:196名初步诊断为轻中度创伤后应激障碍的成年人被随机分组,在16周时保留82%,在52周时保留71%。对19名参与者和10名治疗师进行了过程评估。干预措施:多达12个面对面的、手动的、个人的、以创伤为重点的认知行为治疗疗程,每次疗程持续60-90分钟,或者使用Spring的指导自助,这是一个基于以创伤为重点的认知行为治疗的八步在线指导自助计划,最多5次面对面的会议,总共不超过3小时,会议之间有4次简短的电话或电子邮件联系。主要结果测量:主要结果:随机化后16周,临床应用的精神障碍诊断与统计手册PTSD量表,第五版。次要结局:包括52周时创伤后应激障碍症状的严重程度,随机化后16周和52周时功能、抑郁症状、焦虑症状、酒精使用和感知的社会支持。评估结果的人对分组分配不知情。结果:在《精神障碍诊断与统计手册第五版临床应用PTSD量表》16周的主要终点显示非劣效性[平均差异1.01(单侧95% CI -∞至3.90,非劣效性p = 0.012)]。临床医生管理的精神障碍诊断与统计手册PTSD量表,第五版,在52周时,两组的评分改善均保持在60%以上,但在该时间点,非劣效性结果不支持以创伤为重点的认知行为疗法[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生命年、增加质量调整生命年-0.04(95%置信区间-0.10至0.01)和使用Spring的指导自助方面没有显著差异,但使用Spring的指导自助的成本明显更低[277英镑(95%置信区间为253英镑至301英镑)对729英镑(95%置信区间为671英镑至788英镑)]。使用Spring的引导自助似乎是可以接受的,并且被参与者很好地容忍。没有发现重要的不良事件或副作用。局限性:研究结果不适用于创伤后应激障碍患者的创伤性事件。结论:引导自助使用Spring治疗轻度至中度创伤后应激障碍到单一创伤事件似乎不逊色于以创伤为焦点的个体面对面认知行为疗法,结果表明它应该被认为是这种情况下的一线治疗方法。未来的工作:现在需要确定如何最有效地传播和大规模地使用Spring实现引导自助。试验注册:该试验注册号为ISRCTN13697710。资助:该奖项由美国国家卫生与保健研究所(NIHR)卫生技术评估项目(NIHR奖励编号:14/192/97)资助,全文发表在《卫生技术评估》上;第27卷,第26号有关进一步的奖励信息,请参阅美国国立卫生研究院资助和奖励网站。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Health technology assessment
Health technology assessment 医学-卫生保健
CiteScore
6.90
自引率
0.00%
发文量
94
审稿时长
>12 weeks
期刊介绍: Health Technology Assessment (HTA) publishes research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS.
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