Therapist-supported online cognitive therapy for post-traumatic stress disorder (PTSD) in young people: protocol for an early-stage, parallel-group, randomised controlled study (OPTYC trial).
Therapist-supported online cognitive therapy for post-traumatic stress disorder (PTSD) in young people: protocol for an early-stage, parallel-group, randomised controlled study (OPTYC trial).
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DOI：
10.1136/bmjopen-2021-054852
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发表时间：
2022-03-21
期刊：
影响因子：
2.9
通讯作者：
Meiser-Stedman R
中科院分区：
文献类型：
--
作者：
Smith P;Ehlers A;Carr E;Clark D;Dalgleish T;Forbes G;Goldsmith K;Griffiths H;Gupta M;King D;Miles S;Plant D;Yule W;Meiser-Stedman R
创伤后应激障碍（PTSD）是一种致残性精神疾病，影响到暴露于创伤事件的少数年轻人。针对创伤后应激障碍的有效面对面心理治疗是存在的。然而，大多数患有PTSD的年轻人没有接受循证治疗。远程交付的数字干预措施有可能显着改善治疗的可及性。数字干预已成功用于患有抑郁症和焦虑症的年轻人以及患有创伤后应激障碍的成年人。然而，治疗年轻人PTSD的数字干预措施尚未得到评估。青少年和照顾者的在线创伤后应激障碍治疗（OPTYC）试验将评估一种新型互联网认知疗法（iCT-PTSD-YP）治疗青少年创伤后应激障碍的可行性，可接受性和临床疗效的初步指征。本方案描述了一项双臂、平行组、单盲（结局评估者）、早期随机对照试验，比较了iCT-PTSD-YP与等待名单（WL）对照药物。将从伦敦和英格兰东南部的14个NHS儿童和青少年心理健康服务中心、同一地区的中学和初级保健中心或通过使用研究网站从英国任何地方自我转诊招募N=34名青少年（12-17岁），其主要问题是暴露于单一创伤事件后的PTSD。个体患者水平的随机化将以1：1的比例分配受试者，根据性别和基线症状严重程度使用最小化进行随机化。主要研究结果是关于可行性和可接受性的数据，包括招募、依从性、保留和不良事件（AE）。主要临床结局是随机分组后16周的PTSD诊断。次要临床结果包括持续测量PTSD、焦虑和抑郁症状。回归分析将提供iCT-PTSD-YP对PTSD诊断、PTSD症状、相对于WL的焦虑和抑郁的影响的初步估计。过程-结果评价将考虑哪些机制介导恢复。与年轻人，家庭和治疗师的定性访谈将评估可接受性。该研究获得了英国健康研究管理局研究伦理委员会的批准（19/LO/1354）。对于16岁以下的参与者，将由护理人员提供知情同意书，并征求年轻人的同意; 16岁或以上的参与者可以在没有父母或护理人员参与的情况下提供知情同意书。调查结果将广泛分发给参与者，医疗保健专业人员，公众和其他相关群体。研究结果将发表在同行评审期刊上。ISRCTN16876240。
Post-traumatic stress disorder (PTSD) is a disabling psychiatric condition that affects a significant minority of young people exposed to traumatic events. Effective face-to-face psychological treatments for PTSD exist. However, most young people with PTSD do not receive evidence-based treatment. Remotely delivered digital interventions have potential to significantly improve treatment accessibility. Digital interventions have been successfully employed for young people with depression and anxiety, and for adults with PTSD. However, digital interventions to treat PTSD in young people have not been evaluated. The Online PTSD Treatment for Young People & Carers (OPTYC) trial will evaluate the feasibility, acceptability and initial indications of clinical efficacy of a novel internet-delivered Cognitive Therapy for treatment of PTSD in young people (iCT-PTSD-YP). This protocol describes a two-arm, parallel-groups, single-blind (outcome assessor), early-stage randomised controlled trial, comparing iCT-PTSD-YP with a waiting list (WL) comparator. N=34 adolescents (12–17 years old), whose primary problem is PTSD after exposure to a single traumatic event, will be recruited from 14 NHS Child and Adolescent Mental Health Services in London and southeast England, from secondary schools and primary care in the same region, or via self-referral from anywhere in the UK using the study website. Individual patient-level randomisation will allocate participants in a 1:1 ratio, randomised using minimisation according to sex and baseline symptom severity. The primary study outcomes are data on feasibility and acceptability, including recruitment, adherence, retention and adverse events (AEs). The primary clinical outcome is PTSD diagnosis 16 weeks post-randomisation. Secondary clinical outcomes include continuous measures of PTSD, anxiety and depression symptoms. Regression analyses will provide preliminary estimates of the effect of iCT-PTSD-YP on PTSD diagnosis, symptoms of PTSD, anxiety and depression relative to WL. Process-outcome evaluation will consider which mechanisms mediate recovery. Qualitative interviews with young people, families and therapists will evaluate acceptability. The study was approved by a UK Health Research Authority Research Ethics Committee (19/LO/1354). For participants aged under 16, informed consent will be provided by carers and the young person will be asked for their assent; participants aged 16 years or older can provide informed consent without their parent or caregiver’s involvement. Findings will be disseminated broadly to participants, healthcare professionals, the public and other relevant groups. Study findings will be published in peer-reviewed journals. ISRCTN16876240.
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影响因子：
2.1
作者：
Meiser-Stedman, Richard;Smith, Patrick;Dalgleish, Tim
通讯作者：
Dalgleish, Tim
影响因子：
4.1
作者：
Ehlers, A;Clark, DM;Fennell, M
通讯作者：
Fennell, M
影响因子：
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作者：
Copeland, William E.;Keeler, Gordon;Costello, E. Jane
通讯作者：
Costello, E. Jane
影响因子：
1.9
作者：
Meiser-Stedman, Richard;Shepperd, Alicia;Smith, Patrick
通讯作者：
Smith, Patrick
影响因子：
3.8
作者：
Fritz MS;Taylor AB;Mackinnon DP
通讯作者：
Mackinnon DP