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Low-intensity cognitive-behaviour therapy interventions for obsessive-compulsive disorder compared to waiting list for therapist-led cognitive-behaviour therapy: 3-arm randomised controlled trial of clinical effectiveness

机译:与治疗师主导的认知行为治疗的等待名单相比,强迫症的低强度认知行为治疗干预措施:3项临床有效性随机对照试验

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摘要

Background Obsessive-compulsive disorder (OCD) is prevalent and without adequate treatment usually follows a chronic course. “High-intensity” cognitive-behaviour therapy (CBT) from a specialist therapist is current “best practice.” However, access is difficult because of limited numbers of therapists and because of the disabling effects of OCD symptoms. There is a potential role for “low-intensity” interventions as part of a stepped care model. Low-intensity interventions (written or web-based materials with limited therapist support) can be provided remotely, which has the potential to increase access. However, current evidence concerning low-intensity interventions is insufficient. We aimed to determine the clinical effectiveness of 2 forms of low-intensity CBT prior to high-intensity CBT, in adults meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for OCD. Methods and findings This study was approved by the National Research Ethics Service Committee North West–Lancaster (reference number 11/NW/0276). All participants provided informed consent to take part in the trial. We conducted a 3-arm, multicentre randomised controlled trial in primary- and secondary-care United Kingdom mental health services. All patients were on a waiting list for therapist-led CBT (treatment as usual). Four hundred and seventy-three eligible patients were recruited and randomised. Patients had a median age of 33 years, and 60% were female. The majority were experiencing severe OCD. Patients received 1 of 2 low-intensity interventions: computerised CBT (cCBT; web-based CBT materials and limited telephone support) through “OCFighter” or guided self-help (written CBT materials with limited telephone or face-to-face support). Primary comparisons concerned OCD symptoms, measured using the Yale-Brown Obsessive Compulsive Scale–Observer-Rated (Y-BOCS-OR) at 3, 6, and 12 months. Secondary outcomes included health-related quality of life, depression, anxiety, and functioning. At 3 months, guided self-help demonstrated modest benefits over the waiting list in reducing OCD symptoms (adjusted mean difference = −1.91, 95% CI −3.27 to −0.55). These effects did not reach a prespecified level of “clinically significant benefit.” cCBT did not demonstrate significant benefit (adjusted mean difference = −0.71, 95% CI −2.12 to 0.70). At 12 months, neither guided self-help nor cCBT led to differences in OCD symptoms. Early access to low-intensity interventions led to significant reductions in uptake of high-intensity CBT over 12 months; 86% of the patients allocated to the waiting list for high-intensity CBT started treatment by the end of the trial, compared to 62% in supported cCBT and 57% in guided self-help. These reductions did not compromise longer-term patient outcomes. Data suggested small differences in satisfaction at 3 months, with patients more satisfied with guided self-help than supported cCBT. A significant issue in the interpretation of the results concerns the level of access to high-intensity CBT before the primary outcome assessment. Conclusions We have demonstrated that providing low-intensity interventions does not lead to clinically significant benefits but may reduce uptake of therapist-led CBT.
机译:背景强迫症(OCD)普遍存在,未经适当的治疗通常会在慢性病程中发生。专业治疗师的“高强度”认知行为疗法(CBT)是当前的“最佳实践”。但是,由于治疗师的数量有限以及OCD症状的致残作用,很难获得药物。作为分级护理模型的一部分,“低强度”干预措施可能具有潜在作用。可以远程提供低强度干预措施(治疗师支持有限的书面或基于Web的材料),这可能会增加访问权限。但是,目前有关低强度干预措施的证据不足。我们旨在确定在满足OCD精神病诊断和统计手册第四版(DSM-IV)标准的成年人中,在高强度CBT之前先进行两种形式的低强度CBT的临床疗效。方法和研究结果本研究得到美国国家研究伦理服务委员会西北-兰卡斯特的批准(参考号11 / NW / 0276)。所有参与者均提供了知情同意以参加试验。我们在英国的初级和二级医疗机构进行了一项三臂,多中心的随机对照试验。所有患者都在等待治疗师领导的CBT(照常治疗)的名单上。招募了473名合格患者并随机分组。患者中位年龄为33岁,其中60%为女性。大多数人经历了严重的强迫症。患者接受了2种低强度干预措施中的1种:通过“ OCFighter”或指导性自助服务(具有有限电话或面对面支持的书面CBT材料)进行的计算机CBT(cCBT;基于Web的CBT材料和有限的电话支持)。主要比较涉及强迫症症状,这些症状在3、6和12个月时使用耶鲁-布朗强迫症量表-观察者评定(Y-BOCS-OR)进行测量。次要结果包括与健康有关的生活质量,抑郁,焦虑和功能。在三个月的时间里,有指导的自助表现出比等待清单明显的减轻OCD症状的好处(调整后的平均差异= -1.91,95%CI -3.27至-0.55)。这些效果未达到“临床显着获益”的预定水平。 cCBT并未显示出明显的获益(调整后的平均差异= -0.71,95%CI -2.12至0.70)。在12个月时,引导式自助和cCBT均未导致OCD症状的差异。尽早使用低强度干预措施可以在12个月内显着降低高强度CBT的吸收;分配到高强度CBT等待名单中的患者中有86%在试验结束时开始治疗,相比之下,支持cCBT的患者为62%,引导式自助的患者为57%。这些减少并不影响患者的长期预后。数据表明,三个月的满意度差异很小,患者对指导性自助的满意度高于支持性cCBT。结果解释中的一个重要问题涉及在主要结果评估之前获得高强度CBT的水平。结论我们已经证明,提供低强度干预措施不会带来临床上的显着益处,但可能会减少治疗师主导的CBT的摄入。

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