Effects of cognitive behaviour therapy for worry on persecutory delusions in patients with psychosis (WIT): a parallel, single-blind, randomised controlled trial with a mediation analysis.
Effects of cognitive behaviour therapy for worry on persecutory delusions in patients with psychosis (WIT): a parallel, single-blind, randomised controlled trial with a mediation analysis.
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DOI：
10.1016/s2215-0366(15)00039-5
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发表时间：
2015-04
期刊：
影响因子：
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通讯作者：
Kingdon D
中科院分区：
文献类型：
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作者：
Freeman D;Dunn G;Startup H;Pugh K;Cordwell J;Mander H;Černis E;Wingham G;Shirvell K;Kingdon D
焦虑可能是精神病患者发生被害妄想的一个原因。因此，我们假设，通过认知行为疗法（CBT）减少担忧会减少迫害妄想。在我们的两组、评估者设盲、随机对照试验（焦虑干预试验[WIT]）中，我们从两个中心招募了18-65岁的持续性迫害妄想但非情感性精神病患者：牛津健康国民健康服务（NHS）基金会信托基金（英国牛津）和南方健康NHS基金会信托基金（英国南安普顿）。参与者的关键入选标准是精神病症状评定量表（PSYRATS）评分至少为3分，表示当前存在迫害妄想;妄想持续至少3个月;临床诊断为精神分裂症，情感障碍或妄想障碍;以及临床显著水平的担忧。我们将符合条件的患者随机分配（1：1），使用随机排列的区组程序，区组大小可变，分为四个分层，在标准治疗的基础上进行为期8周的6次减少担忧的CBT干预（CBT干预组），或仅进行标准治疗（对照组）。评估者对患者分配不知情，并在第0周（基线）、第8周（治疗结束）和第24周随访时进行评估。主要结果是通过宾夕法尼亚州立大学焦虑问卷（PSWQ）测量的焦虑和通过精神病妄想量表测量的妄想;我们在意向治疗人群中进行了分析，并进行了计划的调解分析。本试验已在ISRCTN登记处注册（编号ISRCTN 23197625），并对新参与者关闭。从2011年11月1日到2013年9月9日，我们招募了150名合格的参与者，并将73名随机分配到CBT干预组，77名随机分配到对照组。143例患者（95%）提供了主要结局随访数据。与单独的标准治疗相比，在8周时，CBT干预显著减少了焦虑（平均差异6.35 [SE 1.56] PSWQ单位，95% CI 3.30 - 9.40; p<0.001）和迫害妄想（2.08 [SE 0.73] PSYRATS单位，95% CI 0.64 - 3.51; p= 0.005）。随访24周时仍保持下降趋势。中介变量分析表明，焦虑的变化占妄想变化的66%。在我们的研究期间，没有患者死亡或入住安全病房。注意到6起自杀企图（CBT干预组2起，对照组4起）和2起严重暴力事件（每组1起），但没有不良事件被认为与治疗或评估有关。据我们所知，这是第一个针对迫害妄想的大型审判。我们已经证明，针对担忧的短暂干预可以显着减少长期存在的妄想，尽管我们研究的局限性包括没有确定干预中的关键要素。我们的研究结果表明，担心可能会导致偏执狂，担心干预技术可能是一个有益的补充，以标准治疗精神病。疗效和机制评价计划，这是英国医学研究理事会和国家卫生研究所的合作伙伴关系。
Worry might be a contributory causal factor in the occurrence of persecutory delusions in patients with psychotic disorders. Therefore we postulated that reducing worry with cognitive behaviour therapy (CBT) would reduce persecutory delusions. For our two-arm, assessor-blinded, randomised controlled trial (Worry Intervention Trial [WIT]), we recruited patients aged 18–65 years with persistent persecutory delusions but non-affective psychosis from two centres: the Oxford Health National Health Service (NHS) Foundation Trust (Oxford, UK) and the Southern Health NHS Foundation Trust (Southampton, UK). The key inclusion criteria for participants were a score of at least 3 on the Psychotic Symptoms Rating Scale (PSYRATS) denoting a current persecutory delusion; that the delusion had persisted for at least 3 months; a clinical diagnosis of schizophrenia, schizoaffective disorder, or delusional disorder; and a clinically significant level of worry. We randomly assigned (1:1) eligible patients, using a randomly permuted block procedure with variable block sizes and division by four strata, to either six sessions of worry-reduction CBT intervention done over 8 weeks added to standard care (the CBT-intervention group), or to standard care alone (the control group). The assessors were masked to patient allocations and did their assessments at week 0 (baseline), 8 weeks (end of treatment), and 24 weeks, follow-up. The primary outcomes were worry measured by the Penn State Worry Questionnaire (PSWQ) and delusions measured by the PSYRATS-delusion scale; we did the analyses in the intention-to-treat population, and also did a planned mediation analysis. This trial is registered with the ISRCTN Registry (number ISRCTN23197625) and is closed to new participants. From Nov 1, 2011, to Sept 9, 2013, we recruited 150 eligible participants and randomly assigned 73 to the CBT intervention group, and 77 to the control group. 143 patients (95%) provided primary outcome follow-up data. Compared with standard care alone, at 8 weeks the CBT intervention significantly reduced worry (mean difference 6·35 [SE 1·56] PSWQ units, 95% CI 3·30–9·40; p<0·001) and persecutory delusions (2·08 [SE 0·73] PSYRATS units, 95% CI 0·64–3·51; p=0·005). The reductions were maintained to 24 weeks follow-up. The mediation analysis suggested that the change in worry accounted for 66% of the change in delusion. No patients died or were admitted to secure units during our study. Six suicide attempts (two in the CBT intervention group, and four in the control group) and two serious violent incidents (one in each group) were noted, but no adverse events were deemed related to the treatments or the assessments. To our knowledge, this is the first large trial focused on persecutory delusions. We have shown that long-standing delusions were significantly reduced by a brief intervention targeted on worry, although the limitations for our study include no determination of the key elements within the intervention. Our results suggest that worry might cause paranoia, and that worry intervention techniques might be a beneficial addition to the standard treatment of psychosis. Efficacy and Mechanism Evaluation programme, which is a UK Medical Research Council and National Institute of Health Research partnership.