多中心、随机对照试验认知疗法预防有害遵从命令性幻觉。
A multi-centre, randomised controlled trial of cognitive therapy to prevent harmful compliance with command hallucinations.
机构信息
School of Psychology, University of Birmingham, Edgbaston, B15 2TT, Birmingham, UK.
出版信息
BMC Psychiatry. 2011 Sep 30;11:155. doi: 10.1186/1471-244X-11-155.
BACKGROUND
Command hallucinations are among the most distressing, high risk and treatment resistant symptoms for people with psychosis; however, currently, there are no evidence-based treatment options available for this group. A cognitive therapy grounded in the principles of the Social Rank Theory, is being evaluated in terms of its effectiveness in reducing harmful compliance with command hallucinations.
METHODS/DESIGN: This is a single blind, intention-to-treat, multi-centre, randomized controlled trial comparing Cognitive Therapy for Command Hallucinations + Treatment as Usual with Treatment as Usual alone. Eligible participants have to fulfil the following inclusion criteria: i) ≥16 years; ii) ICD-10 diagnosis of schizophrenia or related disorder; iii) command hallucinations for at least 6 months leading to risk of harm to self or others. Following the completion of baseline assessments, eligible participants will be randomly allocated to either the Cognitive Therapy for Command Hallucinations + Treatment as Usual group or the Treatment as Usual group. Outcome will be assessed at 9 and 18 months post randomization with assessors blind to treatment allocation. The primary outcome is compliance behaviour and secondary outcomes include beliefs about voices' power, distress, psychotic symptoms together with a health economic evaluation. Qualitative interviews with services users will explore the acceptability of Cognitive Therapy for Command Hallucinations.
DISCUSSION
Cognitive behaviour therapy is recommended for people with psychosis; however, its focus and evaluation has primarily revolved around the reduction of psychotic symptoms. In this trial, however, the focus of the cognitive behavioural intervention is on individuals' appraisals, behaviour and affect and not necessarily symptoms; this is also reflected in the outcome measures used. If successful, the results will mark a significant breakthrough in the evidence base for service users and clinicians and will provide a treatment option for this group where none currently exist. The trial will open the way for further breakthrough work with the 'high risk' population of individuals with psychosis, which we would intend to pursue.
TRIAL REGISTRATION
ISRCTN: ISRCTN62304114.
背景
命令性幻听是精神分裂症患者最痛苦、风险最高且最难治疗的症状之一；然而，目前针对这一群体尚无循证治疗选择。一种基于社会等级理论原则的认知疗法，正在评估其降低有害性遵从命令性幻听的效果。
方法/设计：这是一项单盲、意向治疗、多中心、随机对照试验，比较认知疗法治疗命令性幻听+常规治疗与常规治疗。符合条件的参与者必须符合以下纳入标准：i）年龄≥16 岁；ii）ICD-10 诊断为精神分裂症或相关障碍；iii）命令性幻听至少 6 个月，导致自我或他人受伤的风险。完成基线评估后，符合条件的参与者将被随机分配到认知疗法治疗命令性幻听+常规治疗组或常规治疗组。在随机分组后 9 个月和 18 个月进行评估，评估人员对治疗分配情况不知情。主要结局是遵从行为，次要结局包括对声音力量的信念、痛苦、精神病症状以及健康经济评估。对服务使用者进行定性访谈，探讨认知疗法治疗命令性幻听的可接受性。
讨论
认知行为疗法推荐用于精神分裂症患者；然而，其重点和评估主要围绕减少精神病症状。然而，在这项试验中，认知行为干预的重点是个人的评估、行为和情感，而不一定是症状；这也反映在使用的结局指标上。如果成功，结果将为服务使用者和临床医生的证据基础带来重大突破，并为这一群体提供目前不存在的治疗选择。该试验将为精神分裂症高危人群的进一步突破性工作开辟道路，我们打算继续进行。
试验注册
ISRCTN：ISRCTN62304114。
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