Centre for Mental Health, Imperial College London, London, UK.
Health Technol Assess. 2012;16(8):iii-iv, 1-76. doi: 10.3310/hta16080.
To examine the clinical effectiveness and cost-effectiveness of referral to group art therapy plus standard care, compared with referral to an activity group plus standard care and standard care alone, among people with schizophrenia.
A three-arm, parallel group, single-blind, pragmatic, randomised controlled trial. Participants were randomised via an independent and remote telephone randomisation service using permuted blocks, stratified by study centre.
Study participants were recruited from secondary care mental health and social services in four UK centres.
Potential participants were aged 18 years or over, had a clinical diagnosis of schizophrenia, confirmed by an examination of case notes, and provided written informed consent. We excluded those who were unable to speak sufficient English to complete the baseline assessment, those with severe cognitive impairment and those already receiving arts therapy.
Group art therapy was delivered by registered art therapists according to nationally agreed standards. Groups had up to eight members, lasted for 90 minutes and ran for 12 months. Members were given access to a range of art materials and encouraged to use these to express themselves freely. Activity groups were designed to control for the non-specific effects of group art therapy. Group facilitators offered various activities and encouraged participants to collectively select those they wanted to pursue. Standard care involved follow-up from secondary care mental health services and the option of referral to other services, except arts therapies, as required.
Our co-primary outcomes were global functioning (measured using the Global Assessment of Functioning Scale - GAF) and mental health symptoms (measured using the Positive and Negative Syndrome Scale - PANSS) at 24 months. The main secondary outcomes were level of group attendance, social functioning, well-being, health-related quality of life, service utilisation and other costs measured 12 and 24 months after randomisation.
Four hundred and seventeen people were recruited, of whom 355 (85%) were followed up at 2 years. Eighty-six (61%) of those randomised to art therapy and 73 (52%) of those randomised to activity groups attended at least one group. No differences in primary outcomes were found between the three study arms. The adjusted mean difference between art therapy and standard care at 24 months was -0.9 [95% confidence interval (CI) -3.8 to 2.1] on the GAF Scale and 0.7 (95% CI -3.1 to 4.6) on the PANSS Scale. Differences in secondary outcomes were not found, except that those referred to an activity group had fewer positive symptoms of schizophrenia at 24 months than those randomised to art therapy. Secondary analysis indicated that attendance at art therapy groups was not associated with improvements in global functioning or mental health. Although the total cost of the art therapy group was lower than the cost of the two comparison groups, referral to group art therapy did not appear to provide a cost-effective use of resources.
Referring people with established schizophrenia to group art therapy as delivered in this randomised trial does not appear to improve global functioning or mental health of patients or provide a more cost-effective use of resources than standard care alone.
Current Controlled Trials ISRCTN 46150447.
This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 8. See the HTA programme website for further project information.
研究与活动小组加标准护理组和标准护理组相比,将精神分裂症患者转介至团体艺术治疗加标准护理的临床效果和成本效益。
三臂、平行组、单盲、实用、随机对照试验。参与者通过独立的远程电话随机分配服务,使用置换块进行随机分组,按研究中心分层。
研究参与者从英国四个中心的二级保健心理健康和社会服务机构招募。
潜在参与者年龄在 18 岁或以上,有精神分裂症的临床诊断,通过病历检查得到证实,并提供书面知情同意书。我们排除了那些无法用足够的英语完成基线评估的人、那些有严重认知障碍的人和那些已经接受艺术治疗的人。
团体艺术治疗由注册艺术治疗师根据国家商定的标准提供。团体的成员人数最多为 8 人,持续 90 分钟,为期 12 个月。成员可以使用各种艺术材料,并被鼓励自由地表达自己。活动小组旨在控制团体艺术治疗的非特异性影响。小组主持人提供各种活动,并鼓励参与者集体选择他们想要从事的活动。标准护理包括从二级保健心理健康服务机构进行随访,并根据需要提供转介到其他服务(艺术治疗除外)的选择。
我们的共同主要结果是 24 个月时的总体功能(使用总体功能评估量表 - GAF)和心理健康症状(使用阳性和阴性综合征量表 - PANSS)。主要次要结果是团体出勤率、社会功能、幸福感、健康相关生活质量、服务利用和其他在随机分组后 12 个月和 24 个月测量的成本。
共招募了 417 人,其中 355 人(85%)在 2 年后进行了随访。随机分配到艺术治疗组的 86 人(61%)和随机分配到活动组的 73 人(52%)至少参加了一次小组活动。三组之间的主要结果没有差异。在 24 个月时,艺术治疗与标准护理之间的调整平均差异为 GAF 量表上的 -0.9 [95%置信区间(CI)-3.8 至 2.1],PANSS 量表上的 0.7 [95%CI -3.1 至 4.6]。没有发现次要结果的差异,除了被转介到活动组的人在 24 个月时的精神分裂症阳性症状比被转介到艺术治疗组的人少。二次分析表明,参加艺术治疗小组与总体功能或心理健康的改善无关。尽管艺术治疗小组的总成本低于两个对照组的成本,但转介到艺术治疗小组似乎并没有提供更具成本效益的资源利用。
在本随机试验中,将确诊为精神分裂症的患者转介至团体艺术治疗组似乎不会改善患者的总体功能或心理健康,也不会比单独的标准护理更具成本效益。
当前对照试验 ISRCTN 46150447。
该项目由英国国家卫生与保健优化研究所的健康技术评估计划资助,将在《健康技术评估》杂志上全文发表;第 16 卷,第 8 期。有关该项目的更多信息,请访问 HTA 计划网站。