Centre for Applied Autism Research, Department of Psychology, Faculty of Humanities and Social Sciences, University of Bath, Bath, UK.
Bristol Randomised Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Health Technol Assess. 2019 Dec;23(68):1-94. doi: 10.3310/hta23680.
Co-occurring depression frequently occurs in autism. Evidence-based psychological interventions have been successfully adapted to treat co-occurring anxiety, but there is little evidence about the usefulness of adapted cognitive-behavioural therapy for depression. To the authors' knowledge, to date there have been no randomised trials investigating the usefulness of low-intensity cognitive-behavioural therapy for depression in autism.
The objectives of the study were to (1) develop a low-intensity psychological intervention for depression adapted for autism, (2) assess the feasibility and patient and therapist acceptability of the intervention, (3) estimate the rates of recruitment and retention for a full-scale randomised controlled trial and (4) identify an appropriate measure of depression to be used in a full-scale randomised controlled trial.
The study comprised a randomised controlled trial ( = 70) with a nested qualitative evaluation ( = 21). Seventy eligible and consenting participants were randomly allocated to guided self-help or to treatment as usual.
Adult autism services in two NHS regions.
Adults with a diagnosis of autism spectrum disorder with depression, that is, a Patient Health Questionnaire-9 items score of ≥ 10. People who had attended more than six sessions of cognitive-behavioural therapy in the previous 6 months were excluded.
The low-intensity intervention (guided self-help) comprised materials for nine individual sessions, based on behavioural activation adapted for autism, facilitated by therapist guides (coaches) who were graduate-level psychologists who attended training and regular supervision. Treatment as usual was standard NHS care for depression.
Outcomes were measured 10, 16 and 24 weeks post randomisation using self-report and interview measures of depression, anxiety, obsessive-compulsive symptoms, social function and quality of life, and a health-care and service use questionnaire. As this was a feasibility study also designed to identify the most appropriate measure of depression, it was not possible to specify the primary outcome measure or outcome point a priori.
The aims of the study were met in full. The guided self-help intervention was feasible and well received by participants and coaches. The majority of allocated participants attended the intervention in full. The most practical outcome point was determined to be 16 weeks. There were differential rates of attrition across the treatment groups: 86% of the guided self-help group remained in the study at 24 weeks, compared with 54% of treatment as usual group. The qualitative study suggested that guided self-help had enhanced credibility with participants at the point of randomisation. Inter-rater reliability of the interview measure of depression was less than adequate, limiting the conclusions that can be drawn from the prespecified sensitivity to change analyses.
The intervention was feasible and well received. Although this feasibility study was not a fully powered trial, it provided some evidence that the guided self-help intervention was effective in reducing depressive symptoms. A full-scale clinical effectiveness and cost-effectiveness trial of the intervention is warranted.
Improvements to the intervention materials as a result of qualitative interviews. Stakeholder consultation to consider future trial design, consider strategies to improve retention in a treatment as usual arm and select a self-report measure of depression to serve as the primary outcome measure.
Current Controlled Trials ISRCTN54650760.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 23, No. 68. See the NIHR Journals Library website for further project information. This study was also supported by the NIHR Biomedical Research Centre at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol.
自闭症患者常同时患有抑郁症。已成功将循证心理干预措施应用于治疗共病焦虑,但关于适应认知行为疗法治疗抑郁症的有效性的证据却很少。据作者所知,迄今为止,尚无随机试验研究针对自闭症患者的低强度认知行为疗法治疗抑郁症的有效性。
本研究的目的是(1)为自闭症患者开发一种低强度的心理干预措施,(2)评估干预措施的可行性以及患者和治疗师的可接受性,(3)估计全规模随机对照试验的招募和保留率,以及(4)确定适用于全规模随机对照试验的抑郁测量方法。
这是一项包含随机对照试验( = 70)和嵌套定性评估( = 21)的研究。70 名符合条件并同意参与的参与者被随机分配到指导自助或常规治疗组。
两个 NHS 地区的成人自闭症服务机构。
被诊断为自闭症谱系障碍并伴有抑郁症的成年人,即患者健康问卷-9 项得分≥ 10 分。在过去 6 个月内接受过超过 6 次认知行为疗法的人被排除在外。
低强度干预(指导自助)包括根据行为激活改编的九次个人辅导材料,由经过培训和定期监督的研究生水平心理学家担任治疗师指导(教练)。常规治疗为自闭症患者提供的标准 NHS 护理。
在随机分组后 10、16 和 24 周使用自我报告和访谈的抑郁、焦虑、强迫症状、社会功能和生活质量以及医疗保健和服务使用问卷来测量结果。由于这是一项旨在确定最适当的抑郁测量方法的可行性研究,因此不可能事先指定主要结果测量方法或结果点。
该研究的目标全部实现。指导自助干预措施具有可行性,且受到参与者和教练的欢迎。大多数分配的参与者完成了全部干预措施。最实用的结果测量点被确定为 16 周。治疗组的失访率存在差异:在 24 周时,指导自助组的 86%的参与者仍在研究中,而常规治疗组的 54%。定性研究表明,指导自助在随机分组时增强了参与者的可信度。抑郁访谈测量的组内信度不足,限制了从预先规定的敏感性分析中得出的结论。
干预措施具有可行性,且深受欢迎。尽管这项可行性研究不是一项完全有力的试验,但它提供了一些证据表明,指导自助干预措施在减轻抑郁症状方面是有效的。该干预措施的全规模临床有效性和成本效益试验是必要的。
对定性访谈进行干预措施材料的改进。利益相关者咨询以考虑未来的试验设计、考虑提高常规治疗组保留率的策略以及选择用于作为主要结果测量方法的抑郁自评量表。
当前对照试验 ISRCTN54650760。
该项目由英国国家卫生研究院(NIHR)健康技术评估计划资助,将在;第 23 卷,第 68 期。有关该项目的更多信息,请访问 NIHR 期刊库网站。该研究还得到了英国国家健康研究所(NIHR)布里斯托大学医院 NHS 基金会信托基金的生物医学研究中心以及布里斯托大学的支持。