Montero-Marin Jesus, Collado-Navarro Carlos, Navarro-Gil Mayte, Lopez-Montoyo Alba, Demarzo Marcelo, Herrera-Mercadal Paola, Barcelo-Soler Alberto, Garcia-Campayo Javier
Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain.
La Plana University Hospital, Castellón, Spain.
BMJ Open. 2019 Oct 8;9(10):e029909. doi: 10.1136/bmjopen-2019-029909.
Depressive, anxiety and adjustment disorders are highly prevalent among mental health outpatients. The lack of funding for mental health problems produces inefficient results and a high burden of disease. New cost-effective group interventions aimed at treating these symptoms might be an appropriate solution to reduce the healthcare burden in mental health units. Mindfulness-based interventions (MBIs) have shown significant reductions in anxious, depressive and adjustment symptomatology. Recent research highlights the influence of compassion as a key mechanism of change. However, MBIs only address compassion implicitly, whereas compassion-based protocols consider it a core aspect of psychotherapy. In this randomised controlled trial, we hypothesise that the provision of attachment-based compassion therapy (ABCT), which is a compassion-based protocol, will be more effective than mindfulness-based stress reduction (MBSR), which is a conventional MBI programme, for the treatment of depressive, anxious and adaptive symptoms in patients in mental health settings.
Approximately 90 patients suffering from depressive, anxious or adjustment disorders recruited from Spanish mental health settings will be randomised to receive 8 weekly 2 hours group sessions of ABCT, 8 weekly 2.5 hours group sessions of adapted MBSR (with no full-day silent retreat) or treatment as usual (TAU), with a 1:1:1 allocation rate. Patients in the ABCT and adapted MBSR groups will also receive TAU. The main outcome will be general affective distress measured by means of the 'Depression Anxiety Stress Scales-21' at post-test as primary endpoint. Other outcomes will be quality of life, mindfulness, self-compassion and the use of healthcare services. There will be a 6-month follow-up assessment. Intention-to-treat analysis will be conducted using linear mixed models. Per-protocol and secondary outcome analyses will be performed. A data monitoring committee comprising the trial manager, the ABCT and MBSR teachers and an independent clinical psychologist will monitor for possible negative side effects.
Approval was obtained from the Ethics Committee of the General University Hospital of Castellón, Spain. The results will be submitted to peer-reviewed specialised journals, and brief reports will be sent to participants on request.
NCT03425487.
抑郁、焦虑和适应障碍在心理健康门诊患者中极为普遍。心理健康问题资金的缺乏导致治疗效果不佳和疾病负担沉重。旨在治疗这些症状的新型具有成本效益的团体干预措施可能是减轻精神卫生机构医疗负担的合适解决方案。基于正念的干预措施（MBIs）已显示出能显著减轻焦虑、抑郁和适应症状。近期研究强调了同情作为关键改变机制的影响。然而，MBIs只是隐含地涉及同情，而基于同情的方案则将其视为心理治疗的核心方面。在这项随机对照试验中，我们假设提供基于依恋的同情疗法（ABCT，一种基于同情的方案）在治疗心理健康环境中患者的抑郁、焦虑和适应症状方面，将比基于正念的减压疗法（MBSR，一种传统的MBI项目）更有效。
从西班牙心理健康机构招募的约90名患有抑郁、焦虑或适应障碍的患者将被随机分配，分别接受为期8周、每周2小时的ABCT团体治疗、为期8周、每周2.5小时的适应性MBSR团体治疗（无全天静修）或常规治疗（TAU），分配比例为1:1:1。ABCT组和适应性MBSR组的患者也将接受TAU。主要结局将是在测试后通过“抑郁焦虑压力量表-21”测量的一般情感困扰，作为主要终点。其他结局将包括生活质量、正念、自我同情以及医疗服务的使用情况。将进行为期6个月的随访评估。将使用线性混合模型进行意向性分析。将进行符合方案分析和次要结局分析。一个由试验管理者、ABCT和MBSR治疗师以及一名独立临床心理学家组成的数据监测委员会将监测可能的负面副作用。
已获得西班牙卡斯特利翁综合大学医院伦理委员会的批准。研究结果将提交给同行评审的专业期刊，并应要求向参与者发送简要报告。
NCT03425487。
