Janssen Noortje, Huibers Marcus J H, Lucassen Peter, Voshaar Richard Oude, van Marwijk Harm, Bosmans Judith, Pijnappels Mirjam, Spijker Jan, Hendriks Gert-Jan
Behavioural Science Institute, Radboud University, Nijmegen, The Netherlands.
Department of Primary and Community Care, Radboud University Medical Centre Nijmegen, Nijmegen, The Netherlands.
BMC Psychiatry. 2017 Jun 26;17(1):230. doi: 10.1186/s12888-017-1388-x.
Depressive symptoms are common in older adults. The effectiveness of pharmacological treatments and the availability of psychological treatments in primary care are limited. A behavioural approach to depression treatment might be beneficial to many older adults but such care is still largely unavailable. Behavioural Activation (BA) protocols are less complicated and more easy to train than other psychological therapies, making them very suitable for delivery by less specialised therapists. The recent introduction of the mental health nurse in primary care centres in the Netherlands has created major opportunities for improving the accessibility of psychological treatments for late-life depression in primary care. BA may thus address the needs of older patients while improving treatment outcome and lowering costs.The primary objective of this study is to compare the effectiveness and cost-effectiveness of BA in comparison with treatment as usual (TAU) for late-life depression in Dutch primary care. A secondary goal is to explore several potential mechanisms of change, as well as predictors and moderators of treatment outcome of BA for late-life depression.
METHODS/DESIGN: Cluster-randomised controlled multicentre trial with two parallel groups: a) behavioural activation, and b) treatment as usual, conducted in primary care centres with a follow-up of 52 weeks. The main inclusion criterion is a PHQ-9 score > 9. Patients are excluded from the trial in case of severe mental illness that requires specialized treatment, high suicide risk, drug and/or alcohol abuse, prior psychotherapy, change in dosage or type of prescribed antidepressants in the previous 12 weeks, or moderate to severe cognitive impairment. The intervention consists of 8 weekly 30-min BA sessions delivered by a trained mental health nurse.
We expect BA to be an effective and cost-effective treatment for late-life depression compared to TAU. BA delivered by mental health nurses could increase the availability and accessibility of non-pharmacological treatments for late-life depression in primary care.
This study is retrospectively registered in the Dutch Clinical Trial Register NTR6013 on August 25th 2016.
抑郁症状在老年人中很常见。在初级保健中，药物治疗的有效性以及心理治疗的可及性都很有限。行为疗法治疗抑郁症可能对许多老年人有益，但这种治疗方式仍然大多无法获得。与其他心理治疗相比，行为激活（BA）方案不太复杂，更容易培训，这使得它们非常适合由不太专业的治疗师提供。荷兰初级保健中心最近引入心理健康护士，为改善初级保健中晚期抑郁症心理治疗的可及性创造了重大机遇。因此，BA可能满足老年患者的需求，同时改善治疗效果并降低成本。本研究的主要目的是比较BA与常规治疗（TAU）对荷兰初级保健中晚期抑郁症的有效性和成本效益。次要目标是探索几种潜在的变化机制，以及BA治疗晚期抑郁症的治疗效果的预测因素和调节因素。
方法/设计：采用两组平行的整群随机对照多中心试验：a）行为激活，和b）常规治疗，在初级保健中心进行，随访52周。主要纳入标准是PHQ-9评分>9。如果患者患有需要专科治疗的严重精神疾病、自杀风险高、药物和/或酒精滥用、先前接受过心理治疗、在过去12周内改变了规定抗抑郁药的剂量或类型，或有中度至重度认知障碍，则排除在试验之外。干预措施包括由经过培训的心理健康护士进行8次每周30分钟的BA治疗。
我们预计与TAU相比，BA对晚期抑郁症是一种有效且具有成本效益的治疗方法。由心理健康护士提供的BA可以增加初级保健中晚期抑郁症非药物治疗的可及性和可获得性。
本研究于2016年8月25日在荷兰临床试验注册中心NTR6013进行回顾性注册。
