GGZ ingeest/VU University Medical Center, dept, of Psychiatry, Amsterdam, the Netherlands.
BMC Psychiatry. 2011 Aug 17;11:133. doi: 10.1186/1471-244X-11-133.
Bipolar disorder is a severe mental illness with serious consequences for daily living of patients and their caregivers. Care as usual primarily consists of pharmacotherapy and supportive treatment. However, a substantial number of patients show a suboptimal response to treatment and still suffer from frequent episodes, persistent interepisodic symptoms and poor social functioning. Both psychiatric and somatic comorbid disorders are frequent, especially personality disorders, substance abuse, cardiovascular diseases and diabetes. Multidisciplinary collaboration of professionals is needed to combine all expertise in order to achieve high-quality integrated treatment. 'Collaborative Care' is a treatment method that could meet these needs. Several studies have shown promising effects of these integrated treatment programs for patients with bipolar disorder. In this article we describe a research protocol concerning a study on the effects of Collaborative Care for patients with bipolar disorder in the Netherlands.
METHODS/DESIGN: The study concerns a two-armed cluster randomised clinical trial to evaluate the effectiveness of Collaborative Care (CC) in comparison with Care as usual (CAU) in outpatient clinics for bipolar disorder or mood disorders in general. Collaborative Care includes individually tailored interventions, aimed at personal goals set by the patient. The patient, his caregiver, the nurse and the psychiatrist all are part of the Collaborative Care team. Elements of the program are: contracting and shared decision making; psycho education; problem solving treatment; systematic relapse prevention; monitoring of outcomes and pharmacotherapy. Nurses coordinate the program. Nurses and psychiatrists in the intervention group will be trained in the intervention. The effects will be measured at baseline, 6 months and 12 months. Primary outcomes are psychosocial functioning, psychiatric symptoms, and quality of life. Caregiver outcomes are burden and satisfaction with care.
Several ways to enhance the quality of this study are described, as well as some limitations caused by the complexities of naturalistic treatment settings where not all influencing factors on an intervention and the outcomes can be controlled.
The Netherlands Trial Registry, NTR2600.
双相情感障碍是一种严重的精神疾病，会对患者及其照顾者的日常生活造成严重影响。常规护理主要包括药物治疗和支持性治疗。然而，相当一部分患者对治疗反应不佳，仍频繁发作，间歇性症状持续存在，社会功能较差。精神和躯体共病障碍很常见，特别是人格障碍、药物滥用、心血管疾病和糖尿病。需要专业人员的多学科合作，结合所有专业知识，以实现高质量的综合治疗。“协作护理”是一种可以满足这些需求的治疗方法。多项研究表明，这些综合治疗方案对双相情感障碍患者有良好的效果。本文描述了一项关于荷兰双相情感障碍患者协作护理效果的研究方案。
方法/设计：该研究是一项两臂集群随机临床试验，旨在评估协作护理（CC）与常规护理（CAU）相比对双相情感障碍或一般心境障碍门诊患者的有效性。协作护理包括针对患者设定的个人目标的个性化干预措施。患者、照顾者、护士和精神科医生都是协作护理团队的一部分。该方案的要素包括：合同和共同决策、心理教育、问题解决治疗、系统复发预防、结果监测和药物治疗。护士协调方案。干预组的护士和精神科医生将接受干预培训。将在基线、6 个月和 12 个月时测量效果。主要结果是社会心理功能、精神症状和生活质量。照顾者的结果是负担和对护理的满意度。
描述了几种方法来提高这项研究的质量，以及由于自然治疗环境的复杂性而导致的一些限制，在这种环境中，不能控制所有干预因素和结果的影响。
荷兰试验注册处，NTR2600。
