Bipolar disorder is a severe mental illness with an estimated lifetime prevalence of 1.5 to 2%[1
]. It is characterized by recurrent episodes of extreme mood changes. Several studies [2
] show that on average patients suffer from manic, depressive, hypomanic or mixed symptoms for about half of the time despite treatment. Even during so-called euthymic periods, i.e. when they are formally not in a mood episode, many patients suffer from subsyndromal symptoms that negatively influence their quality of life [5
]. Informal caregivers also suffer a substantial burden by the illness, not only during episodes [6
Treatment of bipolar disorders in the Netherlands primarily consists of pharmacotherapy, supportive treatment, and psycho education, sometimes combined with improvement of self-management skills or psychotherapy. Many patients respond well to this treatment and may stabilize for longer periods. However, a substantial number of patients do not respond adequately to these treatment efforts. They suffer from frequent episodes, persisting symptoms, cognitive problems, limited social support and poor social functioning. Comorbid psychiatric disorders, such as personality disorders and substance abuse, are common, as are somatic disorders i.e. cardiovascular disease, partly associated with prolonged use of maintenance medication [8
Multidisciplinary collaboration of professionals is needed to involve optimal specialist skills on all aspects of the disorder, and to properly combine all expertise in order to achieve an optimally integrated care [10
]. The Dutch guideline for the treatment of bipolar disorders [11
] recommends such an integrated treatment. The guideline advises that treatment be targeted at reducing symptoms, acceptance of the illness, promoting treatment adherence, stabilising social rhythm, recognising early signs and symptoms and take proper actions when these occur, diminishing social problems and maximising social participation. It is advised to actively engage caregivers or family members in this treatment. Although it is widely acknowledged that integrated treatment programs can be of great value for patients with bipolar disorder, research on the effectiveness of such programs for patients with a bipolar disorder is scarce.
Collaborative Care (CC) programs have been developed to integrate multidisciplinary care for complex disorders and to date, three research projects show promising results with bipolar patients. Bauer et al. [12
] have implemented a CC model for patients with bipolar disorder and measured the effects in two randomised controlled trials. Patients participated in the Life Goals Program. The intervention consisted of improving patients' self-management skills through psycho education; supporting providers' decision making through simplified practice guidelines; and enhancing access to care and continuity of care. The care manager, a nurse or a social worker, provided actively outreaching care when a patient was at risk of losing contact with mental health workers. Each patient made a 'relapse prevention plan', aimed at the early recognition of relapses. The care manger contacted the patient at least every three months. The program also provides guidelines for specific pharmacotherapy. Bauer et al. [12
] found significantly reduced number of weeks in manic episodes in the experimental group, although no significant effect was found on weeks depressed. Patients showed improved social functioning, quality of life and treatment satisfaction. Total costs were similar in both groups. The Life Goals Program was extended by Kilbourne et al. [14
], to address the many medical comorbidities present in patients with bipolar disorders.
Simon et al. [16
] have explored the effects of adding intensive nursing care to treatment of patients with bipolar disorder. This consisted of an emergency plan, monthly telephone calls in which symptoms were monitored, sharing of information between nurse and psychiatrist, and outreach interventions such as crisis intervention. Patients were given the choice of participation in the Life Goals Program, mentioned above. After receiving the intervention over a period of one or two years, patients in the experimental group showed significant less severe manic symptoms of shorter duration. Also in this study, there was no effect on depressive symptoms. Extra costs of this treatment were relatively low compared to the control group.
Suppes et al. [18
] studied the effects of the Texas Medication Algorithm project in patients with bipolar disorder. This project aimed to develop and implement algorithms for pharmacotherapy for bipolar patients. Clinics implementing this guideline were compared in a RCT to clinics which did not use the guideline. In the experimental group, a coordinator was added to the care team. This coordinator provided psycho education to the patient and the family. He kept in contact with the patient, and assessed symptoms and side effects of medication prior to each consultation with the psychiatrist. The coordinator informed the psychiatrist about the results of these assessments. The aim was to achieve a higher efficiency of the psychiatric consultations. The results of the study show a significant improvement of psychiatric symptoms of patients in the intervention group in the first three months. During the next nine months, patients in the control group improved as well, but less than patients in the intervention group. Patients in the intervention group reported significant improvement of manic, but not depressive and psychotic symptoms.
It is striking that all three studies show improvement of manic but not depressive symptoms.
In the Netherlands, until now no studies have been performed on the effects of CC for patients with bipolar disorder. The current study will be the first to implement CC for patients with bipolar disorder, and moreover, to add a specific intervention to improve depression. Furthermore, CC appears to offer good possibilities to strengthen the position of the nurse in the care process for patients with a bipolar disorder, both at the organizational and content levels.
In this article we describe the study protocol for investigating the effectiveness of a CC program for patients with bipolar disorder. We set out the following three research questions to answer:
A What are the effects of a CC program, compared to Care as Usual (CAU), for patients with bipolar disorder, with regard to their psychosocial functioning, psychiatric symptoms, quality of life, attitudes towards medication, mastery, and satisfaction with care?
B What are the effects of a CC program, compared to CAU, for informal caregivers of patients with a bipolar disorder, with regard to the experienced burden and satisfaction with care?
C What is the cost effectiveness of a CC Program compared to CAU?