This was the first randomized controlled trial of LGP plus treatment as usual versus treatment as usual. The study was conducted with 164 adults with bipolar disorder receiving care in a community mental health center and found that all patients improved over the one-year study duration. Although study results did not show a statistically significant difference between treatment groups at the 12-month follow-up, it must be emphasized that fewer than half of patients randomly assigned to LGP actually participated fully in the intervention. Relatively low rates of study participation and similarly low rates of LGP attendance underscore the difficulties in conducting controlled trials with individuals with bipolar disorder in community mental health center settings. Despite these limitations, secondary analyses give some indication that LGP plus treatment as usual had an effect in the expected direction (more positive attitudes toward medication treatment); however, this effect appeared to disappear over time in the absence of structured and ongoing intervention. Although most individuals self-reported taking approximately 80% of prescribed bipolar medication treatments at baseline, DAI scores suggested that individuals had mixed attitudes toward medications. Additionally, individuals with depressive symptoms that were more severe at baseline trended to have lower DAI scores (indicating poorer attitudes toward medication) at the end of the study.
The suboptimal participation in LGP sessions in our study contrasts sharply with the approximately 80% of participants who attended 75% or more of LGP sessions in the two prior effectiveness trials of collaborative care models that included the LGP intervention (14
). It may be that these patients differed systematically in some way from the patients in our study: the study by Bauer and colleagues (14
) involved veterans and the study by Simon and colleagues (16
) involved members of a managed care health organization (HMO). The Department of Veterans Affairs care setting and culture may facilitate higher participation and retention rates in clinical trials, whereas managed care populations are often healthier and less impaired. As might be expected from a public-sector care population, this group of individuals with bipolar disorder was quite ill at baseline, with relatively low functioning. Approximately 75% of our sample had a history of suicide attempts, with an average of one to five previous hospitalizations for mental disorders or substance abuse. It is possible that attitudes toward medication (and perhaps psychosocial therapies) in this sample might have been shaped by the experience of rather severe ongoing symptoms, as well as by a history of extensive family and personal trauma. It has been suggested that individuals with more severe symptoms or a longer duration of illness may respond less well to psychosocial treatments for bipolar disorder, compared with individuals with illness of more recent onset or those who are euthymic (6
). Alternatively, there may be factors related to receiving care for bipolar disorder in a community mental health center that impede treatment, that are not found in the Department of Veterans Affairs (14
) or in staff model HMOs (16
The most notable difference between other trials (14
) and the study presented here is that LGP was a stand-alone treatment in our study, whereas in other trials it was part of an integrated care management package. Nonetheless, there appeared to be a progressive increase in effect size with LGP “dose,” indicating either that sufficient participation in LGP, even without an integrated care model, can achieve the desired effect or that participants who participate adequately in the intervention are the ones who will have the greatest benefit.
Challenges to participation in our study often centered on group time scheduling, transportation problems getting to the clinic, and competing life demands, such as work or child care. A number of individuals did not own a car and relied on public transportation, which was not always readily available during the times the group sessions were scheduled, despite the fact that group leaders tried to optimize the timing of group sessions for participants. An additional impediment to the implementation of psychoeducation in some cases was the group process itself. Although LGP groups can be supportive and motivating for some individuals with bipolar disorder (30
), in other instances, variations within the group, such as the presence of individuals with psychotic symptoms, can be disruptive. The heterogeneity within LGP groups, such as differences in cultural and educational background or health literacy could contribute to isolation of some group members. De Andrés and colleagues (31
) conducted an uncontrolled prospective study of LGP taught in a group format, noting that individuals participating in LGP had improvements in depressive symptoms and self-reported stabilization of mood. As with the study presented here, the study by De Andrés and colleagues (31
) had better participant retention in phase I (80%) and comparatively lower participation in phase II (38%). However, without a comparison group it is difficult to assess whether symptom improvement was simply related to improvement that might have occurred in the course of usual clinical care or was a unique effect of LGP.
Simple feasibility issues such as scheduling can make the LGP group format more difficult, thus attenuating in a real-world application any benefit that may accrue from the mutual learning, support, and destigmatization that are benefits of the group format (13
). Accordingly, LGP has been reformatted and manualized as an individual treatment option to facilitate dissemination to those who cannot or will not participate in groups (32
). Alternative methods to work around scheduling and transportation problems include the use of telephone-based LGP, as has been used by some groups of investigators (33
Findings and recommendations based on study results should be interpreted while acknowledging that the study sample included mainly patients with depressive symptoms and was drawn entirely from a community mental health center. Although depression is the predominant mood state among individuals with bipolar disorder and the community mental health center represents a typical real-world setting in which many bipolar patients receive care, findings may not be generalizable to populations with bipolar disorder symptoms of mania or those receiving treatment in other mental health care settings. Also, the sample was predominantly female. It is possible that the nature of a group psychotherapy intervention is more acceptable to women than men. An uncontrolled study of LGP among individuals with bipolar disorder conducted in Switzerland similarly enrolled a preponderance of female patients (31
). Additional limitations include the fact that reliance on self-report may underestimate treatment adherence, there were no direct quantitative measures of fidelity to the LGP intervention, study raters were not blinded to treatment assignment, and data were not collected on number of visits or types of services in treatment as usual for study participants—there may have been differences between study groups in the treatment as usual. Finally, LGP in this study was a stand-alone intervention. Integration of LGP with other interventions, such as nurse-delivered case management, as part of a package of care might have led to more robust improvements in attitudes toward medication treatment (14