To our knowledge this is the first long term RCT follow-up (12 years) study on intensive Integrated Treatment for patients with recent-onset schizophrenia.
Significantly fewer patients receiving IT (11 of 28 patients in the IT group and 12 of 17 in the TAU group) were involuntary hospitalized. This is an important finding and should have implications in planning of services for patients with schizophrenia. There were, however, no difference in the number of days they were involuntary admitted. No significant differences were found between groups receiving integrated treatment or treatment-as-usual with respect to number of inpatient days, number of patients admitted to psychiatric wards, number of admissions to psychiatric wards, use of outpatient coercion or number of outpatient contacts over a period of 12 years. Although median time to readmission was considerably longer for the IT group, this difference did not reach statistical significance (possibly because of the sample size). Given that no effects on hospitalization were found in the first two years, these findings might not be surprising and limited conclusions can be drawn given that only 45 patients were included in the analyzes.
The findings are in line with other recent studies on 3–5 year outcomes reporting that time-limited early specialized interventions for schizophrenia do not improve outcome over time
This lack of significant long-term effects on the use of services may be understood in several ways. Time-limited evidence- based psychosocial and pharmacological interventions do alleviate the present suffering from the illness, but may not change or hamper the long-term course of the illness
. It is, however, possible that there are long-term effects of such interventions, but that such effects only applies to subgroups of patients responding to elements of the interventions
. It is interesting that 10 of the 45 patients in this study counted for 76% of all inpatient days during the 12-year follow-up period. This group of patients with schizophrenia with extensive use of psychiatric services may represent a group which needs special attention and could potentially gain much from long term standardized care.
In the original study, IT had a beneficial impact on negative symptoms, minor psychotic episodes, and stabilizing positive symptoms
. In modern psychiatric care, improvements in negative symptoms might reduce the need for community services more than reduce the need for hospital admissions.
In this study the participants had recent-onset but established psychosis. The majority (87%) entered the study after their first hospitalization and had been hospitalized on average over 100 days before inclusion.
It is possible that integrated interventions at an earlier stage could have improved their long-term use of services. Such an assumption is supported by the results from the early Treatment and Intervention in Psychosis study where early detection and intervention of recent onset schizophrenia improved 10 year outcomes
[20, 21]. In this study the patients in both the experimental and the control group received early intervention treatment. The difference was that those in the experimental group received this treatment significantly earlier then the controls (shorter duration of untreated psychosis). Support for the effects of even earlier interventions comes from a recent meta-analysis on “risk of transition to psychosis” among persons with high risk for psychosis. This study suggests that transition into psychosis among high risk persons may be reduced by cognitive therapy and antipsychotic medications
Yet another explanation for the lack of long-term effects on the use of services of the early integrated treatment demonstrated in our study is that the treatment was too time-limited. The effects of early interventions during the treatment period have been proven through multiple trials. Long-term continuous interventions may be needed if clinically significant effects are to be sustained. In the Prevention and Early Intervention Program for Psychoses in London, Ontario, long-term symptom improvements were obtained after providing the patients with five years continued, albeit less intensive, specialized treatment
Involuntary admissions remain a controversial medical procedure associated with ethical dilemmas and patients with schizophrenia are among those most often involuntary admitted
. Research show that involuntary treatment is associated with more severe illness, reduced treatment motivation and less insight
Reduction in the use of involuntary admissions is an important treatment goal. Our results suggest that long-term reduction in involuntary admissions of patients with schizophrenia is attainable by providing early integrated treatment. Forced admissions are not only a result of symptom exacerbations, but may be associated with other psychosocial variables as insight
, violence and adherence to psychosocial treatment
. It is therefore possible that the group difference in forced admissions could be explained by variety of such other aspects of the illness. Components of the IT such as cognitive–behavioural family communication and problem solving skills training, individual cognitive-behavioural strategies for residual symptoms and disability have many similarities to a “crisis plan” which is a psychiatric intervention aimed specifically at reducing use of coercive measures
. A RCT on the use of crisis plans found a significant reduction in use of involuntary admissions
. This was not associated with differences in overall admissions, as is the case in our finding.
Use of in- and outpatient services is only one of many factors used as outcome measure in schizophrenia. Recovery in schizophrenia is a complex and multi-dimensional concept encompassing both objective and subjective outcome dimensions
 and an ongoing change progress
. Objective outcome dimensions include symptom remission, employment, housing and relations to others while subjective outcome dimensions include appraisal of life circumstances and self-appraisal. Because of the limited scope of outcome measures in this study the possible long-term effects of IT on these multiple aspects of recovery may be hidden and not revealed.
Data from one patient in the TAU group who died 4 years and 9 months into the follow-up period were included in the statistical analyses and no statistical corrections were made to make up for the lack of data for the remaining period. As this patient died of suicide, which is the worst possible clinical outcome, it would be likely that this patient’s long-term clinical outcome would have been poor if the patient had lived. Therefore the inclusion of this patient’s data in the analyses may somewhat have influenced the results for the TAU group.
A sample size of 45 is too low to reveal reliable differences between the two treatment groups. Only a large sample size or a large effect size would be sufficient to test the hypothesis that the groups do not differ on number of days as in-patients or number of admittances as in-patients. P-values between 0.01 and 0.05 should be interpreted with caution, because of multiple analyses.
This follow-up RCT study is based solely on register data from psychiatric in- and outpatient services. Whether all psychiatric admissions and outpatient treatment periods were attributable to psychotic illness cannot be ascertained.
Another possible source of bias was that the researchers were not blinded or prevented from knowing which group the patients belonged to. However, because the outcome data were based upon objective information on dates and number of incidences, and because the admission data were collected for clinical and legal purposes (and not as a part of the study), the risk of information bias is considered to be minimal.
Use of in- and outpatient services may not be an optimal measure of outcome in schizophrenia and other aspects of recovery should also be considered. Clinically unstable patients and patients with substance abuse were excluded from the study and this possibly reduces the generalizability of the study.
Despite these shortcomings this is the first RCT covering a follow-up period of 12 years. This is considered to be important information for clinical practice. The long observation period and the possibility to get complete data from 90% of the participants are major strengths in the study.
The findings of this long term follow-up study, on the effects of integrated treatment for recent onset psychosis, further strengthen the implications from other recent studies that the short-term effects of early time-limited integrated treatment may not be sustainable. We found that involuntary treatment of patients with schizophrenia can possibly be prevented with early integrated treatment efforts.
Our findings must be replicated before any conclusions can be drawn about the effect of IT on long-term use of in- and outpatient services.
RCTs on long-term effects of interventions including early identification and continuous integrated treatment for schizophrenia, focusing on different aspects of recovery, are needed.
Psychological treatments for schizophrenia as a whole are emerging and of potential importance for future studies are the effects of emerging integrative forms of psychotherapy.
It is also important to gain more knowledge about how poor and good outcome schizophrenia can be identified at an early stage of the illness in order to optimize the allocation of health resources.