Centre of Psychiatry Glostrup, Copenhagen University
Psychiatric University Hospital, Aarhus
Department of Psychology University of Copenhagen
Amager Hospital, Department of Psychiatry, Copenhagen University
Sct Hans Hospital, Roskilde
Psychiatric Hospital South, County of South Jutland
State University Hospital, Department of Psychiatry, Copenhagen
Copenhagen
Bispebjerg Hospital, Department of Psychiatry, Copenhagen University, Copenhagen
Psychiatric University Hospital, Aarhus
Bispebjerg Hospital, Department of Psychiatry, Copenhagen
Research Centre for Prevention and Health, Copenhagen County, Denmark
Correspondence: Associate Research Professor Bent Rosenbaum, Centre of Psychiatry Glostrup, Unit for Psychotherapy, Education and Research, University of Copenhagen, Ndr.Ringvej, DK-2600 Glostrup, Denmark.Tel: (45) 4323 3401; fax: (45) 4323 3987; e-mail: bros{at}glostruphosp.kbhamt.dk
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ABSTRACT |
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Aims To describe the Danish National Schizophrenia Project and to measure the outcome of two different forms of intervention after 1 year, compared with standard treatment.
Method A prospective, prospective, longitudinal, multicentre investigation included 562 patients, consecutively referred over a 2-year period, with a first episode of psychosis. Patients were allocated to supportive psychodynamic psychotherapy as a supplement to treatment as usual, an integrated, assertive, psychosocial and educational treatment programme or treatment as usual.
Results There was a non-significant tendency towards greater improvement in social functioning in the integrated treatment group and the supportive psychodynamic psychotherapy group compared with the treatment as usual group. Significance was reached for some measures when the confounding effect of drug and alcohol misuse was included.
Conclusions Integrated treatment and supportive psychodynamic psychotherapy in addition to treatment as usual may improve outcome after 1 year of treatment for people with first-episode psychosis, compared with treatment as usual alone.
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INTRODUCTION |
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Background of the study
The Danish National Mental Health Service has a long tradition of equal
access to and free treatment for all inhabitants regardless of their location,
income, ethnicity or religion. Psychiatric treatment is organised according to
sector, and there is no private psychiatric hospital in Denmark. The National
Mental Health Service has 4100 beds, approximately 105 community mental health
centres and 125 private specialists in psychiatry in the adult psychiatry
section. General practitioners and private specialists treat only a small
percentage of patients with schizophrenia and related disorders. All
specialists in psychiatry complete the same theoretical courses as part of
their specialist training. The pathways to treatment for patients with
psychosis and the quality of their psychiatric care can be considered to be
equal in all psychiatric units throughout the country.
Our study was designed to test whether supportive psychodynamic psychotherapy in addition to treatment as usual or an integrated, assertive psychosocial and educational treatment programme could improve the course of illness compared with treatment as usual. We wanted to explore whether the treatment methods in our investigation, including treatment as usual, would help patients to improve their psychic and social functioning, and whether the interventions would lead to greater improvement than usual treatment alone, with respect to symptoms and social functioning.
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METHOD |
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Study participants
The principal inclusion period started on 1 October 1997 and lasted 2
years. Participants were consecutively referred patients, aged 1635
years, with a first psychotic episode of a schizophrenic spectrum disorder
diagnosed by ICD10 criteria (F2029;
World Health Organization,
1992). Written informed consent had to be obtained from all
patients, although not necessarily in the initial phase of the treatment.
Patients were excluded if they had a diagnosis of mental retardation or
organic brain damage, or were not sufficiently proficient Danish speakers.
Patients with a first episode of psychosis, admitted to either an in-patient unit or a community mental health centre, were systematically assessed within 2 weeks and included if they fulfilled the above criteria. The assessment was conducted by members of a trained, independent research team connected to the centre. Inclusion or exclusion was decided by the team.
Treatment allocation
Two centres (52% of the sample) randomised the patients individually to
either treatment 2 or treatment as usual. In three centres (13% of the
sample), patients from the first part of the intake were allocated to
treatment 1 and those from the second part of the intake to treatment as usual
(Fig. 1). This was necessitated
by the requirement to complete the treatments being studied in a relatively
short period with sufficient numbers of patients. In five centres (14% of the
sample), patients were only offered treatment treatment 1 (in addition to
usual treatment), and six centres (21% of the sample) offered only usual
treatment to their patients.
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Assessments
At baseline the following data were collected:
The test battery was repeated in years 1 and 2, and is currently being repeated in year 5. All assessments were conducted by trained, independent interviewers.
The assessment of treatment as usual encompassed a detailed registration of the elements of treatment for each patient during the intervention period and 3 years after, covering seven domains of the psychiatric treatment: continuity in doctorpatient relationship; treatment frames (in-patient or out-patient); medication; psychotherapy; milieu therapy; short-term family groups for the relatives; and training in daily activities.
Intervention treatments
The two intervention treatments were conducted according to manuals.
Regular supervision was provided for both kinds of intervention to enhance
adherence to the manualised procedures. The manualised psychodynamic
psychotherapies for group treatment (Lajer & Valbak, unpublished,
available from the authors on request in Danish) and for individual treatment
(Rosenbaum & Thorgaard, unpublished, available from the authors on
request) aimed at a realistic cognition of psychosocial events (attitudes
towards illness, realistic social goals, and emotional reactions in
interpersonal relationships) and were focused on emotions, intrapsychically as
well as interpersonally. The psycho-educational family treatment was
manualised according to McFarlane et
al, 1995. The focus of each session was problem-solving and
the development of skills to cope with aspects of the illness. The social
skills training was based on selected modules from Liberman et al
(1986) and Bellack et
al (1997).
Statistical analysis
The multicentre structure of this study had to be taken into account in the
analyses since two patients treated at the same centre might not give
independent observations. Logistic regression with generalised estimating
equations (Hardin & Hilbe,
2003; Donner & Klar,
2004) was used for dichotomous variables and linear mixed models
were used for continuous variables. These methods were used to compare the
three study groups at baseline, at 1 year and for differences between
base-line and 1 year. In the calculation of changes from baseline to year 1,
the analysis was adjusted for baseline values. Members of the independent
research teams met twice a year and rated videotape of patient assessments.
The results of 12 rating sessions were used for the calculation of
reliability. It was measured for PANSS and GAF by calculating the intraclass
correlation coefficient (ICC; Bartko &
Carpenter, 1976). All tests were two-sided, and all analyses were
executed by using SAS software version 8.2. Owing to multiple comparisons, the
Bonferroni correction was used in the interpretation of the results at
baseline and for the pairwise comparisons at 1 year of treatment.
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RESULTS |
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Reliability of study measures
The ICC for PANSS positive symptoms was 0.70, for PANSS negative symptoms
it was 0.74, for GAF symptoms it was 0.56 and for GAF function it was 0.74.
The ICC agreement is thus good for PANSS and GAF function, and moderate but
acceptable for GAF symptoms.
Comparison between the three groups at baseline
The groups were similar at baseline in terms of age, diagnosis, PANSS
positive score, GAF symptom score, GAF function score, GAF total score, and
admission/non-admission to hospital during the year before inclusion in the
study (i.e. admitted with a diagnosis of a psychiatric illness other than F20
psychosis). A significant lower PANSS negative symptom score for the treatment
2 group disappeared when the Bonferroni correction was used.
At year 1, data were obtained from 450 patients (80%). These participants did not differ from the group for whom data were not obtained, in terms of age, gender, diagnosis, GAF and PANSS scores. Furthermore, there was no statistical difference between the three investigated groups. In the F20 group of patients with schizophrenia, 80% participated in the rating at year 1.
Improvement in symptoms and social function after 1 year of treatment
At year 1, a significant improvement was found for GAF symptom score, GAF
function score, GAF total score, PANSS positive score (P<0.0001)
and PANSS negative score (P<0.04) when the three treatment groups
were sampled together. More than half of the sample (54%) had more contact
with friends in year 1 compared with the year prior to baseline, 18% had more
work and 58% had fewer symptoms.
Comparing the improvements in the three groups at year 1 did not reveal any
significant difference between each of the two intervention groups and the
usual treatment group (Table
3). Non-significant tendencies were found for hospital admission
and GAF function. The reduction in time spent in hospital (. the year
before inclusion) was greater in patients receiving treatment 2 or treatment
as usual than in patients receiving treatment 1 (P=0.08), whereas
treatments 1 and 2 both improved the patients GAF function scores more
than treatment as usual (P = 0.06). Comparisons between treatment 1
and treatment as usual were in favour of the intervention: GAF total
(P=0.03). With the Bonferroni correction, however, this difference
disappeared. When we controlled for drug and alcohol misuse as a confounding
factor, we found that both intervention treatments produced significant
improvements in GAF function score (P=0.02) and PANSS negative score
(P=0.02).
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Five people died by suicide during year 1 (0.9% of the whole sample), including two unexplained deaths; no difference was found between suicide rates in the intervention groups and in the usual treatment group.
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DISCUSSION |
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Even though our study participants had only been exposed for a limited time to the specific intervention, it is an interesting (although from clinical experience not unexpected) finding that patients who do not misuse alcohol or drugs are receptive to the specific interventions to such an extent that for some variables it results in a statistically significant difference between the improvements in the intervention groups compared with treatment as usual. This may serve as a guideline to the selection of the patients who might benefit from psychotherapy in the initial phase of treatment.
The multisite study
Conducting a prospective, long-term study involving 16 centres is a
laborious process with many pitfalls
(Kraemer, 2000). The strengths
of the multisite model in our study are the quantity of consecutively referred
patients; the inclusion of different types of treatment centres (small/big,
urban/rural, university/non-university) in all three groups being compared;
the percentage of the Danish population covered by the study (approximately
45%); the comparison of two different therapies with standard treatment of
supposedly good quality; and that the treatment was conducted mainly by
therapists with standard training rather than master clinicians. The study was
thus both naturalistic and realistic, and mimicked the actual conditions of
the Danish national health system at the time of the health systems
development (19982000). This supports the generalisations of the
results as well as the possibility of recommending in the future the use of
both clinical measures and treatment methods in the day-to-day practice of
psychiatry. Furthermore, it is in accordance with recent reports emphasising
that pragmatically defined public health, integrated treatment programmes and
effectiveness studies in many ways are more useful in the planning of
schizophrenia prevention than narrowly defined regulatory models and efficacy
studies (Lebowitz & Pearson,
2001; Gilbody et al,
2002).
An additional positive element of the long-term multisite project is the establishment of a network of centres that can collaborate through adopting the same treatment methods, the same measurement scales and upholding the same treatment values. The collaboration requires an idealistic approach and has to overcome the potential lack of funding. The reward for each centre is the provision of training of interviewers in the use of psychometric scales and of therapists in the chosen methods of treatment. As a result of these collaborative efforts, the reliability of the ratings of PANSS and GAF was satisfactory.
Comparison with other studies
Previous studies of first-episode psychosis have found a positive outcome
for various integrated treatments compared with standard treatment
(Martindale et al,
2000: pp. 200292). These integrated treatment programmes
all differ in content, combination of treatment forms or length of treatment,
and it is hard to compare them directly with our study. Furthermore, the
active curative factors in these studies have been hard to distil. Possible
curative factors in our integrated treatment programme (treatment 2) might be
the rapid, consistent and long-term involvement of the treatment team; the
specific targeting of the patients return to work, school or other
educational programme; and the specific targeting of the attempt to enable
in-patients to progress to out-patient treatment.
Previous studies comparing psychodynamic psychotherapy and standard treatment are few and have diverse results, some in favour of the psychodynamic treatment (Karon & VandenBos, 1981), others against (May, 1968). Positive outcome has mainly been associated with treatment by experienced therapists or master clinicians (Karon & VandenBos, 1981) and/or with the formation of a therapeutic alliance (Frank & Gunderson, 1990). However, none of the previous studies concerned patients with first-episode psychosis, and it is by no means given that we can extend the findings from these previous studies of psychotherapy of schizophrenia to our sample.
One limitation of our study is the lack of individual randomisation of all patients. It was, however, the price we had to pay in order to include many different types of centre. Another limitation to the interpretation of our results is the lack of 1-year data for 20% of the patients. This was not expected, but cannot be considered exceptionally high (Gilbody et al, 2002). No difference in adherence to the project was found between the treatment 1 group (0.86) and the treatment 2 group (0.81). However, a greater number of patients remaining in the study after 1 year might have increased the possibility of a significant effect of the interventions.
Finally, the study was constricted by the use of a limited battery of tests and by not including detailed analysis of possible factors confounding the effect of therapy, such as duration of untreated psychosis, premorbid social function, interpersonal attitude and behaviour in school. We did, however, include drug and alcohol misuse, and controlling the data for these confounding factors changed some measures in favour of the two treatment interventions.
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Clinical Implications and Limitations |
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LIMITATIONS
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ACKNOWLEDGMENTS |
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A 6-year grant from the Danish Ministry of Health made it possible to carry the project through to the treatment phase. Participating counties have also contributed financially.
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Received for publication March 4, 2004. Revision received September 29, 2004. Accepted for publication October 5, 2004.
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