A randomised multicentre trial of integrated versus standard treatment for patients with a first episode of psychotic illness

Petersen, L.; Jeppesen, Pia; Thorup, Anne; Abel, M.; Øhlenschlæger, Johan; Christensen, Thomas; Krarup, Gertrud; Jørgensen, Per; Nordentoft, Merete

doi:10.1136/bmj.38565.415000.e01

Cited by 493 publications

(454 citation statements)

References 23 publications

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“…At the two year follow-up in the OPUS I trial, we found a mean difference of 0.40 points (standard deviation 1.20) on the negative dimension between the experimental intervention group and control group 17. In the present trial, we aimed to detect the same difference, five year after initiation of treatment, and three years after end of the standard two year SEI treatment.…”

Section: Methodsmentioning

confidence: 61%

“…The ability to affect the negative symptoms in schizophrenia spectrum disorders has been one of the main accomplishments of the OPUS treatment, as shown in the OPUS I trial 17. In the present OPUS II trial, both treatment models compared were able to maintain the level of negative symptoms, observed at baseline, and we were not able to find any effects of the prolonged OPUS intervention on the negative symptoms, nor on any other psychopathological dimensions, functional level, labour market affiliation, cognitive function, or hospital admissions.…”

Section: Discussionmentioning

confidence: 99%

“…For the trials with long term follow-up after the end of the intervention period, the results were more contradictory 1415 16 The largest randomised clinical trial of SEI treatment, the OPUS I trial,3 15 17 found that participants in the intervention group relapsed to the psychopathological and functional levels of the control participants three years after the end of the intervention 15. In a naturalistic study from Canada, researchers testing the effect of five years of SEI treatment found that they could sustain and further reduce the psychopathology and increase the functional level of the participants 18…”

Section: Introductionmentioning

confidence: 99%

“…We therefore aimed to test whether the positive results seen in patients receiving SEI treatment can be sustained if the treatment is prolonged. Given the previous findings of positive effect of the SEI treatment17 19 and the limited pharmacological treatment options for negative symptoms, we tested whether negative symptoms are reduced in a patients receiving prolonged SEI treatment compared with those treated in community health centres after termination of two years of SEI treatment.…”

Section: Introductionmentioning

confidence: 99%

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Five years of specialised early intervention versus two years of specialised early intervention followed by three years of standard treatment for patients with a first episode psychosis: randomised, superiority, parallel group trial in Denmark (OPUS II)

Albert

Melau

Jensen

et al. 2017

BMJ

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Objective To compare the effects of five years of specialised early intervention (SEI) treatment for first episode schizophrenia spectrum disorder with the standard two years of SEI plus three years of treatment as usual.Design Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site.Setting Participants were recruited from six OPUS teams in Denmark between 2009 and 2012. OPUS teams provide SEI treatment to all patients diagnosed with a schizophrenia spectrum disorder in Denmark.Participants 400 participants (51% women) with a mean age of 25.6 (standard deviation 4.3) were randomised to five years of SEI (experimental intervention; n=197) or to two years of SEI plus three years of treatment as usual (control; n=203).Interventions OPUS treatment consists of three core elements—modified assertive community treatment, family involvement, and social skill training—with a patient-case manager ratio of no more than 12:1. For participants randomised to five years of OPUS treatment, the treatment was largely unchanged. Participants randomised to the control group were mostly referred to community health centres after two years of SEI treatment.Main outcomes Follow-up assessments were conducted five years after start of OPUS treatment. Primary outcome was negative symptoms measured on the scale for assessment of negative symptoms (avolition-apathy, anhedonia, alogia, and affective blunting). Secondary outcomes were remission of both negative and psychotic symptoms, psychotic symptoms, suicidal ideation, substance abuse, compliance with medical treatment, adherence with treatment, client satisfaction, days in hospital care, and labour market affiliation.Results Levels of negative symptoms did not differ between the intervention group and control group (1.72 v 1.81 points; estimated mean difference −0.10 (95% confidence interval 0.33 to 0.13), P=0.39). Participants receiving five years of OPUS treatment were more likely to remain in contact with specialised mental health services (90.4% v 55.6%, P<0.001), had higher client satisfaction (estimated mean difference 2.57 points (95% confidence interval 1.36 to 3.79), P<0.001), and had a stronger working alliance (estimated mean difference 5.56 points (95% confidence interval 2.30 to 8.82), P=0.001) than the control group.Conclusions This trial tests SEI treatment for up to five years for patients with first episode schizophrenia spectrum disorder; previous trials have found treatment effects for programmes lasting from one to three years. The prolonged SEI treatment had few effects, which could be due to the high level of treatment provided to control participants and the late start of specialised treatment.Trial registration Clinicaltrial.gov NCT00914238.

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Section: Methodsmentioning

confidence: 61%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Five years of specialised early intervention versus two years of specialised early intervention followed by three years of standard treatment for patients with a first episode psychosis: randomised, superiority, parallel group trial in Denmark (OPUS II)

Albert

Melau

Jensen

et al. 2017

BMJ

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“…A total of 402 papers were identified by the search strategy, from which we identified 28 non-overlapping first episode studies that met inclusion criteria (see Appendix 1) (Montague et al, 1989;Barnes et al, 2000;Craig et al, 2000;de Haan et al, 2000;Drake et al, 2000;Ho et al, 2000;Larsen et al, 2000;Black et al, 2001;Verdoux et al, 2001;Cullberg et al, 2002;Malla et al, 2003;Addington et al, 2004;Sim et al, 2004;Chen et al, 2005;Harris et al, 2005;Manchanda et al, 2005;Melle et al, 2005;Oosthuizen et al, 2005;Petersen et al, 2005;Wade et al, 2005;Clarke et al, 2006;Ucok et al, 2006;Wunderink et al, 2006;Crespo-Facorro et al, 2007;Malla et al, 2007;Vyas et al, 2007;Gorna et al, 2008;Yamazawa et al, 2008). The selected studies included a total of 3998 participants.…”

Section: Studies and Patientsmentioning

confidence: 99%

Duration of untreated psychosis and negative symptoms — A systematic review and meta-analysis of individual patient data

Boonstra

Klaassen

Sytema

et al. 2012

Schizophrenia Research

209

134

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Take-down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. Background: Longer duration of untreated psychosis (DUP) is associated with poorer outcome in terms of positive symptoms, relapse rate, and time to remission. In contrast, the association with negative symptoms is less consistent. Aims: The study had three aims. First, to arrive at a more precise estimate of the correlation between DUP and negative symptoms than previous reviews, by substantially increasing the amount of available data. Second, to see whether the strength of this correlation attenuated over longer follow-up intervals. Third, to determine whether there is a relationship between DUP and changes in negative symptoms. Method: Relevant databases were searched for studies published between December 1992 and March 2009 that reported data on DUP and negative symptoms. We obtained individual patient data where possible and calculated summary correlations between DUP and negative symptoms for each study at baseline, short and long-term follow-up. We used multilevel regression analysis to examine whether the effect of DUP on negative symptoms was the greatest in the early stages of illness. Results: We included 28 non-overlapping studies from the 402 papers detected by the search strategy. After contacting the authors we obtained individual patient data from 16 of these studies involving 3339 participants. The mean DUP was 61.4 weeks (SD = 132.7, median DUP = 12.0). Shorter DUP was significantly associated with less severe negative symptoms at baseline and also at short (1-2 years) and longer term follow-up (5-8 years) (r = 0.117, 0.180 and 0.202 respectively, p b 0.001). The relationship between improvement in negative symptoms and DUP was found to be non-linear: people with a DUP shorter than 9 months showed substantially greater negative symptom reduction than those with a DUP of greater than 9 months. Conclusions: Shorter DUP is associated with less severe negative symptoms at short and long-term follow up, especially when the DUP is less than 9 months. Since there is no effective treatment for negative symptoms, reducing DUP to less than 9 months may be the best way to ameliorate them.

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Effect of Antipsychotic Medication Alone vs Combined With Psychosocial Intervention on Outcomes of Early-Stage Schizophrenia

Guo¹,

Zhai²,

Liu³

et al. 2010

Arch Gen Psychiatry

125

107

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Context Antipsychotic drugs are limited in their ability to improve the overall outcome of schizophrenia. Adding psychosocial treatment may produce greater improvement in functional outcome than does medication treatment alone. Objective To evaluate the effectiveness of antipsychotic medication alone versus combined with psychosocial intervention on outcomes of early stage schizophrenia. Design, Setting, and Participants Randomized controlled trial of a clinical sample of 1268 patients with early stage schizophrenia, conducted at 10 clinical sites in China from 2005–2007. Intervention Patients were randomly assigned to antipsychotic medication treatment only or antipsychotic medication plus 12 months of psychosocial intervention, consisting of psycho-education, family intervention, skills training and cognitive-behavioral therapy, administered over 48 group sessions. Main Outcome Measures The rate of treatment discontinuation or change due to any cause, relapse or remission, and assessments of insight, treatment adherence, quality of life and social functioning. Results The rates of treatment discontinuation or change due to any cause were 32.8% in the combined treatment group and 46.8% in the medication alone group. Comparisons with medication treatment alone showed lower risk for any cause discontinuation with combined treatment (hazard ratios [HR], 0.62; 95% confidence interval [CI], 0.52–0.74; p<0.001); and lower risk for relapse with combined treatment (HR, 0.57; 95%CI, 0.44–0.74; p<0.001). The combined treatment group exhibited greater improvement in insight (p<0.001), social functioning (p=0.002), activities of daily living (p<0.001), and in 4 domains of quality of life as measured by Medical Outcome Study Short-Form 36-item questionnaire (all p-values<0.02). Furthermore, a significantly higher proportion of patients receiving combined treatment obtained employment or accessed education (p=0.001). Conclusions Compared to those receiving medications only, early stage schizophrenia patients receiving medications and psychosocial intervention had a lower rate of treatment discontinuation or change, lower risk of relapse, and improved insight, quality of life and social functioning.

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A randomised multicentre trial of integrated versus standard treatment for patients with a first episode of psychotic illness

Abstract: Objectives To evaluate the effects of integrated treatment for patients with a first episode of psychotic illness. Design Randomised clinical trial. Setting

Cited by 493 publications

References 23 publications

Five years of specialised early intervention versus two years of specialised early intervention followed by three years of standard treatment for patients with a first episode psychosis: randomised, superiority, parallel group trial in Denmark (OPUS II)

Five years of specialised early intervention versus two years of specialised early intervention followed by three years of standard treatment for patients with a first episode psychosis: randomised, superiority, parallel group trial in Denmark (OPUS II)

Duration of untreated psychosis and negative symptoms — A systematic review and meta-analysis of individual patient data

Effect of Antipsychotic Medication Alone vs Combined With Psychosocial Intervention on Outcomes of Early-Stage Schizophrenia

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