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Integrated treatment vs. treatment-as-usual for recent onset schizophrenia; 12 year follow-up on a randomized controlled trial.

ABSTRACT: The aim of this study is to compare the 12-year follow-up effects on in- and outpatient services of 2 years of integrated treatment for recent-onset schizophrenia versus treatment as usual in a randomized controlled trial.50 patients aged 18-35 years were randomized to Integrated Treatment (IT) (N?=?30) or Treatment-as-Usual (TAU) (N?=?20) for two years. TAU comprised optimal pharmacotherapy and outreach assertive treatment, while IT also included cognitive-behavioural family treatment, skills training, strategies for residual psychotic and non-psychotic problems and home-based crisis management.There were no differences in number of days in hospital, time to readmission, number of admittances to psychiatric wards, number of involuntarily psychiatric admissions or number of outpatient contacts over a period of 12 years following the initial 2-year treatment trial. Fewer patients in the IT group were, however, involuntary admitted to hospital in the period.The intensive two-year psychosocial intervention seemed to have little long-term effects on use of in- and outpatient services.Current Controlled Trials: NCT00184509.

SUBMITTER: Sigrunarson V

PROVIDER: S-EPMC3733816 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature

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Integrated treatment vs. treatment-as-usual for recent onset schizophrenia; 12 year follow-up on a randomized controlled trial.

Sigrúnarson Víðir V Gråwe Rolf W RW Morken Gunnar G

BMC psychiatry 20130730

<h4>Background</h4>The aim of this study is to compare the 12-year follow-up effects on in- and outpatient services of 2 years of integrated treatment for recent-onset schizophrenia versus treatment as usual in a randomized controlled trial.<h4>Methods</h4>50 patients aged 18-35 years were randomized to Integrated Treatment (IT) (N = 30) or Treatment-as-Usual (TAU) (N = 20) for two years. TAU comprised optimal pharmacotherapy and outreach assertive treatment, while IT also included cognitive-beh ...[more]

PMID: 23898805

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Project description:ImportanceThe OPUS 20-year follow-up is the longest follow-up of a randomized clinical trial testing early intervention services (EIS) among individuals with first-episode schizophrenia spectrum disorder.ObjectiveTo report on long-term associations of EIS compared with treatment as usual (TAU) for first-episode schizophrenia spectrum disorder.Design, setting, and participantsA total of 547 individuals were included in this Danish multicenter randomized clinical trial between January 1998 and December 2000 and allocated to early intervention program group (OPUS) or TAU. Raters who were blinded to the original treatment performed the 20-year follow-up. A population-based sample aged 18 to 45 years with first-episode schizophrenia spectrum disorder were included. Individuals were excluded if they were treated with antipsychotics (>12 weeks prior to randomization), had substance-induced psychosis, had mental disability, or had organic mental disorders. Analysis took place between December 2021 and August 2022.InterventionsEIS (OPUS) consisted of 2 years of assertive community treatment including social skill training, psychoeducation, and family involvement by a multidisciplinary team. TAU consisted of the available community mental health treatment.Main outcomes and measuresPsychopathological and functional outcomes, mortality, days of psychiatric hospitalizations, number of psychiatric outpatient contacts, use of supported housing/homeless shelters, symptom remission, and clinical recovery.ResultsOf 547 participants, 164 (30%) were interviewed at 20-year follow-up (mean [SD] age, 45.9 [5.6] years; 85 [51.8%] female). No significant differences were found between the OPUS group compared with the TAU group on global functional levels (estimated mean difference, -3.72 [95% CI, -7.67 to 0.22]; P = .06), psychotic symptom dimensions (estimated mean difference, 0.14 [95% CI, -0.25 to 0.52]; P = .48), and negative symptom dimensions (estimated mean difference, 0.13 [95% CI, -0.18 to 0.44]; P = .41). The mortality rate was 13.1% (n = 36) in the OPUS group and 15.1% (n = 41) in the TAU group. Likewise, no differences were found 10 to 20 years after randomization between the OPUS and TAU groups on days of psychiatric hospitalizations (incidence rate ratio, 1.20 [95% CI, 0.73-1.20]; P = .46) or number of outpatient contacts (incidence rate ratio, 1.20 [95% CI, 0.89-1.61]; P = .24). Of the entire sample, 53 participants (40%) were in symptom remission and 23 (18%) were in clinical recovery.Conclusions and relevanceIn this follow-up study of a randomized clinical trial, no differences between 2 years of EIS vs TAU among individuals with diagnosed schizophrenia spectrum disorders at 20 years were found. New initiatives are needed to maintain the positive outcomes achieved after 2 years of EIS and furthermore improve very long-term outcomes. While registry data was without attrition, interpretation of clinical assessments are limited by high attrition rate. However, this attrition bias most likely confirms the lack of an observed long-term association of OPUS with outcomes.Trial registrationClinicalTrials.gov Identifier: NCT00157313.

Project description:Study questionWhat is the long-term impact of presumed gonadotoxic treatment during childhood on the patient's testicular function at adulthood?Summary answerAlthough most patients showed low testicular volumes and some degree of reproductive hormone disruption 12.3 (2.3-21.0) years after gonadotoxic childhood therapy, active spermatogenesis was demonstrated in the semen sample of 8 out of the 12 patients.What is known alreadyIn recent decades, experimental testicular tissue banking programmes have been set up to safeguard the future fertility of young boys requiring chemo- and/or radiotherapy with significant gonadotoxicity. Although the risk of azoospermia following such therapies is estimated to be high, only limited long-term data are available on the reproductive potential at adulthood.Study design size durationThis single-centre prospective cohort study was conducted between September 2020 and February 2023 and involved 12 adult patients.Participants/materials setting methodsThis study was carried out in a tertiary care centre and included 12 young adults (18.1-28.3 years old) who had been offered testicular tissue banking prior to gonadotoxic treatment during childhood. All patients had a consultation and physical examination with a fertility specialist, a scrotal ultrasound to measure the testicular volumes and evaluate the testicular parenchyma, a blood test for assessment of reproductive hormones, and a semen analysis.Main results and the role of chanceTesticular tissue was banked prior to the gonadotoxic treatment for 10 out of the 12 included patients. Testicular volumes were low for 9 patients, and 10 patients showed some degree of reproductive hormone disruption. Remarkably, ongoing spermatogenesis was demonstrated in 8 patients at a median 12.3 (range 2.3-21.0) years post-treatment.Limitations reasons for cautionThis study had a limited sample size, making additional research with a larger study population necessary to verify these preliminary findings.Wider implications of the findingsThese findings highlight the need for multicentric research with a larger study population to establish universal inclusion criteria for immature testicular tissue banking.Study funding/competing interestsThis study was conducted with financial support from the Research Programme of the Research Foundation-Flanders (G010918N), Kom Op Tegen Kanker, and Scientific Fund Willy Gepts (WFWG19-03). The authors declare no competing interests.Trial registration numberNCT04202094; https://clinicaltrials.gov/ct2/show/NCT04202094?id=NCT04202094&draw=2&rank=1 This study was registered on 6 December 2019, and the first patient was enrolled on 8 September 2020.

Dataset Information

Integrated treatment vs. treatment-as-usual for recent onset schizophrenia; 12 year follow-up on a randomized controlled trial.

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Integrated treatment vs. treatment-as-usual for recent onset schizophrenia; 12 year follow-up on a randomized controlled trial.

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