scholarly journals REDIRECT: cluster randomised controlled trial of GP training in first-episode psychosis

2009 ◽  
Vol 59 (563) ◽  
pp. e183-e190 ◽  
Author(s):  
Helen Lester ◽  
Max Birchwood ◽  
Nick Freemantle ◽  
Maria Michail ◽  
Lynda Tait
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
First Episode Psychosis ◽  
First Episode ◽  
Cluster Randomised ◽  
Episode Psychosis ◽  
Randomised Controlled ◽  
Gp Training

scholarly journals HORYZONS trial: protocol for a randomised controlled trial of a moderated online social therapy to maintain treatment effects from first-episode psychosis services

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e024104 ◽  
Author(s):  
Mario Alvarez-Jimenez ◽  
Sarah Bendall ◽  
Peter Koval ◽  
Simon Rice ◽  
Daniela Cagliarini ◽  
...  
Keyword(s):  
Social Media ◽  
Randomised Controlled Trial ◽  
Social Functioning ◽  
Controlled Trial ◽  
First Episode Psychosis ◽  
First Episode ◽  
Online Social Media ◽  
Regular Care ◽  
Episode Psychosis ◽  
Randomised Controlled

IntroductionSpecialised early intervention services have demonstrated improved outcomes in first-episode psychosis (FEP); however, clinical gains may not be sustained after patients are transferred to regular care. Moreover, many patients with FEP remain socially isolated with poor functional outcomes. To address this, our multidisciplinary team has developed a moderated online social media therapy (HORYZONS) designed to enhance social functioning and maintain clinical gains from specialist FEP services. HORYZONS merges: (1) peer-to-peer social networking; (2) tailored therapeutic interventions; (3) expert and peer-moderation; and (4) new models of psychological therapy (strengths and mindfulness-based interventions) targeting social functioning. The aim of this trial is to determine whether following 2 years of specialised support and 18-month online social media-based intervention (HORYZONS) is superior to 18 months of regular care.Methods and analysisThis study is a single-blind randomised controlled trial. The treatment conditions include HORYZONS plus treatment as usual (TAU) or TAU alone. We recruited 170 young people with FEP, aged 16–27 years, in clinical remission and nearing discharge from Early Psychosis Prevention and Intervention Centre, Melbourne. The study includes four assessment time points, namely, baseline, 6-month, 12-month and 18-month follow-up. The study is due for completion in July 2018 and included a 40-month recruitment period and an 18-month treatment phase. The primary outcome is social functioning at 18 months. Secondary outcome measures include rate of hospital admissions, cost-effectiveness, vocational status, depression, social support, loneliness, self-esteem, self-efficacy, anxiety, psychological well-being, satisfaction with life, quality of life, positive and negative psychotic symptoms and substance use. Social functioning will be also assessed in real time through our Smartphone Ecological Momentary Assessment tool.Ethics and disseminationMelbourne Health Human Research Ethics Committee (2013.146) provided ethics approval for this study. Findings will be made available through scientific journals and forums and to the public via social media and the Orygen website.Trial registration numberACTRN12614000009617; Pre-results.

scholarly journals A Multicentre, Randomised, Controlled Trial of a Combined Clinical Treatment for First-Episode Psychosis

2021 ◽  
Vol 18 (14) ◽  
pp. 7239
Author(s):  
Itxaso González-Ortega ◽  
Patricia Vega ◽  
Enrique Echeburúa ◽  
Susana Alberich ◽  
Jessica Fernández-Sevillano ◽  
...  
Keyword(s):  
Early Intervention ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
First Episode Psychosis ◽  
Clinical Treatment ◽  
Post Treatment ◽  
Psychotic Symptoms ◽  
First Episode ◽  
Episode Psychosis ◽  
Randomised Controlled

Introduction: There is evidence that early intervention contributes to improving the prognosis and course of first-episode psychosis (FEP). However, further randomised treatment clinical trials are needed. Objectives: The aim of this study was to compare the efficacy of a combined clinical treatment involving Cognitive Behavioural Therapy (CBT) as an adjunctive to treatment-as-usual (TAU) (CBT+TAU) versus TAU alone for FEP. Patients and methods: In this multicentre, single-blind, randomised controlled trial, 177 participants were randomly allocated to either CBT+TAU or TAU. The primary outcome was post-treatment patient functioning. Results: The CBT+TAU group showed a greater improvement in functioning, which was measured using the Global Assessment Functioning (GAF) and Functioning Assessment Short Test (FAST), compared to the TAU group post-treatment. The CBT+TAU participants exhibited a greater decline in depressive, negative, and general psychotic symptoms; a better awareness of the disease and treatment adherence; and a greater increase in brain-derived neurotrophic factor levels than TAU participants. Conclusions: Early intervention based on a combined clinical treatment involving CBT as an adjunctive to standard treatment may improve clinical and functional outcomes in FEP.

scholarly journals The Early Youth Engagement in first episode psychosis (EYE-2) study: pragmatic cluster randomised controlled trial of implementation, effectiveness and cost-effectiveness of a team-based motivational engagement intervention to improve engagement

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Kathryn Greenwood ◽  
Rebecca Webb ◽  
Jenny Gu ◽  
David Fowler ◽  
Richard de Visser ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Young People ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
First Episode ◽  
Youth Engagement ◽  
Cluster Randomised ◽  
Episode Psychosis ◽  
Randomised Controlled ◽  
Engagement Intervention

Abstract Background Early Intervention in Psychosis (EIP) services improve health outcomes for young people with psychosis in the medium–long term, but 25% of young people disengage in the first 12 months with costs to their mental health, families, society and the NHS. This study will evaluate the effectiveness, cost-effectiveness and implementation of a team-based motivational Early Youth Engagement (EYE-2) intervention. Method The study design is a cluster randomised controlled trial (RCT) with economic evaluation, comparing the EYE-2 intervention + standardised EIP service to standardised EIP service alone, with randomisation at the team level. A process evaluation will evaluate the delivery of the intervention qualitatively and quantitatively across contexts. The setting is 20 EIP teams in 5 sites: Manchester, South London, East Anglia, Thames Valley and Hampshire. Participants are young people (14–35 years) with first episode psychosis, and EIP staff. The intervention is the team-based motivational engagement (EYE-2) intervention, delivered alongside standardised EIP services, and supported by additional training, website, booklets and social groups. The comparator is the standardised EIP service. Both interventions are delivered by EIP clinicians. The primary outcome is time to disengagement (time in days from date of allocation to care coordinator to date of last contact following refusal to engage with EIP service, or lack of response to EIP contact for a consecutive 3-month period). Secondary outcomes include mental and physical health, deaths, social and occupational function, recovery, satisfaction and service use at 6, 12, 18 and 24 months. A 12-month within-trial economic evaluation will investigate cost-effectiveness from a societal perspective and from an NHS perspective. Discussion The trial will provide the first test of an engagement intervention in standardised care, with the potential for significant impact on the mental health and wellbeing of young people and their families, and economic benefits for services. The intervention will be highly scalable, supported by the toolkit including manuals, commissioning guide, training and resources, adapted to meet the needs of the diverse EIP population, and based on an in-depth process evaluation. Trial registration ISRCTN 51629746 prospectively registered 7th May 2019. Date assigned 10th May 2019.

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