None listed
Conditions
Brief summary
The proposed study is a single-blind, randomised controlled trial (RCT) comparing two forms of early intervention for psychosis. The proposed interventions are the current model of early intervention for psychosis (i.e., 18 months to 2 years of specialised treatment followed by discharge to standard treatment; FU-ST), and FU-ST in conjunction with a world-first online psychosocial intervention (Horyzons). Patients with first episode psychosis (FEP) will be randomised from between 3 months prior to discharge and discharge from specialised treatment to receive either i) FU-ST, or ii) FU-ST+ Horyzons, for 18 months. The primary hypothesis is that FU-ST+Horyzons participants will show better outcomes than FU-ST participants on social functioning at 18 months follow-up. The secondary hypotheses are that FU-ST+Horyzons participants will show improved outcomes compared with FU-ST on the secondary outcomes of: i) relapse rates; ii) depression; iii) psychological wellbeing, iii) anxiety, iv) social support and social isolation; v) quality of life; vi) satisfaction with life; vii) self-esteem; viii) empowerment; ix) physical health; xi) vocational status; and xii) substance use, over 18 months follow-up. Finally, FU-ST+Horyzons will be more cost-effective than FU-ST at 18 months follow-up. This will be the first study to examine whether an innovative online intervention is an effective strategy for maintaining the clinical benefits beyond discharge of early intervention in first episode psychosis.
Interventions
The intervention for investigation is a world-first on-line system entitled Horyzons, designed with the purpose of maintaining the clinical benefits of early intervention in young people who have experienced first episode psychosis (FEP).
Horyzons has been developed by a multidisciplinary team of clinical psychologists, computer programmers, health informatics experts, web and graphic designers, and professional writers. In accordance with international recommendations, the online system has be
The intervention for investigation is a world-first on-line system entitled Horyzons, designed with the purpose of maintaining the clinical benefits of early intervention in young people who have experienced first episode psychosis (FEP). Horyzons has been developed by a multidisciplinary team of clinical psychologists, computer programmers, health informatics experts, web and graphic designers, and professional writers. In accordance with international recommendations, the online system has been developed iteratively over a 30-month period following participatory design principles through a process of regular feedback and testing with focus groups of stakeholders (i.e. FEP patients and clinicians). Horyzons includes fully functional versions for computer and internet-enabled mobile devices. The Horyzons system comprises a platform for the delivery of a range of evidence-based and interactive psychosocial interventions which are enhanced by a moderated on-line social networking environment. Specifically, Horyzons integrates: i) peer-to-peer on-line social networking; ii) individually tailored interactive psychosocial interventions; and (iii) expert and peer moderation. The psychosocial interventions, based on principles of Positive Psychology, CBT for coping and Mindfulness, psychoeducation target key risk factors and salient domains in the early recovery process including: (a) vocational recovery, (b) early warning signs of relapse (EWS), (c) depression, (d) social anxiety, (e) personal strengths, and (f) substance abuse. Horyzons is a User Driven system. There is no minimum requirement for using Horyzons and participants can use which ever parts of the system they choose. Expert moderators will help users make the most of the system and encourage a positive, supportive and safe experience. To improve adherence with and minimise attrition from Horyzons, moderation will be informed by self-determination theory (SDT) which is concerned with supporting our natural or intrinsic tendencies to behave in effective and healthy ways. All user activity will be captured through the Horyzons platform and this data will form part of the analysis. Patients with FEP randomised to the intervention group will receive access to Horyzons for 18 months from randomisation plus standard treatment at discharge. This will be the first study to examine whether an innovative online intervention is an effective strategy for the maintenance of specialised treatment effects in FEP.
Sponsors
Orygen, The National Centre of Excellence in Youth Mental Health
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to 27 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria for the study will be: (i) a first episode of a DSM-IV psychotic disorder or mood disorder with psychotic features (ii) aged 16-27 years inclusive (iii) less than or equal to 6 months treatment with an antipsychotic medication prior to registration with EPPIC (iv) remission of positive symptoms of psychosis* (v) less than or equal to 3 months to the due date of discharge from EPPIC (vi) low aggressiveness** (vii) moderate or lower suicidal risk*** (viii) able to nominate an emergency contact *Remission of positive symptoms of psychosis is defined as 4 weeks or more of scores of 3 (mild) or below on the Positive and Negative Syndrome Scale (PANSS) items: (i) conceptual disorganization (P2); (ii) unusual thought content (G9); score of 4 or below with no functional impairment on PANSS items: (iii) hallucinatory behaviour (P3); (iv) delusions (P1); **Low aggressiveness is defined as a score of 3 or below on the poor impulse control item of the PANSS for the month prior to study entry ***Moderate or lower suicidal risk is defined as a score of 4 or below on the Brief Psychiatric Rating Scale - expanded version (BPRS) suicidality subscale for the month preceding study entry.
Exclusion criteria
Exclusion criteria for the study will be: (i) intellectual disability* (ii) inability to converse in, or read English. (iii)DSM-IV diagnosis of antisocial personality disorder (ASPD) (iv) DSM-IV diagnosis of borderline personality disorder (BPD) with the additional criteria that the BPD features cause interpersonal difficulties in the treatment environment
Outcome results
None listed