MedPath

A pilot safety and acceptability trial of moderated on-line social therapy (MOST) for first-episode psychosis.

Not Applicable
Active, not recruiting
Conditions
First Episode Psychosis
Mental Health - Psychosis and personality disorders
Registration Number
ACTRN12612000512820
Lead Sponsor
Helen Macpherson Smith Trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Active, not recruiting
Sex
All
Target Recruitment
20
Inclusion Criteria

(a) a first episode of a DSM-IV psychotic disorder or mood disorder with psychotic features; (b) aged 15-25 years inclusive; (c) less than or equal to 6 months treatment with an antipsychotic medication prior to registration with the early psychosis service; (d) remission on positive symptoms of psychosis which will be defined as 4 weeks or more of scores of 3 (mild) or below on the subscale items hallucinations, unusual thought disorder, conceptual disorganization, and suspiciousness on the expanded version of the Brief Psychiatric Rating Scale (BPRS). Additional inclusion criteria to ensure low level of risk within MOST include: (e) low aggressiveness which will be defined by a score of 5 or below (with the exception of evidence of threat to others) on the hostility subscale of the expanded version of the BPRS for the month prior to study entry; and, (f) low suicidal risk defined as a score of 4 or below on the suicidality subscale for the month preceding study entry.

Exclusion Criteria

(a) intellectual disability; (b) inability to converse in, or read English; (c) participation in previous CBT or pharmacological trials for psychosis; (d) a DSM-IV diagnosis of either antisocial personality disorder (ASPD) or borderline personality disorder (BPD); (e) pregnancy; (f) medical conditions requiring high level of care; (g) presence of acute psychotic symptoms above a mild level; (h) presence of moderate or above levels of suicidality or hostility.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Acceptability of the system will be considered achieved if 10 of the 20 participants log on more than once per week across each of the four weeks during the 1-month of the pilot.[Follow-up assessment post-trial (1 month follow-up)];The pilot will be considered to indicate safety of the Horyzons system if: (i) all participants report feeling adequately supported by moderators via the semi-structured interview, (ii) two or less participants experience relapse in psychosis during the 1 month of the pilot; (iii) no participants deliberately self harm during the course of the pilot; and (iii) if there are no unlawful entries into the Horyzons system.[Follow-up assessment post-trial (1 month follow-up)]
Secondary Outcome Measures
NameTimeMethod
il[Nil]
© Copyright 2025. All Rights Reserved by MedPath