A Randomised Control Trial of people with psychosis taking Risperdal Consta compared to people with psychosis taking Risperdal Consta and receiving Collaborative Therapy (a psychoeducational program) in a naturalistic setting

Not Applicable

Recruiting

• Conditions: Psychosis; Mental Health - Psychosis and personality disorders

• Registration Number: ACTRN12609000317291
• Lead Sponsor: Prof. David Castle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Age 18 – 65 years
Currently taking Risperdal Consta (must have been on consta for a minimum of 6 weeks).
Able to converse in English without an interpreter
Absence of developmental disability or amnestic syndrome that would impair ability to learn from the intervention.

Exclusion Criteria

Age under 18 years
Not taking Risperdal Consta
Unable to converse in English without an interpreter
Presence of developmental disability or amnestic syndrome that would impair ability to learn from the intervention

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment compliance measured by an clinical file audit.[A 12 month period post baseline]

Secondary Outcome Measures

Name	Time	Method
Psychiatric Symptoms measured by Positive and Negative Symptom Scale (PANSS)Depression, Anxiety and Stress Scale (DASS)[Baseline, 3,6 9 and 12 month.];Side effect profile measured by Liverpool University neuroleptic side-effect rating scale (LUNSERS)[Baseline, 3,6 9 and 12 month.];Measure of Psychosocial Function using the<br>Occupational Self Assessment (OSA) and the<br>Personal Wellbeing Index (PWI)[Baseline, 3,6 9 and 12 month.];Service Utilisation using the Diagnostic Interview for Psychosis (DIP)service utilisation module.[baseline and 12 months only]