A trial of antipsychotic medication in comparison to cognitive behaviour therapy or a combination of both in adults with psychosis

Completed

• Conditions: Topic: Mental Health Research Network; Subtopic: Schizophrenia, Psychosis; Disease: Schizophrenia, Psychosis; Mental and Behavioural Disorders; Schizophrenia

• Registration Number: ISRCTN06022197
• Lead Sponsor: Greater Manchester West Mental Health NHS Foundation Trust (UK)

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29605187

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-20
• Study Completion: 2017-04-01
• Last Update Posted: 7 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Current inclusion criteria as of 25/07/2014:
1. In contact with mental health care services (under the care of a consultant)
2. Either meet ICD-10 criteria for schizophrenia, schizoaffective disorder or delusional disorder or meet entry criteria for an Early Intervention for Psychosis service (operationally defined using PANSS) in order to allow for diagnostic uncertainty in early phases of psychosis
3. Aged 16+
4. Competent and willing to provide written, informed consent
5. Score at least 4 on PANSS delusions or hallucinations or at least 5 on Suspiciousness/Grandiosity
6. Help seeking

Previous inclusion criteria:
1. Aged 18+
2. In contact with mental health services
3. Competent to provide written, informed consent.
4. Either meet ICD-10 criteria for schizophrenia, schizoaffective disorder or delusional disorder or meet entry criteria for an Early Intervention for Psychosis service (operationally defined using PANSS) in order to allow for diagnostic uncertainty in early phases of psychosis
5. Score at least 4 on PANSS delusions or hallucinations or at least 5 on suspiciousness/grandiosity
6. Help seeking

Exclusion Criteria

Current exclusion criteria as of 25/07/2014:
1. Primary diagnosis of alcohol/substance misuse
2. Moderate or severe learning disability
3. Score 5+ on PANSS conceptual disorganisation
4. Non-English speaking
5. Current receipt of structured CBT from a qualified psychologist in accordance with NICE guideline recommendations (as opposed to more generic psychosocial interventions) OR receipt of antipsychotics, OR receipt of either within the past 3 months.
6. Immediate risk to self or others
7. Organic Impairment

Previous exclusion criteria:
1. Primary diagnosis of alcohol/substance dependence
2. Moderate or severe learning disability
3. Score 5+ on PANSS conceptual disorganisation
4. Non-English speaking
5. Current receipt of structured CBT or APs, or receipt within the last 3 months
6. Inpatient
7. Immediate risk to self or others
8. Organic Impairment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS); Timepoint(s): 6 weeks, 12 weeks, 24 weeks, 52 weeks

Secondary Outcome Measures

Name	Time	Method
1. Clinical Global Impression scales (CGI); Timepoint(s): 6 weeks, 12 weeks, 24 weeks, 52 weeks<br>2. Hospital Anxiety and Depression Scale (HADS); Timepoint(s): 24 weeks, 52 weeks<br>3. Personal and social performance scale (PSP); Timepoint(s): 24 weeks, 52 weeks<br>4. Questionnaire about the process of Recovery (QPR); Timepoint(s): 24 weeks, 52 weeks<br>5. WHOQOL- quality of life; Timepoint(s): 6 weeks, 12 weeks, 24 weeks and 52 weeks