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Clinical Trials/ISRCTN06022197
ISRCTN06022197
Completed
N/A

A pilot study of a randomised controlled trial of antipsychotic medication in comparison to cognitive behaviour therapy and a combined treatment in adults with psychosis

Greater Manchester West Mental Health NHS Foundation Trust (UK)0 sites75 target enrollmentMarch 20, 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Topic: Mental Health Research Network
Sponsor
Greater Manchester West Mental Health NHS Foundation Trust (UK)
Enrollment
75
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Registry
who.int
Start Date
March 20, 2014
End Date
April 1, 2017
Last Updated
7 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Greater Manchester West Mental Health NHS Foundation Trust (UK)

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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