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Cognitive behavioural therapy (CBT) for people with psychosis not taking antipsychotic medication: a randomised controlled trial
ISRCTN ISRCTN29607432
DOI 10.1186/ISRCTN29607432
ClinicalTrials.gov identifier
EudraCT number
Public title Cognitive behavioural therapy (CBT) for people with psychosis not taking antipsychotic medication: a randomised controlled trial
Scientific title
Acronym ACTION (Assessment of Cognitive Therapy Instead of Neuroleptics)
Serial number at source 7991
Study hypothesis Comparing cognitive behavioural therapy (CBT) with treatment as usual for people with psychosis who are not taking antipsychotic medication
Lay summary Not provided at time of registration
Ethics approval MREC approved (ref: 09/H1014/53)
Study design Multicentre randomised interventional treatment trial
Countries of recruitment United Kingdom
Disease/condition/study domain Topic: Mental Health Research Network; Subtopic: Psychosis; Disease: Psychosis
Participants - inclusion criteria Participants in all phases will:
1. Be in contact with mental health services
2. Have an identified care coordinator
3. Either meet International Classification of Diseases-10 (ICD-10) criteria for schizophrenia, schizoaffective disorder or delusional disorder or meet entry criteria for an early intervention for psychosis service (operationally defined using Positive And Negative Symptom Scales [PANSS]) in order to allow for diagnostic uncertainty in early phases of psychosis
4. Either have at least 6 months without antipsychotic medication and experiencing continuing symptoms OR never have received antipsychotics and be currently refusing
5. Score at least 4 on PANSS delusions or hallucinations or, score 5 on suspiciousness/persecution, conceptual disorganisation or grandiosity
6. Aged 16 - 65 years, either sex
Participants - exclusion criteria 1. Current receipt of antipsychotic medication
2. Moderate to severe learning disability
3. Organic impairment
4. Non-English speaking (since this would prevent the use of standardised assessment instruments)
5. Inpatient/acute psychiatric care needed
6. Previous CBT for psychosis or, previous CBT for other disorders in the last 2 years
7. Without a care coordinator
8. Any substance dependency
Anticipated start date 15/02/2010
Anticipated end date 15/02/2013
Status of trial Completed
Patient information material
Target number of participants Planned sample size: 80; UK sample size: 80
Interventions Cognitive therapy based on the cognitive model outlined by Morrison (2001).

Follow up length: 18 months
Study entry: single randomisation only
Primary outcome measure(s) PANSS, measured at all assessments
Secondary outcome measure(s) 1. Psychotic Symptom Rating Scales (PSYRATS), measured at all assessments
2. Questionnaire about the Process of Recovery (QPR), measured at all assessments
Sources of funding National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF)
Trial website
Publications 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24508320
Contact name Mr  Anthony  Morrison
  Address Psychology Department
Prestwich Hospital
Bury New Road
Prestwich
  City/town Manchester
  Zip/Postcode M25 3BL
  Country United Kingdom
  Email tony.morrison@manchester.ac.uk
Sponsor Greater Manchester West Mental Health NHS Foundation Trust (UK)
  Address Trust Headquarters
Bury New Road
Prestwich
  City/town Manchester
  Zip/Postcode M25 3BL
  Country United Kingdom
  Sponsor website: http://www.gmw.nhs.uk
Date applied 21/10/2010
Last edited 11/02/2014
Date ISRCTN assigned 21/10/2010
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