Cognitive behavioural therapy (CBT) for people with psychosis not taking antipsychotic medication: a randomised controlled trial

ISRCTN	ISRCTN29607432
DOI	https://doi.org/10.1186/ISRCTN29607432
Protocol serial number	7991
Sponsor	Greater Manchester West Mental Health NHS Foundation Trust (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Anthony Morrison
Scientific

Psychology Department
Prestwich Hospital
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom

Email	tony.morrison@manchester.ac.uk

Primary study design	Interventional
Study design	Multicentre randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ACTION (Assessment of Cognitive Therapy Instead of Neuroleptics)
Study objectives	Comparing cognitive behavioural therapy (CBT) with treatment as usual for people with psychosis who are not taking antipsychotic medication
Ethics approval(s)	MREC approved (ref: 09/H1014/53)
Health condition(s) or problem(s) studied	Topic: Mental Health Research Network; Subtopic: Psychosis; Disease: Psychosis
Intervention	Cognitive therapy based on the cognitive model outlined by Morrison (2001). Follow up length: 18 months Study entry: single randomisation only
Intervention type	Other
Primary outcome measure(s)	PANSS, measured at all assessments
Key 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
Completion date	15/02/2013

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	80
Key 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
Key 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
Date of first enrolment	15/02/2010
Date of final enrolment	15/02/2013

Psychology Department

Manchester
M25 3BL
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	19/04/2014		Yes	No