Contact information
Type
Scientific
Primary contact
Mr Anthony Morrison
ORCID ID
Contact details
Psychology Department
Prestwich Hospital
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
tony.morrison@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7991
Study information
Scientific title
Acronym
ACTION (Assessment of Cognitive Therapy Instead of Neuroleptics)
Study hypothesis
Comparing cognitive behavioural therapy (CBT) with treatment as usual for people with psychosis who are not taking antipsychotic medication
Ethics approval
MREC approved (ref: 09/H1014/53)
Study design
Multicentre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Phase II/III
Drug names
Primary outcome measures
PANSS, measured at all assessments
Secondary outcome measures
1. Psychotic Symptom Rating Scales (PSYRATS), measured at all assessments
2. Questionnaire about the Process of Recovery (QPR), measured at all assessments
Overall trial start date
15/02/2010
Overall trial end date
15/02/2013
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 80; UK sample size: 80
Participant 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
Recruitment start date
15/02/2010
Recruitment end date
15/02/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Psychology Department
Manchester
M25 3BL
United Kingdom
Sponsor information
Organisation
Greater Manchester West Mental Health NHS Foundation Trust (UK)
Sponsor details
Trust Headquarters
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24508320
Publication citations
-
Results
Morrison AP, Turkington D, Pyle M, Spencer H, Brabban A, Dunn G, Christodoulides T, Dudley R, Chapman N, Callcott P, Grace T, Lumley V, Drage L, Tully S, Irving K, Cummings A, Byrne R, Davies LM, Hutton P, Cognitive therapy for people with schizophrenia spectrum disorders not taking antipsychotic drugs: a single-blind randomised controlled trial., Lancet, 2014, 383, 9926, 1395-1403, doi: 10.1016/S0140-6736(13)62246-1.