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
Secondary identifying numbers 7991
Submission date
21/10/2010
Registration date
21/10/2010
Last edited
11/02/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Anthony Morrison
Scientific

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

Email tony.morrison@manchester.ac.uk

Study information

Study designMulticentre randomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymACTION (Assessment of Cognitive Therapy Instead of Neuroleptics)
Study objectivesComparing 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) studiedTopic: Mental Health Research Network; Subtopic: Psychosis; Disease: Psychosis
InterventionCognitive therapy based on the cognitive model outlined by Morrison (2001).

Follow up length: 18 months
Study entry: single randomisation only
Intervention typeOther
Primary outcome measurePANSS, measured at all assessments
Secondary outcome measures1. Psychotic Symptom Rating Scales (PSYRATS), measured at all assessments
2. Questionnaire about the Process of Recovery (QPR), measured at all assessments
Overall study start date15/02/2010
Completion date15/02/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned sample size: 80; UK sample size: 80
Key inclusion criteriaParticipants 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 criteria1. 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 enrolment15/02/2010
Date of final enrolment15/02/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Psychology Department
Manchester
M25 3BL
United Kingdom

Sponsor information

Greater Manchester West Mental Health NHS Foundation Trust (UK)
Hospital/treatment centre

Trust Headquarters
Bury New Road
Prestwich
Manchester
M25 3BL
England
United Kingdom

Website http://www.gmw.nhs.uk

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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