Cognitive behavioural therapy (CBT) for people with psychosis not taking antipsychotic medication: a randomised controlled trial
ISRCTN | ISRCTN29607432 |
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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
Scientific
Psychology Department
Prestwich Hospital
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
tony.morrison@manchester.ac.uk |
Study information
Study design | Multicentre randomised interventional treatment trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | 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 study start date | 15/02/2010 |
Completion date | 15/02/2013 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | Planned sample size: 80; UK sample size: 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Psychology Department
Manchester
M25 3BL
United Kingdom
M25 3BL
United Kingdom
Sponsor information
Greater Manchester West Mental Health NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Trust Headquarters
Bury New Road
Prestwich
Manchester
M25 3BL
England
United Kingdom
Website | http://www.gmw.nhs.uk |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 19/04/2014 | Yes | No |