Plain English Summary

Not provided at time of registration

Trial website

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

http://www.gmw.nhs.uk

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

  1. 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.

Editorial Notes