Early Detection and Intervention Evaluation for individuals at high risk of psychosis 2

ISRCTN ISRCTN56283883
DOI https://doi.org/10.1186/ISRCTN56283883
Protocol serial number MRC ref: G0500264
Sponsor University of Manchester (UK)
Funders Medical Research Council (G0500264) (UK), Department of Health (UK)
Submission date
03/03/2008
Registration date
29/08/2008
Last edited
29/05/2012
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

Prof Anthony Morrison
Scientific

School of Psychological Sciences
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom

Study information

Primary study designInterventional
Study designSingle-blind multicentre randomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleEarly detection and psychological intervention for individuals at high risk of psychosis 2
Study acronymEDIE-2
Study objectivesThe main hypothesis is that cognitive therapy (CT) will reduce or delay transition to psychosis in people who are at high risk of developing psychosis.

More details can be found at:
http://www.mrc.ac.uk/ResearchPortfolio/Grant/Record.htm?GrantRef=G0500264&CaseId=5270
Ethics approval(s)The Eastern Multicentre Research Ethics Committee approved the study on 3rd October 2005 (ref: 05/MRE05/6)
Health condition(s) or problem(s) studiedPsychosis
InterventionCognitive therapy plus monitoring (Intervention group) vs monitoring alone (Control group).

Intervention group:
CT will be based on a specific cognitive model (French & Morrison, 2004). Cognitive therapy allows an individualised approach within clear boundaries, and incorporates a process of assessment and formulation, which is manualised. The specific interventions are dependent on the individual formulation, but the range of permissible interventions is described in our published manual. Fidelity to the treatment protocol will be ensured by regular supervision of the therapists and assessed by rating tape recordings of sessions using a revised version of the Cognitive Therapy Scale (Dobson, Shaw, & Vallis, 1985). This is a widely-accepted approach to the standardisation of CT, which we have adopted in previous large-scale trials. Participants will receive up to 25 weekly one-hour sessions plus up to four booster sessions.

Control group:
The control condition is treatment as usual plus monitoring, which represents an enhancement over routine care since psychotic symptoms will be detected earlier than in usual practice and appropriate treatment referrals made (the reduction of duration of untreated psychosis is a national target for the NHS, and our control condition will achieve this). Monitoring will identify untreated psychosis and any risks to self or others that require immediate action. In addition, the monitoring group will also receive two standardised components of care: ensuring that the patient has a General Practitioner and encouraging regular contact with them (since several of our pilot study patients did not have a GP at intake); and development of a crisis card providing contact details for appropriate local sources of help in a psychiatric emergency. Monitoring will not include liaison with a clinical team, should one be involved, except where risk issues necessitate this. The use of enhanced standard care as a control has the advantages of (i) controlling at least in part for non-specific contact and (ii) ensuring that all trial participants derive some benefit from the trial (this expected benefit was included in the power calculations), therefore ensuring that it conforms to the highest ethical standards.

All participants will be monitored by a monthly assessment for the first six months and then every three months for up to two years total.
Intervention typeOther
Primary outcome measure(s)

Comprehensive Assessment of At Risk Mental States (CAARMS) at baseline, every month from Months 1 to 6, then every three months from Month 9 to 24.

Key secondary outcome measure(s)

1. Structured Clinical Interview for DSM-IV at baseline, at transition to psychosis if it occurs (which may be any month), and at the end of participation in study
2. Beck Depression Inventory-FS at baseline, every months from Months 1 to 6, and then every three months from Month 9 to 24
3. Social Interaction and Anxiety Scale at baseline, every month from Months 1 to 6, then every three months from Month 9 to 24
4. EQ-5D at baseline, every months from Months 1 to 6, then every three months from Month 9 to 24
5. Manchester Short Assessment of Quality of Life at baseline, Months 6, 12, 18 and 24
6. Personal Beliefs about Illness Questionnaire at baseline, Months 6, 12, 18 and 24
7. Drug Check at baseline, Months 6, 12, 18 and 24
8. Beliefs About Paranoia Scale at Months 1 and 6
9. Persecution and Deservedness Scale at Months 1 and 6
10. Brief Core Schema Scales at Months 1 and 6
11. Metacognitions Questionnaire (short form) at Months 1 and 6
12. Interpretations of Voices Inventory at Months 1 and 6
13. California Psychotherapy Alliance Scales at Months 1 and 6

We are also recording prescriptions of psychiatric medications, including anti-psychotic medications. Timepoints of assessment: Baseline, every months from Months 1 to 6, then every three months from Month 9 to 24

Completion date31/12/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration320
Key inclusion criteriaTrial entry criteria will be assessed using the Comprehensive Assessment of At-Risk Mental States (CAARMS). Patents must satisfy one of the following to be eligible for inclusion into this study:
1. Brief limited intermittent psychotic symptoms (BLIPS) defined as a score of 6 on any positive item, with symptoms lasting less than one week and resolving without antipsychotic medication
2. Attenuated symptoms (AS), defined as the presence of positive symptoms that score 3-5 and have begun in the last year and which occur at least once per week in the last month
3. State-plus-trait group (SPT), operationally defined by the presence of an at-risk mental state (recent deterioration in function of 30 points or more on the Global Assessment of Functioning) plus either a family history indicated by a first degree relative with a history of any psychotic disorder or a diagnosis of schizotypal personality disorder in the participant

In addition, the patient must fulfil both of the following:
4. Age 14-35
5. Seeking help for symptoms (the latter criterion is necessary to ensure that the provision of treatment to the participants is ethical)
Key exclusion criteria1. Current or previous receipt of antipsychotic medication for more than two days
2. Moderate to severe learning disability
3. Organic impairment
4. Non-English speaking (since this would prevent the use of standardised assessment instruments)
Date of first enrolment01/11/2006
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

School of Psychological Sciences
Manchester
M13 9PL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 05/04/2012 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes
BMC - Part of Springer Nature Springer Nature