Early Detection and Intervention Evaluation for individuals at high risk of psychosis 2
| ISRCTN | ISRCTN56283883 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56283883 |
| Secondary identifying numbers | MRC ref: G0500264 |
- 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
Not provided at time of registration
Contact information
Prof Anthony Morrison
Scientific
Scientific
School of Psychological Sciences
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
Study information
| Study design | Single-blind multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: http://www.psych-sci.manchester.ac.uk/edie2/referral/leaflets/ |
| Scientific title | Early detection and psychological intervention for individuals at high risk of psychosis 2 |
| Study acronym | EDIE-2 |
| Study hypothesis | The 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) |
| Condition | Psychosis |
| Intervention | Cognitive 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 type | Other |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/11/2006 |
| Overall study end date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 320 |
| Participant inclusion criteria | Trial 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) |
| Participant exclusion criteria | 1. 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) |
| Recruitment start date | 01/11/2006 |
| Recruitment end date | 31/12/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
School of Psychological Sciences
Manchester
M13 9PL
United Kingdom
M13 9PL
United Kingdom
Sponsor information
University of Manchester (UK)
University/education
University/education
c/o Dr Karen Shaw
Research Office
Christie Building
University of Manchester
Oxford Road
Manchester
M13 9PL
England
United Kingdom
| Website | http://www.manchester.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Government
Medical Research Council (G0500264) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Department of Health (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Results article | results | 05/04/2012 | Yes | No |
