Psychosis Mental and Behavioural Disorders
Conditions
Interventions
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 the
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 inv
Sponsors
University of Manchester (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed