Does Antipsychotic Dose Reduction in combination with Evidence-Based Intensive Recovery Treatment (EBIRT) Lead to Better Functional Recovery in First Episode Psychosis: A Randomised Controlled Trial

INTERVENTION: Evidence‐Based Intensive Recovery Treatment (EBIRT) combines two well‐validated and manualised psychosocial interventions; Individual Placement and Support (IPS) for vocational recovery and Cognitive Behaviour Therapy (CBT) for Relapse Prevention. IPS is (a) focussed upon competitive employment, education or training as an outcome; and (b) focussed upon immediate job/education searching. EBIRT will be delivered in two phases; a 9‐month intensive phase which entails two sessions of individual therapy per week for 9‐months, followed by a 6‐9 month (dependent on tenure remaining in service)‐ maintenance/monitoring phase in which individual therapy sessions will be delivered every 4‐6 weeks. EBIRT will be provided by a therapist trained in CBT and is comprised of six or more modules of therapy delivered over the 9 month intensive period. Each CBT session will be for approximately 1 hour in length and will aimed to be delivered twice a week, but will be dependent on the participants availability. There is no minimum required session per week.. IPS will be delivered separately by a trained vocational support worker. The aim will be for IPS to be delivered weekly but this is flexible and will be dependent on the individuals vocational support requirements. The six phases of EBIRT intervention include: (1) initiation of vocational intervention (2) formulation and agenda setting; including vocational goal setting; (3) engagement and assessment for recovery and risk for relapse; (4) psychoeducation with a focus on relapse; (5) early warning signs and relapse planning – will also involve family members with participant’s consent; and, treatment and progress review (6). Additional optional modules may be drawn upon depending on case formulation and clinical determination in collaboration with the participant include: substance abuse, stress management, and co‐morbid anxiety and depression at the investigator’s discretion. In tandem with EBIRT, participants will be randomly assigned following baseline assessment to either the DRS or AMTx treatment conditions. Treatment fidelity will be ensured via the following procedures: (a) treatment manuals detailing treatment procedures; (b) ongoing weekly group supervision providing feedback with clinical supervisors; and (c) audio‐taping of EBIRT therapy sessions for all participants, unless they have explicitly stated they do not wish to be record. These recordings will be independently rated using previously developed fidelity measures. CONDITION: First Episode Psychosis PRIMARY OUTCOME: Social and Occupational functioning assessed using the Social and Occupational Functioning Scale (SOFAS). INCLUSION CRITERIA: 1. Current client of EPPIC. 2. A confirmed diagnosis of first episode of a DSM 5 psychotic disorder or mood disorder with psychotic features as determined by the Structured Clinical Interview (Modules A‐D) for DSM‐5 Axis I Disorders, patient version (SCID‐RV); 3. Aged 15‐25 years (inclusive). 4. Greater than 3 months of remission on positive symptoms of psychosis in the first year of antipsychotic treatment at EPPIC (a score of less than 3 (mild) on the hallucinations, unusual thought disorder, conceptual disorganisation, and suspiciousness subscale items of the Brief Psychiatric Rating Scale (exBPRS). 5. Low suicidality defined as a score of 4 or below on the exBPRS sustained for the past 1‐month period prior to baseline. 6. The young person is willing for their carer to be informed about the study and will have at least weekly contact with their carer. 7. Ability to provide written informed consent. Where participants are u Dose Reduction Strategy (DRS+) group: Participants who are randomised to this arm of the trial will be offered a gradual dose reduction of their antipsychotic medication. Medication will be tapered under close medical supervision over 3‐months after allocation to the DRS group to avoid relapse due to abrupt discontinuation. The rate of tapering will be a 25% dose reduction (or as near to 25% as the medication allows) of the pre‐reduction dose every month for 3 months, If clinically safe as determined by the Early Psychosis Prevention and Intervention Centre (EPPIC) treating team. If discontinuation criteria (psychotic relapse or exacerbation) is met at any time throughout the study, the minimum therapeutic dose will be continued or reinstated. As per routine guidelines, the young person’s treating doctor will review their treatment options with them at discharge from EPPIC, this will coincide with their end of treatment. The participant will then remain on the last dose for the remainder of EBIRT after the 3 months of DRS unless clinically indicated, in which case anti‐psychotic medication can be reinstated. This will be done in consultation with the Principal Investigator, the Consultant Psychiatrist and the participants treating team. SECONDARY OUTCOME: Brain volumes/activity is a composite secondary outcome‐ Brain volume will be quantified in both treatment groups and healthy controls by high‐resolution magnetic resonance imaging (MRI). In addition to structural MRI imaging, functional resting state will also be performed. Cognitive functioning will assessed with neurocognitive tests (including the Brief Assessment of Cognition in Schizophrenia (BACS) will be used to assess neuropsychological functioning in all groups. Physical health is a composite secondary outcome and will be measured by clinical blood analysis evaluating glucose, haemoglobin A1C, and lipid levels in the treatment groups only. Blood pressure, weight, height and waist circumference will also be recorded. Remission and relapse rates of positive symptoms is a composite secondary outcome and will be assessed using the Brief Psychiatric Rating Scale (exBPRS) in treatment groups only. Remission of negative symptoms will be assessed using the Scale for Assessment of Negative Symptoms (SANS).