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

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. 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. 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.