REDUCE: Does Antipsychotic Dose Reduction Lead to Better Functional Recovery in First Episode Psychosis: A Randomised Controlled Trial

Intervention

Intervention code Treatment: Other , Behaviour

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 the .... 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.
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Comparison

Control group Dose comparison

Antipsychotic Maintenance Treatment (AMTx) group: Participants will continue to receive medication as indicated, concordant with the Australian Clinical Practice Guidelines for FEP for the 15-18 month treatment phase of the study]. These guidelines recommend the use of the lowest effective dose of atypical antipsychotics. . 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 trea .... Antipsychotic Maintenance Treatment (AMTx) group: Participants will continue to receive medication as indicated, concordant with the Australian Clinical Practice Guidelines for FEP for the 15-18 month treatment phase of the study]. These guidelines recommend the use of the lowest effective dose of atypical antipsychotics. . 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 AMT group will also receive the same level/duration of EBIRT as the DRS Group All trial participants will have access to all components of treatment at EPPIC, such as psychiatric care, case management, psychosocial program, acute inpatient care and outreach as clinically indicated. 40 healthy controls aged 15-25 years (inclusive), living in the EPPIC catchment, and have no history of mental illness, neurological condition or antipsychotic medication treatment will also be recruited. They will be scanned, cognitively assessed and have physical health indicators measured (except bloods) at the same four time points as the DRS+ and AMTx+ groups (baseline, 9-months, 15-months and 24 months). This will provide objective control data to determine whether there are physical health, brain volume and neural activation or cognition changes and if they are related to illness, medication or normal development.
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Outcomes

Outcome: Social and Occupational functioning assessed using the Social and Occupational Functioning Scale (SOFAS).
Timepoint: 24 months