Recovery Training of Emotion and Cognition with Vortioxetine for Depression (RECOVER-D) Study

Participants randomised to have the psychosocial intervention program will receive a personalised treatment stream of the psychosocial training intervention program that is tailored to address their weaknesses. The psychological treatment will target three domains of psychosocial functioning, which when impaired, appear to underlie psychosocial dysfunction in depression. These domains include cognition (e.g. attention, memory), emotion processing (e.g. pessimism), and social cognition (e.g. interpreting social situations). The current treatment will target functioning in these domains with repeated training tasks, following the rationale that therapeutic benefits will arise with psychosocial functioning. The one-on-one intervention will be conducted remotely online using a videoconferencing platform (Zoom) and delivered by trained researchers with a background in psychology. The intervention will have 8 sessions across 8 weeks with 1 session per week. Each session will be between 1 hour and 1.5 hours long. Adherence of the psychological intervention will be monitored through participants attendance of the weekly sessions. Personalised interventions will be tailored to address participants’ weakest domains. Baseline tests will determine weakest area of functioning by evaluating participants’ performance with the THINC-it tool (cognition), verbal fluency task (cognition), the PANAS (emotion) and the WAIS-IV Social Cognition Test (social cognition). Significant weakness in these tests will be defined as performance at least 0.5 standard deviations below the norm. On the basis of individual weaknesses, participants allocated to personalised treatment will be delivered one of four potential treatment streams; (1) high cognition treatment, (2) high emotion treatment, (3) high social cognition treatment, and (4) broad impairment treatment. Participants will be allocated to streams 1, 2 or 3 if their greatest weakness is primarily represented in one of the 3 baseline domains. Examples of training tasks include Emotion word brainstorming, Backwards digit span Ray verbal learning Test, and go/ no go task. Assessments will be completed at the baseline (week 1 of the intervention), halfway through the intervention (week 4) and at the conclusion of the intervention. These assessments will occur online through Zoom and be 1 hour in duration. In the assessments participants we will be asked a series of questions and complete measures that are designed to monitor/measure participants mood, depressive symptoms, anxiety, and functioning. Participants have the option of commencing an antidepressant (Vortioxetine), continuing with an already prescribed antidepressant or continuing not to take an antidepressant. Vortioxetine is recommended for use in adults with recommended doses for adults under 65 years of age being 10mg, taken orally once a day. For adults 65 years and older, a starting dose of 5mg once daily is recommended. These doses may be increased to 20mg per day or decreased to 5mg per day at the discretion of the psychiatrist. The administration of Vortioxetine will be monitored by one of the psychiatrists working on the study. All participants will have telehealth visits with one of the study psychiatrists for the duration of their involvement in the study. These mental health reviews with the psychiatrist will occur at the same time points during the study regardless of whether the participant elects to take Vortioxetine. The mental health reviews will occur in week 0 (before the participant commences Vortioxetine if applicable) prior to commencing the intervention, in week 3, week 5 and week 7 of the intervention, and week 9 following completion of the intervention. For participants who elect to commence Vortioxetine, blood tests will also be used to monitor participants sodium levels. Therefore the timing of these blood tests will be before the participant begins taking Vortioxetine (week 0) and then again two weeks after the participant firsts starts the medication. Additional blood tests will be administered if the participants dosage of Vortioxetine is increased by the psychiatrist. Participants can complete the blood tests at their local pathology centre or at Royal Melbourne Hospital pathology centre. Adherence to medication will be monitored through participants completing a medication diary and discussions with the psychiatrist during the mental health reviews. Vortioxetine administration will occur over the course of intervention (8 weeks). It takes 2-6 weeks to see the potential benefits of the Vortioxetine in the participant. As an extension phase of this study, a 6-month supply of the medication will be available to participants (free of charge) once the study has ended. The 6-month supply of Vortioxetine will be available to participants who commence Vortioxetine as part of their involvement in the study or who were taking Vortioxetine prior to study commencement and elect to continue this same antidepressant during the study. The 6-month supply of Vortioxetine will be dispensed in an initial 3 month supply with a further 3 month supply accessible following a review of the participant by their General Practitioner. After this point, the participant will have the choice to continue the Vortioxetine, incurring the full cost of the medication, or switch to another anti-depressant that is supplied under the pharmaceutical benefits scheme.