Cognitive and emotional recovery training for depression (CERT-D).

• Register: ANZCTR
• Last refreshed on: 20 August 2018
• Main ID: ACTRN12617000899347
• Date of registration: 19/06/2017
• Prospective Registration: Yes
• Primary sponsor: Prof Bernhard Baune
• Public title: Cognitive and emotional recovery training for depression (CERT-D).
• Scientific title: Efficacy of Cognitive and emotional recovery training for depression (CERT-D).
• Date of first enrolment: 1/09/2017
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://www.anzctr.org.au/ACTRN12617000899347.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel

Health Condition(s) or Problem(s) studied

Depression

Intervention(s)

All components of the intervention will take place at the clinical research facility (CRF) in the Adelaide Health and Medical Sciences building, North Terrace, Adelaide, South Australia. The intervention program will occur over 8 weeks, with 2x1hour intervention sessions per week (16hrs total). The intervention will involve training tasks targeting cognitive, emotional and social cognitive ability. Half of the participants will complete a personalised treatment, while the other half complete a standard (i.e., non-personalised) treatment. Personalised treatments will be tailored around individuals' baseline deficits, with more treatment sessions devoted to dysfunctional domains. Baseline performance will be evaluated with tests of cognition (i.e., the THINC-it tool), emotion (i.e., the PANAS) and social cognitive (i.e., the WAIS-IV-ACS-SCT), which will indicate which domains are significantly impaired (i.e., .5 SDs below the norm). In contrast, standard treatment will be the same regardless of observed baseline deficits.

Each treatment session will be devoted to a particular domain (i.e., cognition, emotion, social cognition). Cognition sessions will focus on "cold" cognitive tasks (e.g., Card sorting, Tower of London, Mental rotation). Emotion sessions will involve emotion processing and memory tasks (e.g., emotional word list memory, memory for facial affect). Social cognition sessions will involve discrimination of social cues and theory of mind tasks (e.g., "reading the mind in the eyes", Happe's Strange stories). Treatment sessions will be administered to participants individually and face to face with the researcher. Some tasks will be completed with pen and paper, while others will be completed on a computer.

The intervention will be delivered by Mr Matthew Knight. Mr Knight has submitted a PhD in experimental cognitive psychology and has experience testing, recording and analysing cognitive performance. Mr Knight will be supervised by Prof Bernhard Baune who has extensive clinical and research experience in mood disorders and cognitive dysfunction disorders obtained over many years. Prof Baune has expertise with clinical interviews, neuropsychological assessments, specimen collection and self-report questionnaires. Prior to involvement in the intervention Mr knight will undergo additional training in these
areas.

At 4 weeks (mid-RCT) subjects' performance will be assessed. Participants will be withdrawn from treatment if depression symptom severity has worsened significantly relative to baseline (i.e., greater than or equal to 20% increase in MADRS score). If this occurs, withdrawn subjects will be referred to their treating psychiatrist or GP.

Treatment adherence will be monitored by recording whether participants attend the required sessions (2 per week), and whether participants complete the entire 8 week intervention.