None listed
Conditions
Brief summary
The primary purpose of this study is to evaluate the clinical efficacy of a treatment designed to improve psychosocial function in depressed individuals. The proposed study assumes that cognitive, emotional and social cognitive impairments underlie (i.e., cause) psychosocial dysfunction. Accordingly, the proposed study will target functioning in these domains by administering repeated cognitive, emotional and social cognitive treatment tasks. Overall, the study consists of an 8 week RCT and an observational 6 months post-RCT follow-up phase. As primary outcome, we expect that psychosocial function (as measured by the FAST) will be improved at 8 weeks (end of RCT) relative to baseline, and that this improvement will be retained over a 6 month observational period. In addition, the effect of treatment on resilience, occupational functioning, functional disability, cognitive failures and depression symptom severity will also be measured. Also of interest is whether serum biomarkers related to cognition and psychosocial function are sensitive to treatment, as there is little research in this area. It is possible that personalising treatment by individuals’ baseline impairments will lead to more effective treatment outcomes. To this end, half of the participants will complete a personalised treatment while the other half complete a standard (i.e., non-personalised treatment). Although we expect that the personalised treatment arm will result in greater improvement than the standard treatment arm, we expect clinical improvements of patients in both treatment arms during the RCT phase.
Interventions
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.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Participants have current or remitted MDD, as confirmed by the MINI Neuropsychiatric Diagnostic Interview. 2. Depression symptom severity in current MDD participants demonstrated as clinically significant (greater than or equal to 15) according to the Structured Interview Guide of the Hamilton Anxiety and Depression Scale (SIGH-AD). 3. Depression symptom severity demonstrated as mild (7-12), mild-moderate (13-19), or moderate (20-30) according the Montgomery Asberg Depression Rating Scale (MADRS) (Svanborg & Asberg, 2001). 4. Participants must be between 18 and 80 years of age. 5. Participants must be willing and able to complete digital treatment tasks presented on a computer.
Exclusion criteria
1. Current alcohol and / or substance use disorder. 2. Current diagnosis of Bipolar or Anxiety disorder. 3. Depression symptom severity demonstrated as severe (31+) according the Montgomery Asberg Depression Rating Scale (MADRS). 4. Previous diagnosis of or identified through screening with schizophrenia, a learning disorder, eating disorder, or a Pervasive Developmental Disorder (e.g., autism spectrum disorder). 5. Brain injury or impairment which could affect cognitive function (e.g., neurodevelopmental disorders, dementia) 6. Participants will be withdrawn from the study if they have subsequent severe brain/head injury; develop dementia; develop psychosis; or develop neurological conditions such as Multiple Sclerosis or Parkinson’s Disease. 7. Unable to complete questionnaires in written English