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Background: e-Health tools using validated questionnaires to assess outcomes may facilitate measurement-based care for psychiatric disorders. MoodFX was created as a free online symptom tracker to support patients for outcome measurement in their depression treatment. We conducted a pilot randomized evaluation to examine its usability, and clinical utility., Methods: Patients presenting with a major depressive episode (within a major depressive or bipolar disorder) were randomly assigned to receive either MoodFX or a health information website as the intervention and control condition, respectively, with follow-up assessment surveys conducted online at baseline, 8 weeks and 6 months. The primary usability outcomes included the percentage of patients with self-reported use of MoodFX 3 or more times during follow up (indicating minimally adequate usage) and usability measures based on the System Usability Scale (SUS). Secondary clinical outcomes included the Quick Inventory of Depressive Symptomatology, Self-Rated (QIDS-SR) and Patient Health Questionnaire (PHQ-9)., Results: Forty-nine participants were randomized (24 to MoodFX and 25 to the control condition). Of the 23 participants randomized to MoodFX who completed the user survey, 18 (78%) used MoodFX 3 or more times over the 6 months of the study. The mean SUS score of 72.7 (65th-69th percentile) represents good usability. Compared to the control group, the MoodFX group had significantly better improvement on QIDS-SR and PHQ-9 scores, with large effect sizes and higher response rates at 6 months. There were no differences between conditions on other secondary outcomes such as functioning and quality of life., Conclusion: MoodFX demonstrated good usability and was associated with reduction in depressive symptoms. This pilot study supports the use of digital tools in depression treatment., Competing Interests: Declaration of Conflicting InterestsRWL has received honoraria for ad hoc speaking or advising/consulting, or received research funds, from: Abbvie, Asia-Pacific Economic Cooperation, Bausch, BC Leading Edge Foundation, Brain Canada, Canadian Institutes of Health Research, Canadian Network for Mood and Anxiety Treatments, CB Solutions, Carnot, Genome BC, Grand Challenges Canada, Healthy Minds Canada, Janssen, Lundbeck, Michael Smith Foundation for Health Research, MITACS, Neurotorium, Ontario Brain Institute, Otsuka, Pfizer/Viatris, Shanghai Mental Health Center, Unity Health, Vancouver Coastal Health Research Institute, and VGH-UBCH Foundation. AD was partly supported by an unrestricted fellowship grant from Janssen Canada and has received honoraria for ad hoc speaking or advising/consulting, or received research funds, from: AbbVie, Canadian Institutes of Health Research and Otsuka. JJN was partially supported by a Marshall/Institute of Mental Health Fellowship Award and received unrestricted research funding from the BC Cancer Foundation, with funds originating from Pfizer. KK is supported as a health professional investigator by Michael Smith Health Research Foundation of BC, Vancouver Coastal Health Research Institute and VGH & UBC Hospital Foundation and has previously served on the scientific advisory board of AbbVie. EEM has received support for patient education activities from Otsuka-Lundbeck. LNY has received honoraria for ad hoc speaking or advising/consulting, or received research funds, from: AbbVie, Alkermes, Allergan, Canadian Institutes of Health Research, Canadian Network for Mood and Anxiety Treatments, Dainippon Sumitomo Pharma, GlaxoSmithKline, Intracellular Therapies, Lundbeck, Merck, Otsuka, Sanofi, and Sunovion. VWL, VCE, JS, DKD, DDG, AA, EMT and JKM have no disclosures.

Objective: It has been proposed that different stages of the bipolar disorder might have distinct neurobiological changes. However, the evidence for this has not been consistent, as the studies in early stages of the illness are limited by small sample sizes. The purpose of this study was to investigate the gray matter volume changes in bipolar patients who recently recovered from their first episode of mania (FEM)., Methods: Using a whole-brain voxel-based analysis, we compared the regional gray matter volumes of 61 bipolar patients who have recovered from their FEM in the past 3 months with 43 age- and gender-matched healthy participants. We also performed a series of subgroup analyses to determine the effects of hospitalization during the FEM, history of depressive episodes, and exposure to lithium., Results: No statistically significant difference was found between gray matter volumes of FEM patients and healthy participants, even at a more liberal threshold ( P < 0.001, uncorrected for multiple comparisons). Voxel-based subgroup analyses did not reveal significant gray matter differences except for a trend toward decreased gray matter volume in left lateral occipital cortex ( P < 0.001, uncorrected) in patients with a previous history of depression., Conclusion: This study represents the largest structural neuroimaging investigation of FEM published to date. Early stage of bipolar disorder was not found to be associated with significant gray matter volume changes. Our findings suggest that there might be a window of opportunity for early intervention strategies to prevent or delay neuroprogression in bipolar disorder.