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      Smartphone-based ecological momentary assessment and intervention in a coping-focused intervention for hearing voices (SAVVy): study protocol for a pilot randomised controlled trial

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          Abstract

          Background

          Smartphone-based ecological momentary assessment and intervention (EMA/I) show promise for enhancing psychological treatments for psychosis. EMA has the potential to improve assessment and formulation of experiences which fluctuate day-to-day, and EMI may be used to prompt use of therapeutic strategies in daily life. The current study is an examination of these capabilities in the context of a brief, coping-focused intervention for distressing voice hearing experiences.

          Methods/design

          This is a rater-blinded, pilot randomised controlled trial comparing a four-session intervention in conjunction with use of smartphone EMA/I between sessions, versus treatment-as-usual. The recruitment target is 34 participants with persisting and distressing voice hearing experiences, recruited through a Voices Clinic based in Melbourne, Australia, and via wider advertising. Allocation will be made using minimisation procedure, balancing of the frequency of voices between groups. Assessments are completed at baseline and 8 weeks post-baseline. The primary outcomes of this trial will focus on feasibility and acceptability of the intervention and trial methodology, with secondary outcomes examining preliminary clinical effects related to overall voice severity, the emotional and functional impact of the voices, and emotional distress.

          Discussion

          This study offers a highly novel examination of specific smartphone capabilities and their integration with traditional psychological treatment for distressing voices. Such technology has potential to enhance psychological interventions and promote adaptation to distressing experiences.

          Trial registration

          Australian New Zealand Clinical Trial Registry, ACTRN12617000348358. Registered on 7 March 2017.

          Electronic supplementary material

          The online version of this article (10.1186/s13063-018-2607-6) contains supplementary material, which is available to authorized users.

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          Most cited references36

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          Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study

          Background External pilot or feasibility studies can be used to estimate key unknown parameters to inform the design of the definitive randomised controlled trial (RCT). However, there is little consensus on how large pilot studies need to be, and some suggest inflating estimates to adjust for the lack of precision when planning the definitive RCT. Methods We use a simulation approach to illustrate the sampling distribution of the standard deviation for continuous outcomes and the event rate for binary outcomes. We present the impact of increasing the pilot sample size on the precision and bias of these estimates, and predicted power under three realistic scenarios. We also illustrate the consequences of using a confidence interval argument to inflate estimates so the required power is achieved with a pre-specified level of confidence. We limit our attention to external pilot and feasibility studies prior to a two-parallel-balanced-group superiority RCT. Results For normally distributed outcomes, the relative gain in precision of the pooled standard deviation (SD p ) is less than 10% (for each five subjects added per group) once the total sample size is 70. For true proportions between 0.1 and 0.5, we find the gain in precision for each five subjects added to the pilot sample is less than 5% once the sample size is 60. Adjusting the required sample sizes for the imprecision in the pilot study estimates can result in excessively large definitive RCTs and also requires a pilot sample size of 60 to 90 for the true effect sizes considered here. Conclusions We recommend that an external pilot study has at least 70 measured subjects (35 per group) when estimating the SD p for a continuous outcome. If the event rate in an intervention group needs to be estimated by the pilot then a total of 60 to 100 subjects is required. Hence if the primary outcome is binary a total of at least 120 subjects (60 in each group) may be required in the pilot trial. It is very much more efficient to use a larger pilot study, than to guard against the lack of precision by using inflated estimates.
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            Memory impairment in schizophrenia: a meta-analysis.

            Memory impairment is well documented in schizophrenia. Less is known, however, about the exact magnitude, pattern, and extent of the impairment. The effect of potential moderator variables, such as medication status and duration of illness, is also unclear. In this article, the authors presented meta-analyses of the published literature on recall and recognition memory performance between patients with schizophrenia and normal comparison subjects. Meta-analyses were conducted on 70 studies that reported measures of long-term memory (free recall, cued recall, and recognition of verbal and nonverbal material) and short-term memory (digit span). Tests of categorical models were used in analyses of potential moderators (clinical variables and study characteristics). The findings revealed a significant and stable association between schizophrenia and memory impairment. The composite effect size for recall performance was large. Recognition showed less, but still significant, impairment. The magnitude of memory impairment was not affected by age, medication, duration of illness, patient status, severity of psychopathology, or positive symptoms. Negative symptoms showed a small but significant relation with memory impairment. This meta-analysis documented significant memory impairment in schizophrenia. The impairment was stable, wide ranging, and not substantially affected by potential moderating factors such as severity of psychopathology and duration of illness.
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              Using experience sampling methods/ecological momentary assessment (ESM/EMA) in clinical assessment and clinical research: introduction to the special section.

              This article introduces the special section on experience sampling methods and ecological momentary assessment in clinical assessment. We review the conceptual basis for experience sampling methods (ESM; Csikszentmihalyi & Larson, 1987) and ecological momentary assessment (EMA; Stone & Shiffman, 1994). Next, we highlight several advantageous features of ESM/EMA as applied to psychological assessment and clinical research. We provide a brief overview of the articles in this special section, each of which focuses on 1 of the following major classes of psychological disorders: mood disorders and mood dysregulation (Ebner-Priemer & Trull, 2009), anxiety disorders (Alpers, 2009), substance use disorders (Shiffman, 2009), and psychosis (Oorschot, Kwapil, Delespaul, & Myin-Germeys, 2009). Finally, we discuss prospects, future challenges, and limitations of ESM/EMA.
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                Author and article information

                Contributors
                ibell@swin.edu.au
                s.fielding-smith@sussex.ac.uk
                mark.hayward@sussexpartnership.nhs.uk
                srossell@swin.edu.au
                mlim@swin.edu.au
                j.farhall@latrobe.edu.au
                neilthomas@swin.edu.au
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                2 May 2018
                2 May 2018
                2018
                : 19
                : 262
                Affiliations
                [1 ]ISNI 0000 0004 0409 2862, GRID grid.1027.4, Centre for Mental Health, , Swinburne University of Technology, ; Hawthorn, Australia
                [2 ]ISNI 0000 0004 0623 9709, GRID grid.476960.a, Monash Alfred Psychiatry Research Centre, ; Melbourne, Australia
                [3 ]ISNI 0000 0004 0489 3918, GRID grid.451317.5, Sussex Partnership NHS Foundation Trust, ; Worthing, UK
                [4 ]ISNI 0000 0004 1936 7590, GRID grid.12082.39, School of Psychology, , University of Sussex, ; Brighton, UK
                [5 ]ISNI 0000 0000 8606 2560, GRID grid.413105.2, Department of Psychiatry, , St. Vincent’s Hospital, ; Melbourne, Australia
                [6 ]ISNI 0000 0001 2342 0938, GRID grid.1018.8, Department of Psychology and Counselling, , La Trobe University, ; Melbourne, Australia
                [7 ]ISNI 0000 0004 0452 651X, GRID grid.429299.d, NorthWestern Mental Health, , Melbourne Health, ; Melbourne, Australia
                Article
                2607
                10.1186/s13063-018-2607-6
                5930938
                29720208
                fab79877-bd87-4657-8172-e55ba1b34c0e
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 18 January 2018
                : 13 March 2018
                Funding
                Funded by: Barbara Dicker Foundation (BDF) Research Support Scheme
                Award ID: NA
                Award Recipient :
                Funded by: Australian Government Research Training Program Scholarship
                Award ID: NA
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2018

                Medicine
                digital technology,smartphone app,ecological momentary assessment,ecological momentary intervention,psychosis,hearing voices,auditory hallucinations,randomised controlled trial

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