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      The Scania Accelerated Intermittent Theta-burst Implementation Study (SATIS)–Lessons from an accelerated treatment protocol

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          Abstract

          Background and objective

          The Scania Accelerated Intermittent Theta-burst Implementation Study (SATIS) aimed to investigate the tolerability, preliminary effectiveness, and practical feasibility of an accelerated intermittent theta burst stimulation (aTBS) protocol in treating depression.

          Methods

          We used an open-label observational design, recruiting 20 patients (aged 19–84 years) from two public brain stimulation centers in Sweden. During the five-day treatment period and at a follow-up visit after 30 days we closely monitored adverse events and collected self-rated side effect data. Objective (MADRS, CGI) and subjective (MADRS-S) measures of symptoms and functioning (EQ-5D) were also assessed. Feasibility was evaluated using direct patient ratings combined with a qualitative approach evaluating staff experience.

          Results

          All patients reported adverse events at some point, the most common being headache (18/20 patients), but they were generally transient. MADRS scores decreased from 28.4 (min = 17, max = 38. SD = 6.9) at baseline to 20.0 (min = 1, max = 42. SD = 11.6) after the last day of treatment. 25% (n = 5) met the response criteria, with a mean time to response of 2.2 days (min = 1, max = 3. SD = 1.1). The practical arrangements surrounding this new treatment proved challenging for the organization, but patients reported few practical problems.

          Conclusion

          SATIS provided further insights into the potential benefits and challenges associated with aTBS protocols. Effectiveness and drop-out rates were comparable to national data of conventional iTBS, but with a markedly faster time to response. More resources were required than anticipated, increasing the clinical workload.

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          Most cited references29

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          Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness.

          Qualitative content analysis as described in published literature shows conflicting opinions and unsolved issues regarding meaning and use of concepts, procedures and interpretation. This paper provides an overview of important concepts (manifest and latent content, unit of analysis, meaning unit, condensation, abstraction, content area, code, category and theme) related to qualitative content analysis; illustrates the use of concepts related to the research procedure; and proposes measures to achieve trustworthiness (credibility, dependability and transferability) throughout the steps of the research procedure. Interpretation in qualitative content analysis is discussed in light of Watzlawick et al.'s [Pragmatics of Human Communication. A Study of Interactional Patterns, Pathologies and Paradoxes. W.W. Norton & Company, New York, London] theory of communication.
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            Is Open Access

            A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance

            The UK Medical Research Council’s widely used guidance for developing and evaluating complex interventions has been replaced by a new framework, commissioned jointly by the Medical Research Council and the National Institute for Health Research, which takes account of recent developments in theory and methods and the need to maximise the efficiency, use, and impact of research.
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              A new depression scale designed to be sensitive to change

              The construction of a depression rating scale designed to be particularly sensitive to treatment effects is described. Ratings of 54 English and 52 Swedish patients on a 65 item comprehensive psychopathology scale were used to identify the 17 most commonly occurring symptoms in primary depressive illness in the combined sample. Ratings on these 17 items for 64 patients participating in studies of four different antidepressant drugs were used to create a depression scale consisting of the 10 items which showed the largest changes with treatment and the highest correlation to overall change. The inner-rater reliability of the new depression scale was high. Scores on the scale correlated significantly with scores on a standard rating scale for depression, the Hamilton Rating Scale (HRS), indicating its validity as a general severity estimate. Its capacity to differentiate between responders and non-responders to antidepressant treatment was better than the HRS, indicating greater sensitivity to change. The practical and ethical implications in terms of smaller sample sizes in clinical trials are discussed.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Writing – original draft
                Role: ConceptualizationRole: Formal analysisRole: InvestigationRole: MethodologyRole: Writing – original draft
                Role: ConceptualizationRole: InvestigationRole: Methodology
                Role: SupervisionRole: Writing – review & editing
                Role: InvestigationRole: MethodologyRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: MethodologyRole: ResourcesRole: SupervisionRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS One
                plos
                PLOS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                2 January 2025
                2025
                : 20
                : 1
                : e0316339
                Affiliations
                [1 ] University Psychiatric Department, Helsingborg, Sweden
                [2 ] Department of Adult Psychiatry, Malmö, Sweden
                [3 ] Hadsibrandt AB, Helsingborg, Sweden
                [4 ] Department of Health Sciences/Mental Health, Activity and Participation, Lund University, Lund, Sweden
                [5 ] HMNC Brain Health, Munich, Germany
                [6 ] Department of Clinical Sciences, Faculty of Medicine, Lund University, Lund, Sweden
                Taipei Veterans General Hospital, TAIWAN
                Author notes

                Competing Interests: The authors, Marcus Persson, Viktor Fabri, Alexander Reijbrandt, Annika Lexén, and Pouya Movahed Rad, have no competing interests to declare. Hans Eriksson is currently a full-time employee at HMNC Brain Health, a pharmaceutical company developing treatments for depression. This does not alter our adherence to PLOS ONE policies on data and material sharing.

                Author information
                https://orcid.org/0000-0002-4159-9019
                https://orcid.org/0000-0003-2041-3550
                Article
                PONE-D-24-25365
                10.1371/journal.pone.0316339
                11694994
                39746089
                026c1078-fbe8-45cd-936b-e285b048dc18
                © 2025 Persson et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 2 August 2024
                : 12 October 2024
                Page count
                Figures: 3, Tables: 4, Pages: 17
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/501100009802, Stiftelsen Söderström Königska Sjukhemmet;
                Award ID: SLS-570781
                Award Recipient :
                Funded by: Stig och Ragna Gorthons stiftelse
                Award ID: 2023-2963
                Award Recipient :
                Data was collected as a clinical project at the University Psychiatric Department in Helsingborg - a part of Region Skåne. Costs for APC and ethical review were covered by grants from the private foundation "Stiftelsen Söderström-Königska sjukhemmet" (grant-number SLS-570781) (PM-R). The private foundation “Stig och Ragna Gorthons stiftelse” provided financial support for MP (grant number 2023-2963) to analyse data and write the paper. No sponsor were directly involved in any way in the conduct of the research or preparation of the article. https://www.sls.se/vetenskap/sok-anslag/stift.-soderstrom/ https://www.gorthonstiftelsen.se/.
                Categories
                Research Article
                Medicine and Health Sciences
                Mental Health and Psychiatry
                Mood Disorders
                Depression
                People and Places
                Population Groupings
                Professions
                Medical Personnel
                Nurses
                Medicine and Health Sciences
                Health Care
                Health Care Providers
                Nurses
                Research and Analysis Methods
                Bioassays and Physiological Analysis
                Electrophysiological Techniques
                Brain Electrophysiology
                Transcranial Stimulation
                Transcranial Magnetic Stimulation
                Biology and Life Sciences
                Physiology
                Electrophysiology
                Neurophysiology
                Brain Electrophysiology
                Transcranial Stimulation
                Transcranial Magnetic Stimulation
                Biology and Life Sciences
                Neuroscience
                Neurophysiology
                Brain Electrophysiology
                Transcranial Stimulation
                Transcranial Magnetic Stimulation
                Biology and Life Sciences
                Neuroscience
                Brain Mapping
                Transcranial Stimulation
                Transcranial Magnetic Stimulation
                Research and Analysis Methods
                Research Design
                Clinical Research Design
                Adverse Events
                Medicine and Health Sciences
                Pharmaceutics
                Drug Therapy
                Neurological Drug Therapy
                Antidepressant Drug Therapy
                Medicine and Health Sciences
                Clinical Medicine
                Signs and Symptoms
                Headaches
                Medicine and Health Sciences
                Mental Health and Psychiatry
                Mental Health Therapies
                Medicine and Health Sciences
                Mental Health and Psychiatry
                Custom metadata
                All relevant data are within the manuscript and its Supporting Information files.

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