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The HARMONIC trial: study protocol for a randomised controlled feasibility trial of Shaping Healthy Minds—a modular transdiagnostic intervention for mood, stressor-related and anxiety disorders in adults
  1. Melissa Black1,2,
  2. Caitlin Hitchcock1,2,
  3. Anna Bevan1,
  4. Cliodhna O Leary1,2,
  5. James Clarke2,
  6. Rachel Elliott1,2,
  7. Peter Watson1,
  8. Louise LaFortune3,
  9. Sarah Rae2,
  10. Simon Gilbody4,
  11. Willem Kuyken5,
  12. David Johnston1,2,
  13. Jill M Newby6,
  14. Tim Dalgleish1,2
  1. 1 Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, UK
  2. 2 Cambridgeshire and Peterborough NHS Foundation Trust, National Health Service, Fulbourn, UK
  3. 3 Cambridge Institute of Public Health, University of Cambridge, Cambridge, UK
  4. 4 Department of Health Sciences, University of York, York, UK
  5. 5 Department of Psychiatry, University of Oxford, Oxford, UK
  6. 6 School of Psychology, University of New South Wales, Sydney, New South Wales, Australia
  1. Correspondence to Professor Tim Dalgleish; Tim.Dalgleish{at}mrc-cbu.cam.ac.uk

Abstract

Introduction Anxiety, mood and trauma-related disorders are common, affecting up to 20% of adults. Many of these individuals will experience symptoms of more than one disorder as diagnostically defined. However, most psychological treatments focus on individual disorders and are less effective for those who experience comorbid disorders. The Healthy and Resilient Mind Programme: Building Blocks for Mental Wellbeing (HARMONIC) trial introduces a novel transdiagnostic intervention (Shaping Healthy Minds (SHM)), which synthesises several evidence-based treatment techniques to address the gap in effective interventions for people with complex and comorbid difficulties. This early phase trial aims to estimate the efficacy and feasibility of the transdiagnostic intervention in preparation for a later-phase randomised controlled trial, and to explore mechanisms of change.

Methods/analysis We outline a patient-level two-arm randomised controlled trial (HARMONIC) that compares SHM to treatment-as-usual for individuals aged >18 years (n=50) with comorbid mood, anxiety, obsessive-compulsive or trauma/stressor disorders diagnoses, recruited from outpatient psychological services within the UK National Health Service (NHS). The co-primary outcomes will be 3-month follow-up scores on self-report measures of depressive symptoms, anxiety symptoms, and disability and functional impairment. Secondary outcomes include changes in symptoms linked to individual disorders. We will assess the feasibility and acceptability of SHM, the utility of proposed outcome measures, and refine the treatment manuals in preparation for a later-phase trial.

Ethics and dissemination This trial protocol has been approved by the Health Research Authority of the NHS of the UK (East of England, Reference: 16/EE/0095). We anticipate that trial findings will inform future revisions of clinical guidelines for numerous forms of mood, anxiety and stressor-related disorders. Findings will be disseminated broadly via peer-reviewed empirical journal articles, conference presentations, clinical workshops and a trial website.

Trial registration NCT03143634; Pre-results.

  • transdiagnostic
  • depression
  • anxiety
  • posttraumatic stress disorder
  • common mental health problems

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Footnotes

  • Contributors MB will manage the trial, deliver the intervention, co-develop the treatment manuals and has helped draft the manuscript; CH will assist with trial management and has helped draft the manuscript; AB advises on the delivery of the interventions and has provided guidance on the protocol; JC provides practical and NHS service support for the trial; COL, RE and DJ provide support for the trial management; PW is the trial statistician responsible for the randomisation, advice on analysis strategy, and analysis of the data; LL provides support for the health economics component; SR provides service user support for the trial; SG and WK have advised on the treatment manual; JMN co-developed and adapted the treatment manuals; TD designed the study, co-developed and adapted the treatment manuals, and helped to draft the manuscript. All authors have read and approved the final manuscript.

  • Funding This paper presents independent research funded by the National Institute of Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0214-33072) grant awarded to TD, PW, JMN, Leonora Brosan, Rajini Ramana, LL, SR, SG, WK and CH. JMN is supported by an NHMRC/MRFF Fellowship (1145382). Please note that the funding body does not have authority over the running of the trial and all decisions rest with the trial team. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. Sponsor information: University of Cambridge School of Clinical Medicine ,Carolyn Read (Research Governance Officer).

  • Competing interests None declared.

  • Patient consent Not required.

  • Ethics approval NHS National Research Ethics Committee (East of England, Reference: 16/EE/0095).

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

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