Administrative information
Title {1} | A randomised controlled trial to investigate the clinical effectiveness and cost-effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for depressed non-responders to Increasing Access to Psychological Therapies (IAPT) high-intensity therapies |
Trial registration {2a and 2b}. | ClinicalTrials.gov: NCT05236959, 11.02.2022 ISRCTN 17755571, 02.02.2021 |
Protocol version {3} | Version 3.0 [28.10.2022] |
Funding {4} | This trial is funded through the Research for Patient Benefit (RfPB) Programme of the National Institute for Health Research (NIHR). The funders number for this trial is NIHR200750. |
Author details {5a} | Thorsten Barnhofer, University of Surrey, School of Psychology, Guildford, UK GU2 7XH, phone: 01,483 686,485, email: t.barnhofer@surrey.ac.uk Barney Dunn, University of Exeter, Department of Psychology, Washington Singer Laboratories, University of Exeter, Perry Road, Prince of Wales Road, Exeter, EX4 4QG, email: b.d.dunn@exeter.ac.uk Clara Strauss, University of Sussex, Sussex House, Falmer, Brighton, BN1 9RH, United Kingdom, email:c.y.strauss@sussex.ac.uk Florian Ruths, South London and Maudsley NHS Foundation Trust, IPTT Southwark, Maudsley Hospital Outpatient Building, 105 Denmark Hill, London SE5 8AZ, email: florian.ruths@slam.nhs.uk Barbara Barrett, King’s College London, King’s Health Economics, Box P024, Institute of Psychiatry, Psychology & Neuroscience, De Crespigny Park, London, SE5 8AF, email: barbara.m.barrett@kcl.ac.uk Mary Ryan, Department of Health and Social Care Innovation, London South Bank University, 103 Borough Road, SE1 0AA, email: mary@highbag.co.uk Asha Ladwa, Devon Partnership Trust, Wonford House, Dryden Road, Exeter, EX2 5AF, email: asha.ladwa@nhs.net Frances Stafford, Sussex Partnership NHS Foundation Trust, Hove, BN3 7HY, email: frances.stafford@spft.nhs.uk Roberta Fichera, South London and Maudsley NHS Foundation Trust, IPTT Southwark, Maudsley Hospital Outpatient Building, 105 Denmark Hill, London SE5 8AZ, email: roberta.fichera@slam.nhs.uk Hannah Baber, Devon Partnership Trust, Wonford House, Dryden Road, Exeter, EX2 5AF, email: hannah.baber@nhs.net Ailis McGuinness, University of Exeter, Department of Psychology, Washington Singer Laboratories, University of Exeter, Perry Road, Prince of Wales Road, Exeter, EX4 4QG, email: a.mcguinness@exeter.ac.uk Isabella Metcalfe, South London and Maudsley NHS Foundation Trust, IPTT Southwark, Maudsley Hospital Outpatient Building, 105 Denmark Hill, London SE5 8AZ, email: isabella.metcalfe@slam.nhs.uk Delilah Harding, South London and Maudsley NHS Foundation Trust, IPTT Southwark, Maudsley Hospital Outpatient Building, 105 Denmark Hill, London SE5 8AZ, email: delilah.harding@nihr.ac.uk Sarah Walker, University of Exeter, College of Medicine and Health, Smeal Building, St Luke’s Campus, Heavitree Road, Exeter, EX1 2LU, email: s.walker@exeter.ac.uk Poushali Ganguli, King’s College London, King’s Health Economics, Box P024, Institute of Psychiatry, Psychology & Neuroscience, De Crespigny Park, London, SE5 8AF, email: poushali.ganguli@kcl.ac.uk Dr Shelley Rhodes, University of Exeter, College of Medicine and Health, College House, St Luke’s Campus, Heavitree Road, Exeter, EX1 2LU, email: s.rhodes@exeter.ac.uk Prof Allan Young, King’s College London, Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, PO72 De Crespigny Park, London SE5 8AF, United Kingdom, phone: 020 78,480,086, email: allan.young@kcl.ac.uk Dr Fiona Warren, University of Exeter, College of Medicine and Health, Smeal Building, St Luke’s Campus, Heavitree Road, Exeter, EX1 2LU, phone: 01,392 722,749, email: f.c.warren@exeter.ac.uk |
Name and contact information for the trial sponsor {5b} | Sussex Partnership NHS Foundation Trust, Ms Taffy Bakasa, Lead Governance Officer, R & D Department, Sussex Education Centre, Nevill Avenue, Hove, BN3 7HY, Tel: 0300 3,040,088, Email: taffy.bakasa@sussexpartnership.nhs.uk |
Role of sponsor {5c} | The trial sponsor has ultimate authority over the management of the study. Neither the funder nor the sponsor of the trial was involved in the design of the study and will not be involved in the collection, analysis or interpretation of data or the writing of the study report. The funder will be required to approve the final report prior to publication. |
Introduction
Background and rationale {6a}
Objectives {7}
Aims
Objectives
Hypotheses
Trial design {8}
Methods: participants, interventions and outcomes
Study setting {9}
Eligibility criteria {10}
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Primary outcome
Secondary outcomes
Baseline survey
Economic evaluation
Qualitative analyses
Participant timeline {13}
Sample size {14}
Recruitment {15}
Assignment of interventions: allocation
Sequence generation {16a}
Concealment mechanism {16b}
Implementation {16c}
Assignment of interventions: blinding
Who will be blinded {17a}
Procedure for unblinding if needed {17b}
Data collection and management
Plans for assessment and collection of outcomes {18a}
Plans to promote participant retention and complete follow-up {18b}
Data management {19}
Confidentiality {27}
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
Statistical methods
Statistical methods for primary and secondary outcomes {20a}
Interim analyses {21b}
Methods for additional analyses (e.g. subgroup analyses) {20b}
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
Plans to give access to the full protocol, participant-level data and statistical code {31c}
Oversight and monitoring
Composition of the coordinating centre and trial steering committee {5d}
Composition of the data monitoring committee, its role and reporting structure {21a}
Adverse event reporting and harms {22}
Risk monitoring
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A participant’s score has increased by 6 points or more from baseline assessment, specifying the amount of increase, and/or
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A participant scores 1 or more on item 9 of PHQ-9, specifying what the score is and whether this score is typical or represents a change
Adverse event and serious adverse event recording and reporting
-
Results in death
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Is life-threatening (where the term life-threatening refers to an event in which the patient is at risk of death at the time of the event; it does not refer to an event that might hypothetically cause death if it was more severe (e.g. a silent myocardial infarction))
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Requires inpatient hospitalisation or prolongation of existing hospitalisation
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Results in persistent or significant disability or incapacity
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Consists of a congenital anomaly or birth defect
-
Or any other health event which in the opinion of the clinician is serious
Relationship | Description | Event type |
---|---|---|
Unrelated | There is no evidence of any causal relationship | Unrelated SAE |
Unlikely to be related | There is little evidence to suggest that there is a causal relationship (e.g. the event did not occur within a reasonable time after administration of the trial treatment). There is another reasonable explanation for the event (e.g. the participant’s clinical condition or other concomitant treatment) | Unrelated SAE |
Possibly related | There is some evidence to suggest a causal relationship (e.g. because the event occurs within a reasonable time after administration of the trial treatment). However, the influence of other factors may have contributed to the event (e.g. the participant’s clinical condition or other concomitant treatment) | SAR |
Probably related | There is evidence to suggest a causal relationship and the influence of other factors is unlikely | SAR |
Definitely related | There is clear evidence to suggest a causal relationship and other possible contributing factors can be ruled out | SAR |