Mindfulness-based cognitive therapy for non-responders to IAPT (Improving Access to Psychological Therapies) treatment
| ISRCTN | ISRCTN17755571 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17755571 |
| IRAS number | 281532 |
| ClinicalTrials.gov number | NCT05236959 |
| Secondary identifying numbers | CPMS 47796, IRAS 281532 |
- Submission date
- 21/01/2021
- Registration date
- 02/03/2021
- Last edited
- 16/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Background and study aims
If not treated sufficiently, Major Depression tends to take a recurrent or chronic lifetime course that is associated with a significantly increased risk for physical and neurodegenerative disorders. IAPT services provide evidence-based treatment for patients with common mental disorder with an access rate intended to rise to 25% of this population by 2021. However, about 50% of the depressed patients who come to the end of this pathway, have not responded sufficiently.
Our research will investigate whether Mindfulness-Based Cognitive Therapy (MBCT), a group-based treatment combining intensive training in mindfulness meditation and cognitive therapy, can effectively reduce symptoms and lead to sustained recovery in patients suffering from Major Depressive Disorder who have not sufficiently responded to high-intensity evidence-based therapy and have thus come to the end of the Increasing Access to Psychological Therapies (IAPT) care pathway. It will also test whether the introduction of this treatment can reduce subsequent service use.
Who can participate?
Adults aged18 - 65 years, who have not responded to a minimal effective dose of high-intensity treatment in IAPT (at least 12 sessions)
What does the study involve?
Patients who have not sufficiently responded to IAPT high-intensity therapy will be randomly allocated to take part either in MBCT, delivered via videoconferencing, or to continue with TAU in a three-centre (London, Exeter, Sussex) RCT.
Potential participants will be invited to one of the research sites to determine eligibility using clinical interviews and questionnaires. Eligible participants either receive an eight-week course of MBCT or continue with their treatment as usual. Follow-up assessments will be conducted remotely using online questionnaires.
What are the possible benefits and risks of participating?
Those who are randomly allocated to MBCT will have the opportunity to receive this treatment. However, to date, there is only preliminary evidence for its effectiveness in people who are currently suffering from symptoms. We do not anticipate that this research study will place participants at any more risk than they would face if attending other treatment programmes.
Where is the study run from?
University of Surrey (UK)
When is the study starting and how long is it expected to run for?
January 2021 to October 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Prof. Thorsten Barnhofer, t.barnhofer@surrey.ac.uk
Contact information
Prof Thorsten Barnhofer
Scientific
Scientific
School of Psychology
University of Surrey
Guildford
GU2 7XH
United Kingdom
 ORCID ID |
0000-0003-2984-8454 |
|---|---|
| Phone | +44(0)1483686485 |
| t.barnhofer@surrey.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | ISRCTN17755571_PIS_v01.2_21Jan21.docx |
| Scientific title | 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 |
| Study acronym | RESPOND |
| Study hypothesis | 1. Participants who receive Mindfulness-Based Cognitive Therapy (MBCT) will show significantly stronger reductions in depressive symptomatology than participants who receive TAU both at 10 weeks post-randomisation (post-treatment; secondary outcome) and at 34 weeks post-randomisation (primary outcome) 2. The MBCT intervention will be cost-effective either in terms of reductions in costs elsewhere in the health system or in improvements in outcomes |
| Ethics approval(s) | Approved 18/01/2021, West of Scotland REC 4 (Research Ethics, Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, UK; +44(0)141 314 0213; WoSREC4@ggc.scot.nhs.uk), ref: 20/WS/0177 |
| Condition | Depression |
| Intervention | Current intervention as of 03/10/2022: Design We will randomise 234 patients who have not responded to high-intensity IAPT interventions for depression, but do not meet eligibility criteria for secondary care services, in a 2-arm trial to take part in either MBCT or to continue with TAU, a comparator that is reflective of the current state of care (and in most cases will entail continued use of antidepressant medication). We will measure outcomes at baseline, 10-week and 34-week follow-up postrandomisation. Economic analyses will investigate effects of the interventions on subsequent service use. Intervention Participants will be allocated to receive either MBCT or TAU. MBCT combines mindfulness training with elements from cognitive therapy. We will follow the treatment manual with minor adaptations to address the fact that patients are suffering from current symptoms of depression following practice from our previous research (Barnhofer et al., 2009). The intervention will be delivered by trained MBCT therapists together with an assistant to groups of 13 patients using videoconferencing on a secure online platform. All three sites have prior experience with delivering MBCT in this format and will follow shared internal guidelines for videoconferencing delivery. All therapists will meet qualification in line with Good Practice Guidelines and competency level 'proficient' on the MBCT Therapy Pathway. Therapists will be selected based on ratings on the MBI-TAC and receive a one-day workshop fo familiarise them with the modifications of the program necessary for use with currently depressed patients. Manual adherence and treatment fidelity will be monitored using methods established in our previous trials (Williams et al., 2014; Barnhofer et al., 2009). MBCT consists of eight weekly group-based sessions and participants are asked to engage in home practice of mindfulness meditation for about an hour per day using guided meditation audio recordings, with attendance and practice monitored following previously established practices. Participants in the TAU condition will be asked to continue with their usual care and follow the regimes suggested by their GP or mental health professional, which in most cases will consist of continuing use of antidepressant medication. Following previous practice in our trials (Williams et al., 2014), TAU participants will be invited to an interview to prevent tendencies towards ‘resentful demoralisation' and highlight the importance of their contribution. As the pre-class interview for the MBCT courses, this interview will be conducted via videoconferencing. Following suggestions from our patient representatives, all participants will be offered access to online mindfulness resources after the end of the study. Baseline survey Participant characteristics assessed as part of the SCID interview will allow us to make comparisons between eligible patients who declined to participate, and those patients who participated in the trial. Economic evaluation The economic evaluation, led by Dr Barbara Barrett, will take a health and social care perspective, as required for evidence presented to NICE. In addition, the cost perspective will be broadened to include the costs of time off productivity losses, since these are known to be relevant and important in those attending IAPT services. Costs will be calculated by collecting service use information using the Adult Service Use Schedule (AD-SUS), as self-report measure developed by the team at King’s and used in previous trials of MBCT, modified for use online, to which routine unit costs will be applied. We will collect data on all service use not just use related to mental health conditions, because there is evidence that successful treatment in IAPT can reduce use of all healthcare services. In addition, comparison via randomised groups will ensure that any differences in cost are due to the impact of the MBCT intervention. Information on TAU will be collected via the AD-SUS, modified to ensure that all relevant services are included. Data on the use of the MBCT intervention will be collected via therapist records and costs estimated using the standard approach set out by Curtis (2008), acknowledging the challenges of costing group-based interventions. Outcomes for the economic evaluation will be QALYs, calculated using health utilities derived from the EQ-5D, either the 5L or the 3L will be used depending on the most recent advice from NICE. Costs and outcomes will be combined in a cost-utility analysis providing information on whether or not MBCT is worthwhile in terms of costs savings elsewhere or improvements in outcomes, and information will be provided to decision makers with statistical analysis of differences in costs, cost-effectiveness planes and cost effectiveness acceptability curves. Qualitative analyses Qualitative analyses, led by Prof Barney Dunn, will be used to explore patient experience of the intervention and to understand how the treatment might best benefit patients in the IAPT pathway. Previous trials have shown considerable variation in the degree to which patients engage in mindfulness practice and a major focus of the qualitative analyses will therefore be on factors influencing such engagement and its relation with dynamics of change. For this purpose, we will investigate: 1. Patients’ views on acceptability of MBCT and mindfulness practice, and the experience of participating in the course remotely 2. Patients’ views of the changes they experience and their utilization of mindfulness skills 3. Patients’ views of the broader impact of MBCT on their lives A subsample of participants in the MBCT arm, estimated to be 24 (or until data saturation has been reached), will be invited to a qualitative telephone interview conducted by trained research assistants. Recruitment will be purposive, including patients across all sites, and seeking to achieve maximum variation in relation to: 1. Completion/non-completion of treatment 2. Response/non-response to treatment 3. Recruitment site (to examine contextual factors) Written feedback provided in the protocol sheets that MBCT participants receive on a weekly basis will be used to inform subsampling and will also provide us with the opportunity to explore any unanticipated experiences and effects in more depth. In collaboration with service users, we will develop, and pilot test, a semi-structured topic guide based on the above aims. Interviews will be audio-recorded, transcribed verbatim, and anonymized. Thematic analysis of interview transcripts will be conducted using a Framework approach, involving the coding and sorting of textual units according to both deductive and inductively-derived categories, and the use of matrices to review the coded data, investigate commonalities and differences and search for patterns. Coding and data management will be facilitated by NVivo software. Randomisation We will allocate individual participants to either MBCT or TAU at a ratio of 1:1 through remote randomisation at the UKCRC-registered Exeter Clinical Trials Unit (ExeCTU), following informed consent, completion of baseline assessment and enrolment in the trial. Randomisation will use minimisation on depression severity (PHQ-9<19 versus ≥19), antidepressant use at baseline and recruitment site. Data collection methods At baseline, trained research assistants will administer clinical interviews and self-report questionnaires at each of the sites. Post-treatment and follow-up assessments will be conducted remotely by asking participants to complete self-report questionnaires on a dedicated webpage via secure online portal. Blinding As baseline assessment of participants is carried out prior to randomisation, there is no risk of disclosure of treatment allocation to the assessor at the time. Use of remote assessments, initiated through automated email, will rule out any potential effects of assessors on assessments of outcomes. The statisticians will remain blind to treatment allocation throughout the analysis. _______ Previous intervention: Design We will randomise 234 patients who have not responded to high-intensity IAPT interventions for depression, but do not meet eligibility criteria for secondary care services, in a 2-arm trial to take part in either MBCT or to continue with TAU, a comparator that is reflective of the current state of care (and in most cases will entail continued use of antidepressant medication). We will measure outcomes at baseline, 10-week and 34-week follow-up postrandomisation. Economic analyses will investigate effects of the interventions on subsequent service use. Intervention Participants will be allocated to receive either MBCT or TAU. MBCT combines mindfulness training with elements from cognitive therapy. We will follow the treatment manual with minor adaptations to address the fact that patients are suffering from current symptoms of depression following practice from our previous research (Barnhofer et al., 2009). The intervention will be delivered by trained MBCT therapists together with an assistant to groups of 13 patients using videoconferencing on a secure online platform. All three sites have prior experience with delivering MBCT in this format and will follow shared internal guidelines for videoconferencing delivery. All therapists will meet qualification in line with Good Practice Guidelines and competency level 'proficient' on the MBCT Therapy Pathway. Therapists will be selected based on ratings on the MBI-TAC and receive a one-day workshop fo familiarise them with the modifications of the program necessary for use with currently depressed patients. Manual adherence and treatment fidelity will be monitored using methods established in our previous trials (Williams et al., 2014; Barnhofer et al., 2009). MBCT consists of eight weekly group-based sessions and participants are asked to engage in home practice of mindfulness meditation for about an hour per day using guided meditation audio recordings, with attendance and practice monitored following previously established practices. Participants in the TAU condition will be asked to continue with their usual care and follow the regimes suggested by their GP or mental health professional, which in most cases will consist of continuing use of antidepressant medication. Following previous practice in our trials (Williams et al., 2014), TAU participants will be invited to an interview to prevent tendencies towards ‘resentful demoralisation' and highlight the importance of their contribution. As the pre-class interview for the MBCT courses, this interview will be conducted via videoconferencing. Following suggestions from our patient representatives, all participants will be offered access to online mindfulness resources after the end of the study. Baseline survey Participant characteristics assessed as part of the SCID interview will allow us to make comparisons between eligible patients who declined to participate, and those patients who participated in the trial. Economic evaluation The economic evaluation, led by Dr Barbara Barrett, will take a health and social care perspective, as required for evidence presented to NICE. In addition, the cost perspective will be broadened to include the costs of time off productivity losses, since these are known to be relevant and important in those attending IAPT services. Costs will be calculated by collecting service use information using the Adult Service Use Schedule (AD-SUS), as self-report measure developed by the team at King’s and used in previous trials of MBCT, modified for use online, to which routine unit costs will be applied. We will collect data on all service use not just use related to mental health conditions, because there is evidence that successful treatment in IAPT can reduce use of all healthcare services. In addition, comparison via randomised groups will ensure that any differences in cost are due to the impact of the MBCT intervention. Information on TAU will be collected via the AD-SUS, modified to ensure that all relevant services are included. Data on the use of the MBCT intervention will be collected via therapist records and costs estimated using the standard approach set out by Curtis (2008), acknowledging the challenges of costing group-based interventions. Outcomes for the economic evaluation will be QALYs, calculated using health utilities derived from the EQ-5D, either the 5L or the 3L will be used depending on the most recent advice from NICE. Costs and outcomes will be combined in a cost-utility analysis providing information on whether or not MBCT is worthwhile in terms of costs savings elsewhere or improvements in outcomes, and information will be provided to decision makers with statistical analysis of differences in costs, cost-effectiveness planes and cost effectiveness acceptability curves. Qualitative analyses Qualitative analyses, led by Prof Barney Dunn, will be used to explore patient experience of the intervention and to understand how the treatment might best benefit patients in the IAPT pathway. Previous trials have shown considerable variation in the degree to which patients engage in mindfulness practice (10)and a major focus of the qualitative analyses will therefore be on factors influencing such engagement and its relation with dynamics of change. For this purpose, we will investigate: 1) patients’ views on acceptability of MBCT and mindfulness practice, and the experience of participating in the course remotely, 2) patients’ views of the changes they experience and their utilization of mindfulness skills, and 3) patients’ views of the broader impact of MBCT on their lives. A subsample of participants in the MBCT arm, estimated to be 24 (or until data saturation has been reached), will be invited to a qualitative telephone interview conducted by trained research assistants. Recruitment will be purposive, including patients across all sites, and seeking to achieve maximum variation in relation to: 1) completion/non-completion of treatment, 2) response/non-response to treatment, and 3) recruitment site (to examine contextual factors). Written feedback provided in the protocol sheets that MBCT participants receive on a weekly basis will be used to inform subsampling and will also provide us with the opportunity to explore any unanticipated experiences and effects in more depth. In collaboration with service users, we will develop, and pilot test, a semi-structured topic guide based on the above aims. Interviews will be audio-recorded, transcribed verbatim, and anonymized. Thematic analysis of interview transcripts will be conducted using a Framework approach, involving the coding and sorting of textual units according to both deductive and inductively-derived categories, and the use of matrices to review the coded data, investigate commonalities and differences and search for patterns. Coding and data management will be facilitated by NVivo software. Timeline for delivery In each site, we will recruit 3 cohorts of 26 participants with an initial recruitment phase of 3 months and at least 1-month intervals between treatment phases. Anticipated total duration is 24 months including 3 months for set-up, 7 months for final follow-up and assessment of the last cohort, and 4 months for data analysis and write-up. Randomisation We will allocate individual participants to either MBCT or TAU at a ratio of 1:1 through remote randomisation at the UKCRC-registered Exeter Clinical Trials Unit (ExeCTU), following informed consent, completion of baseline assessment and enrolment in the trial. Randomisation will use minimisation on depression severity (PHQ-9<19 versus ≥19), antidepressant use at baseline and recruitment site. Data collection methods At baseline, trained research assistants will administer clinical interviews and self-report questionnaires at each of the sites. Post-treatment and follow-up assessments will be conducted remotely by asking participants to complete self-report questionnaires on a dedicated webpage via secure online portal. Blinding As baseline assessment of participants is carried out prior to randomisation, there is no risk of disclosure of treatment allocation to the assessor at the time. Use of remote assessments, initiated through automated email, will rule out any potential effects of assessors on assessments of outcomes. The statisticians will remain blind to treatment allocation throughout the analysis. |
| Intervention type | Behavioural |
| Primary outcome measure | Depressive symptomatology as assessed using the PHQ-9 at baseline and 34 weeks post-randomisation |
| Secondary outcome measures | 1. Depressive symptomatology as assessed using the PHQ-9 at baseline and 10 weeks post-randomisation 2. Service-use information will be collected using the Adults Service Use Schedule throughout the study |
| Overall study start date | 01/01/2021 |
| Overall study end date | 23/10/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 234; UK Sample Size: 234 |
| Total final enrolment | 259 |
| Participant inclusion criteria | Current inclusion criteria as of 04/01/2022: 1. Non-response to a minimal effective dose of high-intensity treatment in IAPT (at least 12 sessions, in line with NICE draft guideline suggestions) defined in line with the caseness threshold adopted by IAPT as a Patient Health Questionnaire-9 (PHQ-9) score of 10 or higher 2. Meeting criteria for a current episode of Major Depression according to DSM-5 as assessed through the Mini International Neuropsychiatric Interview for DSM-5 (MINI) 3. Aged 18 years or older 4. Access to a working internet connection to participate in video conferencing assessments and interventions. According to the IAPT database, the majority of patients who receive high-intensity psychological treatment will also have received treatment with antidepressant medication, and most of these patients will therefore meet consensus criteria for treatment resistance _____ Previous inclusion criteria: 1. Non-response to a minimal effective dose of high-intensity treatment in IAPT (at least 12 sessions, in line with NICE draft guideline suggestions) defined in line with the caseness threshold adopted by IAPT as a Patient Health Questionnaire-9 (PHQ-9) score of 10 or higher 2. Meeting criteria for a current episode of Major Depression according to DSM-5 as assessed through the Mini International Neuropsychiatric Interview for DSM-5 (MINI) 3. Age between 18 and 65 years 4. Access to a working internet connection to participate in video conferencing assessments and interventions. According to the IAPT database, the majority of patients who receive high-intensity psychological treatment will also have received treatment with antidepressant medication, and most of these patients will therefore meet consensus criteria for treatment resistance |
| Participant exclusion criteria | Current exclusion criteria as of 04/01/2022: 1. Based on the judgment of their IAPT therapist they are eligible for secondary care specialist services 2. Receiving individual psychotherapy or counselling from other sources than the NHS at a frequency of more than once a month 3. They present with a level of risk to self or others that cannot be safely managed in a primary care service context (i.e. active suicidal plans), a history of psychosis or psychotic symptoms, a current episode of mania, alcohol or substance abuse or dependence within the past 3 months, current post-traumatic stress disorder, obsessive-compulsive disorder or eating disorder 4. They suffer from any other significant disease or disorder that may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial 5. Have an insufficient ability to understand or read English 6. Patients who are currently taking antidepressant medication will be allowed into the trial and medication use will be documented for statistical analysis _____ Previous exclusion criteria: 1. Based on the judgment of their IAPT therapist they are eligible for secondary care specialist services 2. Receiving individual psychotherapy or counselling from other sources than the NHS at a frequency ofmore than once a month 3. Report the presence of active suicidal plans, a history of psychosis or psychotic symptoms, a current episode of mania, alcohol or substance abuse or dependence within the past 3 months 4. Suffer from severe medical illness 5. Have an insufficient ability to understand or read English. Patients who are currently taking antidepressant medication will be allowed into the trial and medication use will be documented for statistical analysis |
| Recruitment start date | 09/06/2021 |
| Recruitment end date | 24/01/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Sussex Partnership NHS Foundation Trust Assessment and Treatment Centre
Chapel Street
Chichester
PO19 1BX
United Kingdom
Chichester
PO19 1BX
United Kingdom
Devon Partnership NHS Trust
Research and Development Team
Wonford House
Dryden Road
Exeter
EX2 5AF
United Kingdom
Wonford House
Dryden Road
Exeter
EX2 5AF
United Kingdom
Institute of Psychiatry, Psychology & Neuroscience
South London and Maudsley NHS Foundation Trust
Research and Development Office
King’s College London
Denmark Hill Campus
16 De Crespigny Park
London
SE5 8AF
United Kingdom
Research and Development Office
King’s College London
Denmark Hill Campus
16 De Crespigny Park
London
SE5 8AF
United Kingdom
Sponsor information
Sussex Partnership NHS Foundation Trust
Hospital/treatment centre
Hospital/treatment centre
Trust Hq
Swandean
Arundel Road
Worthing
BN13 3EP
England
United Kingdom
| Phone | +44(0)300 3040088 |
|---|---|
| researchgovernance@sussexpartnership.nhs.uk | |
| Website | http://www.sussexpartnership.nhs.uk/ |
"ROR" |
https://ror.org/05fmrjg27 |
Funders
Funder type
Government
NIHR Central Commissioning Facility (CCF); Grant Codes: NIHR200750
No information available
National Institute for Health Research (NIHR) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Results of the study will be shared with the general public through publications, presentations, social media and workshops. We will aim to publish the main results of the trial in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the trial will be stored in a non-publicly available repository at Sussex Partnership NHS Foundation Trust upon publication of main study results. Anonymised data may be accessed and analysed by members of the project team and by researchers collaborating with members of the project team on the analysis of these data. Data sharing will be enabled using a controlled access model in line with Good Practice Principles for Sharing Individual Participant Data from Publicly Funded Clinical Trials from the UK Medical Research Council. Scientists seeking to access the data for use in future projects must do so via request to the CI and projects using the data must have been approved in accordance with contemporary UK ethical and regulatory processes pertaining to the release of anonymised data under these circumstances. We will follow current recommendations on anonymizing and curating trial data for sharing. Research data with personal information removed and replaced through a code and original research records, including video recordings of assessment interviews and therapy sessions, will be retained for 10 years, before being destroyed and retained in electronic form. The electronic records will be kept for 10 years after the end of the study. Publications will not contain any patient-identifiable information. (added 05/01/2022) The datasets generated during and/or analysed during the current study are/will be available upon request from the CI, Thorsten Barnhofer (t.barnhofer@surrey.ac.uk) . Projects using the data must have been approved in accordance with contemporary UK ethical and regulatory processes pertaining to the release of anonymised data under these circumstances. We will follow current recommendations on anonymizing and curating trial data for sharing. Consent for data sharing has been obtained from participants and anonymised data will be retained for 10 years. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v01.2 | 21/01/2021 | 02/03/2021 | No | Yes |
| Protocol file | version v01.3 | 11/02/2021 | 02/03/2021 | No | No |
| Participant information sheet | version 1.3 | 21/04/2021 | 03/10/2022 | No | Yes |
| Participant information sheet | version 1.4 | 11/05/2021 | 03/10/2022 | No | Yes |
| Participant information sheet | version 1.5 | 28/07/2021 | 03/10/2022 | No | Yes |
| Participant information sheet | version 1.6 | 07/11/2021 | 03/10/2022 | No | Yes |
| Protocol file | version 1.4 | 21/04/2021 | 03/10/2022 | No | No |
| Protocol file | version 1.5 | 12/05/2021 | 03/10/2022 | No | No |
| Protocol file | version 1.6 | 17/08/2021 | 03/10/2022 | No | No |
| Protocol file | version 2.0 | 11/11/2021 | 03/10/2022 | No | No |
| Protocol file | version 2.1 | 03/07/2022 | 03/10/2022 | No | No |
| Protocol article | 19/01/2023 | 23/01/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Statistical Analysis Plan | version 1.0 | 14/07/2023 | No | No |
Additional files
- ISRCTN17755571_PROTOCOL_v01.3_11Feb2021.docx
- uploaded 02/03/2021
- ISRCTN17755571_PIS_v01.2_21Jan21.docx
- uploaded 02/03/2021
- ISRCTN17755571_PIS_v1.3_21Apr21.pdf
- ISRCTN17755571_PIS_v1.4_11May21.pdf
- ISRCTN17755571_PIS_v1.5_28Jul21.pdf
- ISRCTN17755571_PIS_v1.6_07Nov21.pdf
- ISRCTN17755571_Protocol_v1.4_21Apr21.pdf
- ISRCTN17755571_Protocol_v1.5_12May21.pdf
- ISRCTN17755571_Protocol_v1.6_17Aug21.pdf
- ISRCTN17755571_Protocol_v2.0_11Nov21.pdf
- ISRCTN17755571_Protocol_v2.1_03Jul22.pdf
- 39306 RESPONDS_SAP_v1.0.pdf
Editorial Notes
16/09/2024: The intention to publish date was changed from 31/08/2024 to 31/12/2024.
13/03/2024: The following changes were made:
1. The overall end date was changed from 31/01/2024 to 23/10/2023.
2. The intention to publish date was changed from 31/05/2024 to 31/08/2024.
3. A ClinicalTrials.gov number was added.
4. A scientific contact was removed.
14/07/2023: The following changes were made to the trial record:
1. The overall end date was changed from 30/09/2023 to 31/01/2024.
2. The intention to publish date was changed from 31/12/2023 to 31/05/2024.
3. The plain English summary was updated to reflect these changes.
4. The statistical analysis plan was uploaded as an additional file.
24/04/2023: The recruitment end date was changed from 30/09/2023 to 24/01/2023. Total final enrolment added.
23/01/2023: Publication reference added.
04/10/2022: The recruitment start date has been changed from 01/03/2021 to 09/06/2021.
03/10/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/05/2022 to 30/09/2023.
2. The overall trial end date has been changed from 31/12/2022 to 30/09/2023 and the plain English summary has been updated to reflect this change.
3. The intervention has been updated.
4. The protocols (not peer-reviewed) have been uploaded as additional files.
5. The participant information sheets have been uploaded as additional files.
6. The study contact has been updated.
7. The IRAS number has been added.
05/01/2022: The IPD sharing statement was updated.
04/01/2022: The following changes have been made:
1. The trial acronym has been added.
2. The participant inclusion criteria have been changed.
3. The participant exclusion criteria have been changed.
4. The recruitment end date has been changed from 31/12/2021 to 31/05/2022.
02/03/2021: The following changes were made to the trial record:
1. The participant information sheet was uploaded.
2. Uploaded protocol (not peer reviewed) Version 01.3, 11 February 2021.
21/01/2021: Trial’s existence confirmed by National Institute for Health Research (NIHR)
