The feasibility of student physiotherapists delivering a brief psychological intervention to stroke patients
| ISRCTN | ISRCTN14244302 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14244302 |
- Submission date
- 21/10/2020
- Registration date
- 16/11/2020
- Last edited
- 16/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Current plain English summary as of 23/03/2021:
Background and study aims
We have undertaken several research studies, which, when combined, have given us a new model to guide specialist practice and training, the Model of Emotions, Adaptation and Hope (MEAH). The MEAH allows us to provide a single e-learning training session which includes: (a) an introduction to the mental health screening of student physiotherapists by self-completing the MEAH questionnaire and considering an introduction to scale (b) teaching of a storytelling-based therapy (underpinned by the MEAH model to enhance interactions) (c) applying the training to a selected group of people with chronic illnesses (individuals identified from the people in research website). We have named this e-learning training package, the Screen, Intervene, and Train (SIT) approach to care. Our past pilot research (Soundy et al., 2020; 2021) has tested the effectiveness of training from a student perspective and research is needed to consider if students can apply the training themselves to participants and consider the feasibility of this.
Our primary aim is to assess the feasibility of students delivering the intervention on people with stroke. We will assess three outcome measures, feasibility related outcomes and consider the therapeutic conversations and record a a single interview with both students and people with stroke post intervention.
Who can participate?
The study will use MEAH trained student physiotherapists who volunteer to provide a screening interview to an individual with stroke.
What does the study involve?
The planned study requires people with Stroke to be allocated to either a control group (waiting list control) or the intervention group (with MEAH training). Patient assessment will take place before and after the intervention. The waiting list control group will receive the MEAH as soon as they would like after completing the post assessment (i.e. 15 minutes after this if required or desired).
What are the possible benefits and risks of participating?
The most direct benefits include; (a) improved mental health for student physiotherapists and participants. (b) empowerment of participants to seek positive coping behaviours, reducing the need for additional costly healthcare services for student physiotherapists and potentially patients. (c) increase resilience of student physiotherapists and reduced burn out (d) improve patient satisfaction and (e) reduced need for pharmacological approaches to treat mental illness student physiotherapists (f) reduced work absence and improved productivity of student physiotherapists and (g) possibility of a new model for clinical placement and experience for students.
The potential risk is that people with stroke are asked to reflect on a current difficulty and rate it. The interview process could bring up memories which cause upset or distress. Our pilot research and patient and participant involvement sessions identified no adverse event however.
When is the study running from?
University of Birmingham (UK)
When is the study starting and how long is it expected to run for?
September 2020 to November 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr A Soundy
A.A.Soundy@bham.ac.uk
Previous plain English summary:
Background and study aims
Currently, student Health Care Professionals (SHCPs) face distinct and unique pressures on their mental health and are experiencing poorer mental health, such as heightened levels of anxiety and depression. Part of this is a result of the interactions that they are required to have with patients and families via remote means (e.g. by phone) due to social distancing and which is highly pressured and intense given the unforeseen impact of the COVID-19 pandemic. The researchers have undertaken many small research studies, which, when combined, have given them a new model to guide specialist practice and training, the Model of Emotions, Adaptation and Hope (MEAH). The MEAH allows the researchers to provide a single e-learning training session which includes: (a) mental health screening of SHCP by self-completing the MEAH questionnaire, (b) a brief mental health intervention involving a 20-minute e-based or telephone call around the screening and (c) teaching of a storytelling-based therapy (underpinned by the MEAH model to enhance interactions). They have named this e-learning training package the Screen, Intervene, and Train (SIT) approach to care. The aim of this study is to investigate the impact of a 2-hour MEAH e-learning training session on depression and anxiety of SHCPs.
Who can participate?
Students who are completing a UK health care course at a participating university
What does the study involve?
Students participate in one of three groups for a period of 2 hours. All active groups or interventions are delivered virtually. The SIT intervention will include a single screening interview taking 20 minutes with Dr A Soundy. Following this, the participant will be sent a pre-recorded e-based training session. The lecture takes 45 minutes. The indicative content considers examples of interactions, the science behind the MEAH, the use of screening and how to engage in a brief narrative-based intervention within practice. It has the same components as the pilot studies, although adapted into one training session. The final part of the training for SHCP will include an e-learning presentation. The presentation will provide an analysis of the screening calls. This will reveal the most common difficulties and stories expressed within screening and will summarise the difficulties that were challenging to adapt to, an illustration of how the MEAH is important for this understanding and the most common coping strategies identified (this was undertaken and achieved as part of the pilot research to consolidate learning). The principles are that sharing this information will provide direct access to others' experiences which has been associated with enhanced mental health outcomes. The benefit of this is SHCP can access effective coping strategies that promote mental health and psychological well-being outcomes. This entire process will take a maximum of 2 hours to complete at a pace and time that is convenient for the participant. The inactive waiting list control group will receive or be offered the SIT intervention at week 12. Individuals in this group will receive or be offered the SIT intervention at week 12. The follow-up assessment for all groups will be at 3 months.
What are the possible benefits and risks of participating?
There may be mental health benefits for the student with improved communication skills and better psychological care for the patient.
Where is the study run from?
University of Birmingham (UK)
When is the study starting and how long is it expected to run for?
September 2020 to September 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr A Soundy
A.A.Soundy@bham.ac.uk
Contact information
Scientific
School of Sport, Exercise and Rehabilitation Sciences
Birmingham
B15 2TT
United Kingdom
 ORCID ID |
0000-0002-5118-5872 |
|---|---|
| Phone | +44 (0)121 4148385 |
| A.A.Soundy@bham.ac.uk |
Study information
| Study design | Single centre multi method study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Internet/virtual |
| Study type | Other |
| Participant information sheet | https://www.meah.rocks/information-sheet-national-student- |
| Scientific title | The feasibility of Student Physiotherapists of delivering a brief psychological intervention; a feasibility study |
| Study acronym | PT-MEAH |
| Study hypothesis | Current study hypothesis as of 23/03/2021: Student health care professionals who are trained to use the model of emotions, adaptation and hope are able to effectively support participants with stroke. Previous study hypothesis as of 08/01/2021: Student health care professionals who are training using the model of emotions, adaptation and hope will obtain mental health and interactional benefits compared to a waiting list control condition. Previous study hypothesis: Student health care professionals who are training using the model of emotions, adaptation and hope will obtain mental health and interactional benefits compared to motivational interviewing and a waiting list control condition. |
| Ethics approval(s) | Current ethics approval as of 23/03/2021: Approval pending, Science, Technology, Engineering and Mathematics Ethical Review Committee (Research Support Group, C Block Dome, Aston Webb Building, University of Birmingham, Edgbaston, B15 2TT, UK; +44 (0)121 414 8825; s.l.cottam@bham.ac.uk), ref: ERN_18-1970E Previous ethics approval: Approved 29/09/2019, Science, Technology, Engineering and Mathematics Ethical Review Committee (Research Support Group, C Block Dome, Aston Webb Building, University of Birmingham, Edgbaston, B15 2TT, UK; +44 (0)121 414 8825; s.l.cottam@bham.ac.uk), ref: ERN_18-1970D |
| Condition | Training of student health care professionals to deliver support to people with stroke |
| Intervention | Current interventions as of 23/03/2021: Stroke participants will be required to complete baseline outcome measure and then will be randomised to either an intervention condition or waiting list control (15-minute wait). For the intervention group, trained physiotherapy students will provide a brief (5 - 15 minute) one-to-one video intervention. After the intervention the measures will be repeated. The training provided to the students will include a single screening interview taking 20 minutes with Dr A Soundy. Following this, the participant will be sent a pre-recorded e-based training session. The lecture takes 45 minutes. The indicative content considers examples of interactions, the science behind the MEAH, the use of screening and how to engage in a brief narrative-based intervention within practice. It has the same components as the pilot studies, although adapted into one training session. The final part of the training for SHCP will include an e-learning presentation. The presentation will provide an analysis of the screening calls. This will reveal the most common difficulties and stories expressed within screening and will summarise the difficulties that were challenging to adapt to, an illustration of how the MEAH is important for this understanding and the most common coping strategies identified (this was undertaken and achieved as part of the pilot research to consolidate learning). The principles are that sharing this information will provide direct access to others' experiences which has been associated with enhanced mental health outcomes (Ooms et al., 2016; Soundy et al., 2019). The benefit of this is SHCP can access effective coping strategies that promote mental health and psychological well-being outcomes. This entire process will take a maximum of two hours to complete at a pace and time that is convenient for the participant. Previous interventions as of 08/01/2021: Group 1. Model of emotions, adaptation and hope Group 2. Waiting list control Group 1 intervention: the SIT intervention will include a single screening interview taking 20 minutes with Dr A Soundy. Following this, the participant will be sent a pre-recorded e-based training session. The lecture takes 45 minutes. The indicative content considers examples of interactions, the science behind the MEAH, the use of screening and how to engage in a brief narrative-based intervention within practice. It has the same components as the pilot studies, although adapted into one training session. The final part of the training for SHCP will include an e-learning presentation. The presentation will provide an analysis of the screening calls. This will reveal the most common difficulties and stories expressed within screening and will summarise the difficulties that were challenging to adapt to, an illustration of how the MEAH is important for this understanding and the most common coping strategies identified (this was undertaken and achieved as part of the pilot research to consolidate learning). The principles are that sharing this information will provide direct access to others' experiences which has been associated with enhanced mental health outcomes (Ooms et al., 2016; Soundy et al., 2019). The benefit of this is SHCP can access effective coping strategies that promote mental health and psychological well-being outcomes. This entire process will take a maximum of two hours to complete at a pace and time that is convenient for the participant. Group 2 inactive control: an inactive waiting list control group will be used. Individuals in this group will receive or be offered the SIT intervention at week 12. Previous interventions: Group 1. Model of emotions, adaptation and hope Group 2. Motivational interviewing Group 3. Waiting list control Intervention: The SIT intervention will include a single screening interview taking 20 minutes with Dr A Soundy. Following this, the participant will be sent a pre-recorded e-based training session. The lecture takes 45 minutes. The indicative content considers examples of interactions, the science behind the MEAH, the use of screening and how to engage in a brief narrative-based intervention within practice. It has the same components as the pilot studies, although adapted into one training session. The final part of the training for SHCP will include an e-learning presentation. The presentation will provide an analysis of the screening calls. This will reveal the most common difficulties and stories expressed within screening and will summarise the difficulties that were challenging to adapt to, an illustration of how the MEAH is important for this understanding and the most common coping strategies identified (this was undertaken and achieved as part of the pilot research to consolidate learning). The principles are that sharing this information will provide direct access to others' experiences which has been associated with enhanced mental health outcomes (Ooms et al., 2016; Soundy et al., 2019). The benefit of this is SHCP can access effective coping strategies that promote mental health and psychological well-being outcomes. This entire process will take a maximum of two hours to complete at a pace and time that is convenient for the participant. Inactive control group 1: an inactive waiting list control group will be used. Individuals in this group will receive or be offered the SIT intervention at week 12. Active control group 2: an alternative e-intervention will be used which includes a 45-minute pre-recorded lecture. Individuals in this group will receive or be offered the SIT intervention at week 12. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measure as of 23/03/2021: Patient-reported outcome measures will be taken before and after the intervention: 1. Fatigue measured using the fatigue severity scale 2. Impact of health on an individual's everyday life measured using the SF-12 3. Emotions, adaptation and hope measured using the MEAH version 3.3 (made up of the hope and adaptation scale (Soundy et al., 2016) and the circumplex model of affect (Russell, 1980) ) Previous primary outcome measure: Depression and anxiety measured using The Hospital Anxiety and Depression Scale (HADS) pre, immediately post intervention, and at 12 weeks |
| Secondary outcome measures | Current secondary outcome measures as of 23/03/2021: 1. Personal perceptions and experiences of the process and how it could fit into everyday practice for physiotherapist measured using student physiotherapist and patient interviews will be undertaken after the intervention 2. Interactions will be recorded to analyse if the student can apply the principles of the training and manage interactions using the MEAH Previous secondary outcome measures: Measured pre, immediately post intervention, and at 12 weeks: 1. Quality of life measured using the SF-12 quality of life questionnaire 2. Stigmatising attitudes and intentions of behaviour measured using the open minds scale for health care providers 3. Communication assessed using the Froehlich Communication Survey 4. Empathy measured using the interpersonal reactivity index 5. Hope measured using the Adult Hope Scale 6. Emotions, adaptation and hope measured using the MEAH version 3.3 |
| Overall study start date | 01/09/2020 |
| Overall study end date | 01/11/2021 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Participant inclusion criteria | Current inclusion criteria as of 23/03/2021: 1. Students 1.1. Have received MEAH training 1.2. Currently completing a BSc Physiotherapy degree 2. People with stroke 2.1. Not currently an NHS patient 2.2. No cognitive impairments 2.3. Community dwelling Previous participant inclusion criteria as of 08/01/2021: Any student health care professional currently studying at one of the following Universities: 1. University of Birmingham 2. Winchester University 3. Oxford Brookes University Previous participant inclusion criteria: Any student health care professional currently studying at one of the following Universities: 1. Southampton University 2. Birmingham City University 3. Oxford Brookes University 4. Coventry University 5. Nottingham University |
| Participant exclusion criteria | Current exclusion criteria as of 23/03/2021: 1. Student Participated in the pilot study or received training related to the model previously in any form 2. People with stroke Does not meet inclusion criteria Previous participant exclusion criteria as of 08/01/2021: 1. Participated in the pilot study or received training related to the model previously in any form Previous participant exclusion criteria: 1. Participated in the pilot study |
| Recruitment start date | 01/05/2021 |
| Recruitment end date | 01/11/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Brimingham
B15 2TT
United Kingdom
University of Winchester
103-104 The High Street
Wincester
SO23 9AH
United Kingdom
Headington
Oxford
OX3 0BP
United Kingdom
Boscombe
Bournemouth
BH1 3LH
United Kingdom
Sponsor information
University/education
c/o Clarke Crawford
University of Birmingham Medical School
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 (0)1214147678 |
|---|---|
| C.J.Crawford@bham.ac.uk | |
| Website | http://www.birmingham.ac.uk/index.aspx |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version v2.6 | 08/09/2020 | 02/12/2020 | No | No |
Additional files
- ISRCTN14244302_PROTOCOL_v2.6 08Sept2020 .pdf
- Uploaded 02/12/2020
Editorial Notes
16/11/2021: Internal review.
23/03/2021: The following changes were made to the trial record following a major amendment:
1. The public title was changed from "Mental health and interaction training for student health care professionals" to "The feasibility of student physiotherapists delivering a brief psychological intervention to stroke patients".
2. The scientific title was changed from "Mental Health Screening, Intervening and Training (SIT) of student health care professionals; a multi-methods study" to "The feasibility of Student Physiotherapists of delivering a brief psychological intervention; a feasibility study".
3. The ethics details were updated.
4. The acronym was changed from "SIT to "PT-MEAH"
5. The study hypothesis was changed.
6. The study design was changed from "Multi-centre two-arm non-randomized trial" to "Single centre multi method study"
7. The condition was changed from "Mental health of student health care professionals" to "Training of student health care professionals to deliver support to people with stroke".
8. The condition category was changed from "Mental and behavioural disorders" to "Not applicable"
9. The interventions were changed.
10. The primary outcome measure was changed.
11. The secondary outcome measures were changed.
12. The participant type was changed from "Health professionals" to "Mixed"
13. The inclusion criteria were changed.
14. The exclusion criteria were changed.
15. The target number of participants, was changed from 280 to 30.
16. The recruitment start date was changed from 14/01/2021 to 01/05/2021.
17. The recruitment end date was changed from 07/06/2021 to 01/11/2021.
18. The trial participating centre University of Bournemouth was added.
19. The overall end date was changed from 01/09/2021 to 01/11/2021.
20. The plain English summary was updated to reflect these changes.
21. The intention to publish date was changed from 01/03/2021 to 01/12/2021.
08/01/2021: The following changes have been made:
1.The study hypothesis has been updated.
2. The interventions have been updated and the plain English summary updated accordingly
3. The participant inclusion criteria have been updated.
4. The participant exclusion criteria have been updated.
5. The trial participating centres "Faculty of Health and Well Being" and "Oxford Brookes University" have been added and the trial participating centre "School of Health Sciences" has been removed.
6. The recruitment start date has been changed from 26/10/2020 to 14/01/2021.
7. The intention to publish date has been changed from 01/03/2020 to 01/03/2021.
8. The study design has been changed from "Multi-centre randomized controlled trial" to "Multi-centre two-arm non-randomized trial".
9. The secondary study design has been changed from "Randomised parallel trial" to "Non randomised study".
10. The trial setting has been changed from "Other" to "Internet".
02/12/2020: Uploaded protocol version 2.6, 8 September 2020 (not peer reviewed).
11/11/2020: Trial's existence confirmed by the Science, Technology, Engineering and Mathematics Ethical Review Committee.
