Testing a psychological training intervention for physiotherapy students; a randomized control trial
ISRCTN | ISRCTN13368968 |
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DOI | https://doi.org/10.1186/ISRCTN13368968 |
Secondary identifying numbers | 1.0 |
- Submission date
- 18/02/2020
- Registration date
- 19/02/2020
- Last edited
- 18/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Physiotherapy students need to understand the basic principles of psychological care for patients. Aspects of psychological care have been missing from the education of physiotherapists traditionally. However, the organisations which govern the professional support the need for this type of education. Currently, there is no standardised approach for how skills provided to psychological support patients is and care is taught during the physiotherapy course across the UK. Research is needed that establishes what psychological skills training physiotherapists are required to have. Basic skills include empathy and listening and both aspects of communication are needed for patients to feel trust and be able to feel confident to tackle their own challenges during rehabilitation. Past review evidence has suggested that students feel underprepared to deliver basic communication to patients. However, there is evidence to show that even a single training session can improve empathy in physiotherapy students. Further research is needed that has theory and practical application of skills as part of the psychological training. The model of emotions, adaptation and hope (MEAH) provides this. Researchers have developed a single session of training that can educate physiotherapy students and improve care but this work needs testing. The aim of this study is to test the content of MEAH training against a standard communication skills training session across all years of physiotherapy students based at Birmingham to see if the training can improve empathy and other psychological indices important for patient care.
Who can participate?
Student physiotherapists from the University of Birmingham who are registered on the pre-registration programmes
What does the study involve?
Students will be allocated to either the education as normal group or the intervention group (with MEAH training). The intervention group will receive a single 2-hour training session around the model of emotions, adaptation and hope. This will include how the model differs from current understanding of psychological adaptation, how the model links to illness stories, how the model can be used for screening and as the basis for a psychological intervention. Students allocated to the education as normal group will receive THE standard communication lecture that is given within the first year of the program.
What are the possible benefits and risks of participating?
Benefits include students being better at clinical communication and understanding of how psychological adaptation is important for people they treat. It also could impact on health outcomes for the patient and the student. Risks are small. Part of the training will ask students to consider their own current challenges to reflect on these. The training is about how to adapt to such situations so this could cause distress but none was reported within the feasibility study.
Where is the study run from?
University of Birmingham (UK)
When is the study starting and how long is it expected to run for?
February 2020 to December 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Andrew Soundy
a.a.soundy@bham.ac.uk
Contact information
Scientific
Principal Investigator
School of Sport, Exercise and Rehabilitation Sciences
University of Birmingham
Birmingham
B15 2TT
United Kingdom
0000-0002-5118-5872 | |
Phone | +44 (0)1214148385 |
A.A.Soundy@bham.ac.uk |
Study information
Study design | External Pilot randomised control trial with parallel groups |
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Primary study design | Interventional |
Secondary study design | Randomised parallel trial |
Study setting(s) | Other |
Study type | Other |
Participant information sheet | https://www.meah.rocks/information-sheet-for-porject-meah1 |
Scientific title | Testing the model of emotion, adaptation and hope (MEAH) training for physiotherapy students; a randomized control trial |
Study acronym | MEAH1 |
Study objectives | That the MEAH training will have a greater impact on empathy and other indices when compared to a standard communication teaching session. |
Ethics approval(s) | Approved 26/02/2020, Science, Technology, Engineering and Mathematics Ethical Review Committee, University of Birmingham (Aston Webb Building, University of Birmingham, Edgbaston B15 2TT UK; +44 0121 414 8825; s.l.cottam@bham.ac.uk), ref: ERN_18-1970B |
Health condition(s) or problem(s) studied | Student physiotherapists |
Intervention | The method of randomisation will be simple randomisation but the researchers will use randomised block sizes to allocate. Intervention: Students will be asked to consent to take part in a study and given the information sheet at the start of a whole cohort lecture. After 48 hours students will be allocated to a single two-hour lecture of training around mental health, psychological adaptation, hope and illness stories Control: After 48 hours students will be allocated to a control group that will receive standard communication lecture that is given within the first year of the program. The duration of the intervention is 2 hours. Assessments will take place pre intervention, immediately post intervention and at 6 weeks follow up. |
Intervention type | Behavioural |
Primary outcome measure | Empathy measured using the interpersonal reactivity index at pre and post intervention then at follow up at 6 weeks |
Secondary outcome measures | 1. Student attitudes towards the treatment of people with mental illness, measured using the Mental Illness Clinicians’ Attitudes Scale (MICA) at pre and post-intervention then at follow up at 6 weeks 2. Attitudes towards treatment, measured using the open minds scale for health care providers at pre and post-intervention then at follow up at 6 weeks 3. Self-confidence measured using the General Self Efficacy Scale (GSE) at pre and post-intervention then at follow up at 6 weeks 4. Communication practices linked to students in health care, measured using the Froehlich Communication Survey at pre and post-intervention then at follow up at 6 weeks |
Overall study start date | 17/02/2020 |
Completion date | 01/12/2020 |
Eligibility
Participant type(s) | Other |
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Age group | Adult |
Sex | Both |
Target number of participants | 24-30 |
Key inclusion criteria | Current participant inclusion criteria as of 27/04/2020: 1. Studying for a degree in physiotherapy at the University of Birmingham 2. Able and happy to consent Previous participant inclusion criteria: 1. Studying for a degree in physiotherapy at the University of Birmingham 2. Studying on a pre-registration program 3. Able and happy to consent |
Key exclusion criteria | Current participant exclusion criteria as of 27/04/2020: 1. Not based at the University of Birmingham 2. Unable to consent 3. Currently taking part in other communication or psychological based interventions Previous participant exclusion criteria: 1. Not based at the University of Birmingham 2. Unable to consent |
Date of first enrolment | 01/04/2020 |
Date of final enrolment | 01/07/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Birmingham
B15 2TT
United Kingdom
Sponsor information
University/education
School of Sport, Exercise, and Rehabilitation Sciences
Birmingham
B15 2TT
England
United Kingdom
Phone | +44 (0)1214148385 |
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A.A.Soundy@bham.ac.uk | |
Website | http://www.birmingham.ac.uk/index.aspx |
https://ror.org/03angcq70 |
Funders
Funder type
Other
No information available
Results and Publications
Intention to publish date | 01/09/2020 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal and conference presentation of results |
IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Andrew Soundy (a.a.soundy@bham.ac.uk). The data will be limited to anonymised data which relates only to published work. Published work will have supplementary files which will include this data as well. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | 20/01/2021 | 18/01/2022 | Yes | No |
Editorial Notes
18/01/2022: Publication reference added.
16/07/2021: Internal review.
23/03/2021: Internal review.
28/04/2020: The ethics approval has been added.
27/04/2020: The following changes have been made:
1. The study design has been changed from "Randomised control trial with parallel groups" to "External Pilot randomised control trial with parallel groups".
2. The participant inclusion criteria have been updated.
3. The participant exclusion criteria have been updated.
4. The target number of participants has been changed from "125" to "24-30".
5. The total target enrolment has been changed from "125" to "24".
19/02/2020: Trial's existence confirmed by University of Birmingham Ethics Committee.