Testing a psychological training intervention for physiotherapy students; a randomized control trial

ISRCTN ISRCTN13368968
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Study website

Contact information

Dr Andrew Soundy
Scientific

Principal Investigator
School of Sport, Exercise and Rehabilitation Sciences
University of Birmingham
Birmingham
B15 2TT
United Kingdom

ORCiD logoORCID ID 0000-0002-5118-5872
Phone +44 (0)1214148385
Email A.A.Soundy@bham.ac.uk

Study information

Study designExternal Pilot randomised control trial with parallel groups
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Other
Study typeOther
Participant information sheet https://www.meah.rocks/information-sheet-for-porject-meah1
Scientific titleTesting the model of emotion, adaptation and hope (MEAH) training for physiotherapy students; a randomized control trial
Study acronymMEAH1
Study objectivesThat 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) studiedStudent physiotherapists
InterventionThe 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 typeBehavioural
Primary outcome measureEmpathy measured using the interpersonal reactivity index at pre and post intervention then at follow up at 6 weeks
Secondary outcome measures1. 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 date17/02/2020
Completion date01/12/2020

Eligibility

Participant type(s)Other
Age groupAdult
SexBoth
Target number of participants24-30
Key inclusion criteriaCurrent 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 criteriaCurrent 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 enrolment01/04/2020
Date of final enrolment01/07/2020

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Birmingham
School of Sport, Exercise and Rehabilitation Sciences
Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham
University/education

School of Sport, Exercise, and Rehabilitation Sciences
Birmingham
B15 2TT
England
United Kingdom

Phone +44 (0)1214148385
Email A.A.Soundy@bham.ac.uk
Website http://www.birmingham.ac.uk/index.aspx
ROR logo "ROR" https://ror.org/03angcq70

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/09/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal and conference presentation of results
IPD sharing planThe 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?
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.