Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377709
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-04-17
Brief Title:
A Mixed-methods Acceptability Study of ProACTive to Help Burns Patients Adjust to Changes to Appearance
Sponsor:
Nottingham University Hospitals NHS Trust
Organization:
Nottingham University Hospitals NHS Trust
Study Overview
Official Title:
A Mixed-methods Acceptability Study of ProACTive an Early Acceptance and Commitment Therapy Intervention to Help Burns Patients Adjust to Changes to Appearance
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This mixed-methods acceptability study aims to investigate whether an early acceptance and commitment therapy ACT based intervention called ProACTive aimed at supporting burns patients adjustment to a changed appearance and preventing distress is acceptable This will be measured by descriptive data questionnaire data and semi-structured interviews
Preliminary data on the potential clinical effectiveness of the intervention will also be gathered This will be measured by scores on standardised questionnaires
Preliminary data on the potential clinical effectiveness of the intervention will also be gathered This will be measured by scores on standardised questionnaires
Detailed Description:
Evidence suggests that appearance concerns after burn injuries start early Appearance concerns can be chronic create psychological distress and impact quality of life No early psychological interventions for appearance concerns after burn injuries currently exist
ProACTive a novel psychological intervention talking therapy utilising acceptance and commitment therapy ACT techniques with an additional focus on developing self-compassion and social skills training was developed It aims to help burns patients adjust to changes to appearance and prevent distress It involves up to five 30-minute modules and patients can select how many and which modules to complete It is delivered by a psychological professional working in burns services
The primary aim of this study is to explore whether the ProACTive intervention is acceptable to burns patients A secondary objective is to gather preliminary data on the potential clinical effectiveness of the ProACTive intervention
A mixed-methods single-arm acceptability study will be conducted
ProACTive will be offered to burns patients aged 18 years or over meeting inclusion criteria and admitted to the burns service at Nottingham University Hospitals NHS Trust
Fifteen participants will be recruited to complete the intervention
The primary objective of exploring the acceptability of the ProACTive intervention will be measured by
Intervention update rate percentage of those invited to participate in the study
Descriptive data about reasons for not taking up the intervention if patients consent to participating in the study in this way
Patient feedback gathered through a semi-structured exit interview as soon as possible after the intervention ends within two weeks
Patient feedback gathered using a standardised self-report questionnaire to record helpful and hindering aspects of the intervention will be completed after every session completed
Descriptive data about how many and which of the sessions patients choose to complete and the spacing of sessions completed
The number of sessions completed during hospital admission and after hospital discharge and whether these were completed face to face or virtually
Descriptive data about participants preferences for receiving the post-session resources in paper or electronic format
The number of times participants viewed the post-session online videos containing audio-exercises
Descriptive data about reason for ending the intervention before all sessions have been completed
Template analysis King 2012 a form of thematic analysis Braun Clarke 2006 will be used to analyse patterns of meaning or themes within the transcripts of the interviews The Theoretical Framework of Acceptability TFA Sekhon et al 2017 will also be used to develop the interview schedule and the initial coding template
The secondary objective to gather preliminary data on the potential clinical effectiveness of the ProACTive intervention will be examined through scores on four standardised self-report measures of
Appearance concerns
Positive and negative affect
Psychological flexibility
Self-compassion
These measures will be completed before and after the intervention Wilcoxon tests will be used to compare pre- and post-intervention scores These exploratory analyses will indicate the extent to which appearance concerns decrease and psychological flexibility and self-compassion increase post-intervention compared to pre-intervention Differences between pre- and post-intervention means will also give an indication of the likely effect size of the intervention Cohens d
The outcome of the study will include knowledge about whether ProACTive is acceptable to burns patients when it is introduced during hospital admission and preliminary evidence about the effectiveness of ProACTive These outcomes will contribute to further intervention refinement and trial development
ProACTive a novel psychological intervention talking therapy utilising acceptance and commitment therapy ACT techniques with an additional focus on developing self-compassion and social skills training was developed It aims to help burns patients adjust to changes to appearance and prevent distress It involves up to five 30-minute modules and patients can select how many and which modules to complete It is delivered by a psychological professional working in burns services
The primary aim of this study is to explore whether the ProACTive intervention is acceptable to burns patients A secondary objective is to gather preliminary data on the potential clinical effectiveness of the ProACTive intervention
A mixed-methods single-arm acceptability study will be conducted
ProACTive will be offered to burns patients aged 18 years or over meeting inclusion criteria and admitted to the burns service at Nottingham University Hospitals NHS Trust
Fifteen participants will be recruited to complete the intervention
The primary objective of exploring the acceptability of the ProACTive intervention will be measured by
Intervention update rate percentage of those invited to participate in the study
Descriptive data about reasons for not taking up the intervention if patients consent to participating in the study in this way
Patient feedback gathered through a semi-structured exit interview as soon as possible after the intervention ends within two weeks
Patient feedback gathered using a standardised self-report questionnaire to record helpful and hindering aspects of the intervention will be completed after every session completed
Descriptive data about how many and which of the sessions patients choose to complete and the spacing of sessions completed
The number of sessions completed during hospital admission and after hospital discharge and whether these were completed face to face or virtually
Descriptive data about participants preferences for receiving the post-session resources in paper or electronic format
The number of times participants viewed the post-session online videos containing audio-exercises
Descriptive data about reason for ending the intervention before all sessions have been completed
Template analysis King 2012 a form of thematic analysis Braun Clarke 2006 will be used to analyse patterns of meaning or themes within the transcripts of the interviews The Theoretical Framework of Acceptability TFA Sekhon et al 2017 will also be used to develop the interview schedule and the initial coding template
The secondary objective to gather preliminary data on the potential clinical effectiveness of the ProACTive intervention will be examined through scores on four standardised self-report measures of
Appearance concerns
Positive and negative affect
Psychological flexibility
Self-compassion
These measures will be completed before and after the intervention Wilcoxon tests will be used to compare pre- and post-intervention scores These exploratory analyses will indicate the extent to which appearance concerns decrease and psychological flexibility and self-compassion increase post-intervention compared to pre-intervention Differences between pre- and post-intervention means will also give an indication of the likely effect size of the intervention Cohens d
The outcome of the study will include knowledge about whether ProACTive is acceptable to burns patients when it is introduced during hospital admission and preliminary evidence about the effectiveness of ProACTive These outcomes will contribute to further intervention refinement and trial development
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None