Burn InjuriesNCT06377709
A Mixed-methods Acceptability Study of ProACTive to Help Burns Patients Adjust to Changes to Appearance
A study testing ProACTive in people with Burn Injuries and Burns, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Injuries, Burns, Emotional Distress
- What is being tested?
- ProACTive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jun 2024to 5 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 years and over) admitted as inpatients to the burns service with an acute burn injury
Who cannot join
- Patients already receiving psychological input from the burns clinical psychology service for appearance related concerns, over and above supportive listening
- Patients admitted as inpatients to the burns service for reconstructive surgery, for a historical burn injury
- Patients who are too physically unwell to participate
- Patients deemed too psychologically unwell or in a mental health crisis by the usual clinical care team (for example, patients who sustained their burn injury due to a suicide attempt or self-harm, are currently having suicidal thoughts, or those with psychosis)
- Patients who are not fluent in the English language in order to participate
- Patients with a known cognitive impairment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
About this study
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
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.
Read the 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 (Cohen's 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.
- Conditions
- Burn Injuries, Burns, Emotional Distress, Adjustment
- Being tested
- ProACTive
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProACTiveOther
ProACTive intervention, a talking therapy utilising acceptance and commitment therapy (ACT) techniques.
| Study group | Role | What they receive |
|---|---|---|
| ProACTive intervention | Experimental | ProACTive intervention. Participants will choose how many, and which, modules to complete. Receives: Other: ProACTive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Esteem Scale for Adolescents and Adults - Appearance subscale (BESAA-A)
A 10-item self-report questionnaire that measures appearance concerns/body esteem. Responses to each item fall on a scale between 0 and 4. The total mean score is used, falling between 0 and 4. Higher scores indicate higher appearance esteem (i.e. lower appearance concerns).
Measured: As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending
Secondary outcomes (4)
Positive and Negative Affect Schedule (PANAS-GEN)
A 20-item standardised measure of positive and negative affect. Responses to items are scored between 1 and 5. Ten items relate to positive affect and 10 items relate to negative affect. Scores range from 10 to 50 for both sets of items. For the total positive score, a higher score indicates more positive affect. For the total negative score, a lower score indicates less negative affect. The total score is calculated by the sum of the 10 positive items and then the 10 negative items.
Measured: As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending
Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT)
A 23-item self-report questionnaire that measures psychological flexibility. Responses to each item fall on a scale between 0 and 6. The total score is used, ranging from 0 to 138. Three subscale scores can also be generated. Higher scores indicate greater psychological flexibility.
Measured: As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending
Self-Compassion Scale - Short Form (SCS-SF)
A 12-item self-report questionnaire that measures self-compassion. Responses to items fall on a scale between 1 and 5. The total mean score is used, with values ranging between 1 and 5. Higher scores indicate higher self-compassion.
Measured: As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending
Helpful Aspects of Therapy Form (HAT)
A seven-item self-report questionnaire that gathers mainly qualitative data about helpful and hindering aspects of therapy sessions.
Measured: As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start13 Jun 2024
- Primary completion5 Mar 2025
- Study completion5 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Burn InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377709
- Sponsor's protocol ID
- 24CP001
- Status last verified
- Jun 2025
- First submitted
- 17 Apr 2024
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Open Science Framework. Final template of themes (qualitative data).
Publications
Mendelson BK, Mendelson MJ, White DR. Body-esteem scale for adolescents and adults. J Pers Assess. 2001 Feb;76(1):90-106. doi: 10.1207/S15327752JPA7601_6.
PubMed 11206302Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
PubMed 21584907Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
PubMed 3397865Llewelyn SP. Psychological therapy as viewed by clients and therapists. Br J Clin Psychol. 1988 Sep;27(3):223-37. doi: 10.1111/j.2044-8260.1988.tb00779.x.
PubMed 3191302Francis, A. W., Dawson, D. L., & Golijani-Moghaddam, N. (2016). The development and validation of the Comprehensive Assessment of Acceptance and Commitment Therapy processes (CompACT). Journal of Contextual Behavioral Science, 5(3), 134-145.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06377709
- Acronym / sponsor ID
- 24CP001
- Conditions
- Burn Injuries, Burns, Emotional Distress, Adjustment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (Cohen's 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ProACTive intervention | Experimental | Other: ProACTiveProACTive intervention. Participants will choose how many, and which, modules to complete. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (18 years and over) admitted as inpatients to the burns service with an acute burn injury
Key exclusion criteria (6 listed)
- Patients already receiving psychological input from the burns clinical psychology service for appearance related concerns, over and above supportive listening
- Patients admitted as inpatients to the burns service for reconstructive surgery, for a historical burn injury
- Patients who are too physically unwell to participate
- Patients deemed too psychologically unwell or in a mental health crisis by the usual clinical care team (for example, patients who sustained their burn injury due to a suicide attempt or self-harm, are currently having suicidal thoughts, or those with psychosis)
- Patients who are not fluent in the English language in order to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProACTiveProACTive intervention, a talking therapy utilising acceptance and commitment therapy (ACT) techniques. | Other | ProACTive intervention |
Primary outcome
Body Esteem Scale for Adolescents and Adults - Appearance subscale (BESAA-A)
Time frame: As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending
A 10-item self-report questionnaire that measures appearance concerns/body esteem. Responses to each item fall on a scale between 0 and 4. The total mean score is used, falling between 0 and 4. Higher scores indicate higher appearance esteem (i.e. lower appearance concerns).
4 secondary outcomes
Positive and Negative Affect Schedule (PANAS-GEN)
Time frame: As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending
Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT)
Time frame: As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending
Self-Compassion Scale - Short Form (SCS-SF)
Time frame: As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending
Helpful Aspects of Therapy Form (HAT)
Time frame: As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Background: PubMed 11206302Mendelson BK, Mendelson MJ, White DR. Body-esteem scale for adolescents and adults. J Pers Assess. 2001 Feb;76(1):90-106. doi: 10.1207/S15327752JPA7601_6.
- Background: PubMed 21584907Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
- Background: PubMed 3397865Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Background: PubMed 3191302Llewelyn SP. Psychological therapy as viewed by clients and therapists. Br J Clin Psychol. 1988 Sep;27(3):223-37. doi: 10.1111/j.2044-8260.1988.tb00779.x.
- BackgroundFrancis, A. W., Dawson, D. L., & Golijani-Moghaddam, N. (2016). The development and validation of the Comprehensive Assessment of Acceptance and Commitment Therapy processes (CompACT). Journal of Contextual Behavioral Science, 5(3), 134-145.
- Individual participant dataSharing planned: Yes. Open Science Framework. Final template of themes (qualitative data).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProACTive in people with Burn Injuries and Burns, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Esteem Scale for Adolescents and Adults - Appearance subscale (BESAA-A) (time frame: As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06377709, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.