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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.
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProACTive intervention | Experimental | ProACTive intervention. Participants will choose how many, and which, modules to complete. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProACTive | Other | ProACTive intervention, a talking therapy utilising acceptance and commitment therapy (ACT) techniques. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham University Hospitals NHS Trust | Nottingham | NG7 2UH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11206302 | Background | 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. | |
| 21584907 | Background | Raes 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. |
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Open Science Framework. Final template of themes (qualitative data).
Acceptance of manuscript for publication.
The data will be made publicly available on the Open Science Framework upon acceptance of the manuscript for publication.
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000097813 | Coping Skills |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 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. | 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. | 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. | As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending |
| 3397865 | Background | Watson 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. |
| 3191302 | Background | Llewelyn 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. |
| Background | Francis, 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. |