Quality of Life Clinical Trial
Official title:
Can a Brief Body-functionality Writing Intervention Improve Body Image in Individuals Living With a Skin Condition? A Randomised Control Trial
NCT number | NCT04445974 |
Other study ID # | 165478 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 15, 2020 |
Est. completion date | August 5, 2021 |
Verified date | August 2021 |
Source | University of Sheffield |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
'Expand Your Horizons', a self-help writing intervention that seeks to train individuals to focus on what their body can do (functionality) rather than what it looks like (appearance), has produced promising results in improving body image. However, it has not been adapted and trialled in populations with conditions affecting skin appearance. This research therefore seeks to evaluate the potential for 'Expand Your Horizons' to (1) improve body image, as measured by body and functionality appreciation; and (2) improve skin-specific outcome, as measure by skin-shame, dermatology and quality of life, in a population with dermatological conditions, using a Randomised Control Trail.
Status | Completed |
Enrollment | 454 |
Est. completion date | August 5, 2021 |
Est. primary completion date | August 5, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Individuals with dermatological condition (including conditions that affect the skin, hair and/or nails). This includes, but is not limited to, acne, eczema, alopecia, psoriasis, vitiligo, rosacea, dermatitis, hyperpigmentation, hidradenitis suppurativa (HS), hyperhidrosis, hirsutism, neurofibromatosis, onychomycosis, melasma, cysts, herpes, ichthyosis, and lichen sclerosus. - Individuals self-reporting that their body image is affected by their skin condition. - Sufficient English to complete the measures and writing exercises - Access to the internet. Exclusion Criteria: - As the focus of this research is on skin disease, individuals living with visible differences as a consequence of trauma (e.g. scarring from burns or scarring from traumatic injury) are not eligible to participate in this study. - Individuals who do not feel their body image is affected by having a dermatological condition. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Department of Psychology, University of Sheffield | Sheffield | Choose Province |
Lead Sponsor | Collaborator |
---|---|
University of Sheffield |
United Kingdom,
Alleva JM, Martijn C, Van Breukelen GJ, Jansen A, Karos K. Expand Your Horizon: A programme that improves body image and reduces self-objectification by training women to focus on body functionality. Body Image. 2015 Sep;15:81-9. doi: 10.1016/j.bodyim.2015.07.001. Epub 2015 Aug 14. — View Citation
Alleva JM, Tylka TL, Kroon Van Diest AM. The Functionality Appreciation Scale (FAS): Development and psychometric evaluation in U.S. community women and men. Body Image. 2017 Dec;23:28-44. doi: 10.1016/j.bodyim.2017.07.008. Epub 2017 Aug 17. — View Citation
Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. — View Citation
Scott, C. (2004). Understanding psychodermatological distress: constructing a skin shame scale (Doctoral dissertation, University of Sheffield, UK). Retrieved from http://etheses.whiterose.ac.uk/14863/1/412462.pdf
Tylka TL, Wood-Barcalow NL. The Body Appreciation Scale-2: item refinement and psychometric evaluation. Body Image. 2015 Jan;12:53-67. doi: 10.1016/j.bodyim.2014.09.006. Epub 2014 Oct 21. — View Citation
Veale D, Eshkevari E, Kanakam N, Ellison N, Costa A, Werner T. The Appearance Anxiety Inventory: validation of a process measure in the treatment of body dysmorphic disorder. Behav Cogn Psychother. 2014 Sep;42(5):605-16. doi: 10.1017/S1352465813000556. Epub 2013 Jul 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Intervention evaluation | Participants in the functionality intervention will be asked to complete a series of questions about their experience of the intervention, and given the option to add any further comments in a free text box. | 1 week | |
Other | Adherence | Adherence will be assessed by reviewing the content of participants writing and time-spent on the exercises and word count. Participant entries will also be rated, on a three-point scale, whether the content of participants writing conforms to the given instructions; if there is no relevant content, it will be scored 0, if instructions are partially followed, it will score 1, and if instruction are fully followed it will score a 2.
to identify inappropriate responses. Previous studies evaluating the intervention have reported minimal information about how adherence was assessed. |
Through study completion (on average 1 week) | |
Other | Attrition | The number of participants that drop out across the study | Through study completion (on average 1 week) | |
Primary | Change in body appreciation | The Body Appreciation Scale 2 (BAS-2, Tylka & Wood-Barcalow, 2015) will be used to measure body appreciation and contains 10 items, and will be used to measure trait levels of body appreciation. Each item is rated on a scale of 1 (never) to 5 (always). The average score is calculated by adding each item and divided by 10, and can range between 1 and 5 with higher numbers indicating higher levels of body appreciation. | Baseline to 1 week | |
Primary | Change in body functionality appreciation | The Functionality Appreciation Scale (FAS: Alleva, Tylka, & Van Diest, 2017) will be used to measure body functionality appreciation. The FAS comprises of seven questions, and will be used to assess participants' trait levels of appreciation for their bodies' functionality (Appendix L). Each item is rated on a scale from 1 (strongly disagree) to 5 (strongly agree). The average score is calculated by adding each item and dividing by 7, and can range between 1 and 5 with higher numbers indicating higher levels of function appreciation. | Baseline to 1 week | |
Secondary | Change in dermatology specific quality of life | The Dermatology Quality of Life Index (DLQI: Finlay & Khan, 1994) will be used to measure the impact of skin-conditions on participants' quality of life (Appendix M). The DLQI contains 10 questions scored from 0 (not at all/not relevant) to 3 (very much). Total scores range from 0 to 30, with lower scores indicating greater skin-specific quality of life. | Baseline to 1 week | |
Secondary | Change in dermatology specific quality of life at follow up | The Dermatology Quality of Life Index (DLQI: Finlay & Khan, 1994) will be used to measure the impact of skin-conditions on participants' quality of life (Appendix M). The DLQI contains 10 questions scored from 0 (not at all/not relevant) to 3 (very much). Total scores range from 0 to 30, with lower scores indicating greater skin-specific quality of life. | Baseline to 1 month | |
Secondary | Chance in skin-specific shame | The Skin Shame Scale (SSS: Scott, 2004) will be used to measure levels of skin-specific shame. The SSS contains 24 items, which are rated on a scale from 1 (never) to 5 (always). Total scores can range from 24 to 120, with higher score indicating greater levels of shame. | Baseline to 1 week | |
Secondary | Chance in skin-specific shame at follow up | The Skin Shame Scale (SSS: Scott, 2004) will be used to measure levels of skin-specific shame. The SSS contains 24 items, which are rated on a scale from 1 (never) to 5 (always). Total scores can range from 24 to 120, with higher score indicating greater levels of shame. | Baseline to 1 month | |
Secondary | Change in appearance anxiety | The Appearance Anxiety Index (AAI: Veale et al., 2014) will be used to measure appearance anxiety. The AAI contains 10 questions focused on cognitive and behavioural components of appearance-related anxiety, including avoidance and threat monitoring. Each item is scored on a five point Likert scale from 0 (not at all) to 4 (all the time). Total scores can range from 0 to 40, with higher scores indicating a greater level of appearance-related anxiety. | Baseline to 1 week | |
Secondary | Change in appearance anxiety at follow up | The Appearance Anxiety Index (AAI: Veale et al., 2014) will be used to measure appearance anxiety. The AAI contains 10 questions focused on cognitive and behavioural components of appearance-related anxiety, including avoidance and threat monitoring. Each item is scored on a five point Likert scale from 0 (not at all) to 4 (all the time). Total scores can range from 0 to 40, with higher scores indicating a greater level of appearance-related anxiety. | Baseline to 1 month | |
Secondary | State appearance satisfaction | After writing exercise 1, participants will also be asked to rate their state satisfaction with their appearance on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied). | Day 1 | |
Secondary | State appearance satisfaction | After writing exercise 2, participants will also be asked to rate their state satisfaction with their appearance on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied). | Day 3 (approximately) | |
Secondary | State appearance satisfaction | After writing exercise 3, participants will also be asked to rate their state satisfaction with their appearance on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied). | 1 week | |
Secondary | State skin appearance satisfaction | After writing task 1, participants will also be asked to rate their satisfaction with their state skin appearance on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied). | Day 1 | |
Secondary | State skin appearance satisfaction | After writing task 2, participants will also be asked to rate their satisfaction with their state skin appearance on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied). | Day 3 (approximately) | |
Secondary | State skin appearance satisfaction | After writing task 3, participants will also be asked to rate their satisfaction with their state skin appearance on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied). | 1 week | |
Secondary | State functionality satisfaction | After writing task 1, participants will also be asked to rate their state satisfaction with their body functionality on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied). | Day 1 | |
Secondary | State functionality satisfaction | After writing task 2, participants will also be asked to rate their state satisfaction with their body functionality on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied). | Day 3 (approximately) | |
Secondary | State functionality satisfaction | After writing task 3, participants will also be asked to rate their state satisfaction with their body functionality on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied). | 1 week | |
Secondary | Change in body appreciation at follow up | The Body Appreciation Scale 2 (BAS-2, Tylka & Wood-Barcalow, 2015) will be used to measure body appreciation and contains 10 items, and will be used to measure trait levels of body appreciation. Each item is rated on a scale of 1 (never) to 5 (always). The average score is calculated by adding each item and divided by 10, and can range between 1 and 5 with higher numbers indicating higher levels of body appreciation. | Baseline to 1 month | |
Secondary | Change in body functionality appreciation at follow up | The Functionality Appreciation Scale (FAS: Alleva, Tylka, & Van Diest, 2017) will be used to measure body functionality appreciation. The FAS comprises of seven questions, and will be used to assess participants' trait levels of appreciation for their bodies' functionality (Appendix L). Each item is rated on a scale from 1 (strongly disagree) to 5 (strongly agree). The average score is calculated by adding each item and dividing by 7, and can range between 1 and 5 with higher numbers indicating higher levels of function appreciation. | Baseline to 1 month |
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