Testing a Body-functionality Intervention for Body Image in Individuals With Skin Conditions
NCT ID: NCT04445974
Last Updated: 2021-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
454 participants
INTERVENTIONAL
2020-12-15
2021-08-05
Brief Summary
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Detailed Description
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Recruitment from community sample, including: The University staff and student volunteers lists; Psychology undergraduate credit systems, Social media/forums; Charities; Research recruitment platforms, and a mailing lists.
Sample size:
An apriori power analysis, based on an ANCOVA, with a medium effect for the primary outcome (body appreciation) indicated a sample of 128 would be needed to achieve 80% power. Assuming an attrition rate of 50%, the total number of participants required will be 256.
In line with recommendations for evaluating interventions, we will include an internal pilot whereby we review the recruitment progress (completion) about 3 months into the trial and could then consider whether we need to make any minor or major adjustments to the recruitment strategy or study. If these substantial changes are needed, the pilot component will be written up and analysed separately to inform the next phase.
Procedure:
Time-point 1: Participants asked to read information sheet and provide consent. Participants will then be asked to complete the demographic measures and provide information on their skin condition(s). Participants will then complete baseline measures of trait body appreciation, body functionality, and, skin-specific quality of life, appearance anxiety with the order of these questionnaires counterbalanced. The online system will then randomly allocate individual meeting the exclusion criteria to either 'Expand Your Horizon' or an active control, at a ratio of 1:1. Participants will then be asked to complete the first writing activity and complete state measures
Time-point 2 (approximately 2 days later): Participants asked to complete the second writing exercise, and rate their state measures.
Time-point 3 (approximately 1 week later): Participants will be asked to complete the final writing task, before completing state measures and repeating the outcome measures given at baseline. Participants in both conditions will then be asked to provide feedback on the intervention.
Time-point 4 (One month later): Participants will be asked to repeat the outcome measures. Participants will then be shown the debrief screen and told which group they were in. Participants in the control condition will be offered a link to the intervention.
Analytic strategy:
The data will be initially assessed to check whether they meet the assumptions of the statistical tests used.
Descriptive statistics will then be used to describe the sample, and to summarise information on attrition at each point of the study and feedback on the intervention. Demographic and skin disease-history variables will be assessed for covariance using t-tests, ANOVAs and bivariate correlations as appropriate.
To assess whether randomisation of allocation to groups (intervention vs control) has been effective, t-tests and ANOVAs will be used, as appropriate, to compare demographics baseline measures.
T-tests will also be used to compare the levels of skin-specific appearance satisfaction, appearance satisfaction and body-functionality satisfaction between participants in both the intervention and control condition. This will include both intention-to-treat and completer analyses.
The effectiveness of the intervention will be tested using a series of between group ANCOVAs.
The number of participants showing reliable and clinical change on measures of anxiety and skin-specific quality of life will also be calculated for each group.
Change over time (Pre, post, one month follow up) for each group will be assessed using a repeated measures ANOVA. If any significant covariates, are identified ANCOVAs will be used instead.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Expand Your Horizons: More than my skin
Participants allocated to the intervention condition will be asked to follow the adapted instructions for 'Expand Your Horizon'. Participants will be asked to complete three 15 min writing exercises over approximately six days. Participants who complete the first exercise on Qualtrics will be sent links to and asked to complete the second and third writing exercises.
Expand your horizons: More than my skin
'Expand Your Horizon' is a self-help intervention which uses writing exercises to help individuals with poor body image practice focusing on their body-functionality rather than their physical appearance (Alleva et al., 2015). The materials for 'Expand Your Horizon' are freely available (Alleva et al., 2015), and permission has been granted to use and adapt the materials in this research. 'Expand Your Horizon' comprises of three 15 min writing exercises, typically completed over approximately six days. The intervention materials have been adapted for use with a population with skin diseases, and modified to use gender neutral language. Adaptions were made in consultation with experts by experience. The changes were reviewed and approved by the first author of the original intervention to ensure the materials were in keeping with the original intervention.
Control writing activity
Participants in the control condition will be asked to complete three 15 minute creative writing exercises online via Qualtucs over approximately six days. Participants completing the first writing exercise will be sent links to the second and third writing exercises.
Creative writing activities
In line with previous studies examining 'Expand Your Horizon' the active control condition will involve creative writing tasks (Alleva et al., 2015). Participants in the intervention condition will complete three 15 minute creative writing exercises, completed over six days.
Interventions
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Expand your horizons: More than my skin
'Expand Your Horizon' is a self-help intervention which uses writing exercises to help individuals with poor body image practice focusing on their body-functionality rather than their physical appearance (Alleva et al., 2015). The materials for 'Expand Your Horizon' are freely available (Alleva et al., 2015), and permission has been granted to use and adapt the materials in this research. 'Expand Your Horizon' comprises of three 15 min writing exercises, typically completed over approximately six days. The intervention materials have been adapted for use with a population with skin diseases, and modified to use gender neutral language. Adaptions were made in consultation with experts by experience. The changes were reviewed and approved by the first author of the original intervention to ensure the materials were in keeping with the original intervention.
Creative writing activities
In line with previous studies examining 'Expand Your Horizon' the active control condition will involve creative writing tasks (Alleva et al., 2015). Participants in the intervention condition will complete three 15 minute creative writing exercises, completed over six days.
Eligibility Criteria
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Inclusion Criteria
* 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
* Individuals who do not feel their body image is affected by having a dermatological condition.
18 Years
ALL
No
Sponsors
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University of Sheffield
OTHER
Responsible Party
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Principal Investigators
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Paul G Overton, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Sheffield
Locations
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Department of Psychology, University of Sheffield
Sheffield, Choose Province, United Kingdom
Countries
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References
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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.
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.
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.
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. doi: 10.1111/j.1365-2230.1994.tb01167.x.
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
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.
Adkins KV, Overton PG, Thompson AR. A brief online writing intervention improves positive body image in adults living with dermatological conditions. Front Med (Lausanne). 2022 Dec 21;9:1064012. doi: 10.3389/fmed.2022.1064012. eCollection 2022.
Other Identifiers
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165478
Identifier Type: -
Identifier Source: org_study_id
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