NCT04445974

Testing a Body-functionality Intervention for Body Image in Individuals With Skin Conditions

Can a Brief Body-functionality Writing Intervention Improve Body Image in Individuals Living With a Skin Condition? A Randomised Control Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 454 (actual)
• Sponsor: University of Sheffield · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

'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.

Detailed description

Method of sampling/recruitment: 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

• Body Image
• Psychological Distress
• Dermatologic Disease
• Quality of Life

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2020-12-15
• Primary completion: 2021-08-05
• Completion: 2021-08-05
• First posted: 2020-06-24
• Last updated: 2021-08-18

Locations

1 site across 1 country: United Kingdom