Clinical trial NCT04445974: Testing a Body-functionality Intervention for Body Image in Individuals With Skin Conditions
Official title: Can a Brief Body-functionality Writing Intervention Improve Body Image in Individuals Living With a Skin Condition? A Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Image
Psychological Distress
Dermatologic Disease
Quality of Life
Lead sponsor: University of Sheffield
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 454
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is an online single-blinded Randonmised Control Trial, which contains acceptability and feasibility components.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in body appreciation
timeFrame: Baseline to 1 week
measure: Change in body functionality appreciation
timeFrame: Baseline to 1 week
Secondary outcomes:
measure: Change in dermatology specific quality of life
timeFrame: Baseline to 1 week
measure: Change in dermatology specific quality of life at follow up
timeFrame: Baseline to 1 month
measure: Chance in skin-specific shame
timeFrame: Baseline to 1 week
measure: Chance in skin-specific shame at follow up
timeFrame: Baseline to 1 month
measure: Change in appearance anxiety
timeFrame: Baseline to 1 week
measure: Change in appearance anxiety at follow up
timeFrame: Baseline to 1 month
measure: State appearance satisfaction
timeFrame: Day 1
measure: State appearance satisfaction
timeFrame: Day 3 (approximately)
measure: State appearance satisfaction
timeFrame: 1 week
measure: State skin appearance satisfaction
timeFrame: Day 1
measure: State skin appearance satisfaction
timeFrame: Day 3 (approximately)
measure: State skin appearance satisfaction
timeFrame: 1 week
measure: State functionality satisfaction
timeFrame: Day 1
measure: State functionality satisfaction
timeFrame: Day 3 (approximately)
measure: State functionality satisfaction
timeFrame: 1 week
measure: Change in body appreciation at follow up
timeFrame: Baseline to 1 month
measure: Change in body functionality appreciation at follow up
timeFrame: Baseline to 1 month
Other outcomes:
measure: Intervention evaluation
timeFrame: 1 week
measure: Adherence
timeFrame: Through study completion (on average 1 week)
measure: Attrition
timeFrame: Through study completion (on average 1 week)
Locations:
city: Sheffield
country: United Kingdom
facility: Department of Psychology, University of Sheffield
state: Choose Province
Study officials:
affiliation: University of Sheffield
name: Paul G Overton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.
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. doi: 10.1111/j.1365-2230.1994.tb01167.x.
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
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.