NCT04445974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
454

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2021

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

June 16, 2020

Last Update Submit

August 17, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (17)

  • Change in dermatology specific quality of life

    Baseline to 1 week

  • Change in dermatology specific quality of life at follow up

    Baseline to 1 month

  • Chance in skin-specific shame

    Baseline to 1 week

  • Chance in skin-specific shame at follow up

    Baseline to 1 month

  • Change in appearance anxiety

    Baseline to 1 week

  • +12 more secondary outcomes

Other Outcomes (3)

  • Intervention evaluation

    1 week

  • Adherence

    Through study completion (on average 1 week)

  • Attrition

    Through study completion (on average 1 week)

Study Arms (2)

Expand Your Horizons: More than my skin

ACTIVE COMPARATOR

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.

Behavioral: Expand your horizons: More than my skin

Control writing activity

EXPERIMENTAL

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.

Behavioral: Creative writing activities

Interventions

'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.

Expand Your Horizons: More than my skin

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.

Control writing activity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, University of Sheffield

Sheffield, Choose Province, S1 2LT, United Kingdom

Location

Related Publications (7)

  • 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.

    PMID: 26280376BACKGROUND
  • 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.

    PMID: 25462882BACKGROUND
  • 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.

    PMID: 28822275BACKGROUND
  • 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.

    PMID: 8033378BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 23823485BACKGROUND
  • 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.

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

  • Paul G Overton, PhD

    University of Sheffield

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not be told whether they have been allocated to intervention or control condition until the end of the study. The control condition is a series of creative writing tasks, which are framed as an intervention within the introduction to the first task. This replicates previous RCTs of the same intervention in different populations (Alleva et al., 2015).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is an online single-blinded Randonmised Control Trial, which contains acceptability and feasibility components.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 24, 2020

Study Start

December 15, 2020

Primary Completion

August 5, 2021

Study Completion

August 5, 2021

Last Updated

August 18, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Participants will be asked as part of the consent form whether they would be willing for their anonymised data to be available to other researchers. Data won't be shared for participants who do not consent to this. Sharing of the remaining data will depend on sufficient participants consenting to this to not compromise anonymity or outcomes.

Locations