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

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ClinicalTrials.gov Identifier: NCT04445974
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
University of Sheffield

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.

Condition or disease Intervention/treatment Phase
Body Image Psychological Distress Dermatologic Disease Quality of Life Behavioral: Expand your horizons: More than my skin Behavioral: Creative writing activities Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is an online single-blinded Randonmised Control Trial, which contains acceptability and feasibility components.
Masking: Single (Participant)
Masking Description: 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).
Primary Purpose: Treatment
Official Title: Can a Brief Body-functionality Writing Intervention Improve Body Image in Individuals Living With a Skin Condition? A Randomised Control Trial
Actual Study Start Date : December 15, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : September 24, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions

Arm Intervention/treatment
Active Comparator: 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.
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.

Experimental: 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.
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.




Primary Outcome Measures :
  1. Change in body appreciation [ Time Frame: Baseline to 1 week ]
    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.

  2. Change in body functionality appreciation [ Time Frame: Baseline to 1 week ]
    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.


Secondary Outcome Measures :
  1. Change in dermatology specific quality of life [ Time Frame: Baseline to 1 week ]
    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.

  2. Change in dermatology specific quality of life at follow up [ Time Frame: Baseline to 1 month ]
    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.

  3. Chance in skin-specific shame [ Time Frame: Baseline to 1 week ]
    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.

  4. Chance in skin-specific shame at follow up [ Time Frame: Baseline to 1 month ]
    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.

  5. Change in appearance anxiety [ Time Frame: Baseline to 1 week ]
    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.

  6. Change in appearance anxiety at follow up [ Time Frame: Baseline to 1 month ]
    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.

  7. State appearance satisfaction [ Time Frame: Day 1 ]
    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).

  8. State appearance satisfaction [ Time Frame: Day 3 (approximately) ]
    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).

  9. State appearance satisfaction [ Time Frame: 1 week ]
    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).

  10. State skin appearance satisfaction [ Time Frame: Day 1 ]
    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).

  11. State skin appearance satisfaction [ Time Frame: Day 3 (approximately) ]
    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).

  12. State skin appearance satisfaction [ Time Frame: 1 week ]
    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).

  13. State functionality satisfaction [ Time Frame: Day 1 ]
    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).

  14. State functionality satisfaction [ Time Frame: Day 3 (approximately) ]
    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).

  15. State functionality satisfaction [ Time Frame: 1 week ]
    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).

  16. Change in body appreciation at follow up [ Time Frame: Baseline to 1 month ]
    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.

  17. Change in body functionality appreciation at follow up [ Time Frame: Baseline to 1 month ]
    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.


Other Outcome Measures:
  1. Intervention evaluation [ Time Frame: 1 week ]
    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.

  2. Adherence [ Time Frame: Through study completion (on average 1 week) ]

    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.


  3. Attrition [ Time Frame: Through study completion (on average 1 week) ]
    The number of participants that drop out across the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445974


Contacts
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Contact: Kate V Adkins, PhD (+44) 114 222 6650 k.adkins@sheffield.ac.uk

Locations
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United Kingdom
Department of Psychology, University of Sheffield Recruiting
Sheffield, Choose Province, United Kingdom, S1 2LT
Contact: Kate V Adkins, PhD       kadkins2@sheffield.ac.uk   
Sponsors and Collaborators
University of Sheffield
Investigators
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Principal Investigator: Paul G Overton, PhD University of Sheffield
Publications:
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Responsible Party: University of Sheffield
ClinicalTrials.gov Identifier: NCT04445974    
Other Study ID Numbers: 165478
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Skin Diseases