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Psychological Factors in Acne: A Focus on Psychological Trauma

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ClinicalTrials.gov Identifier: NCT02314039
Recruitment Status : Unknown
Verified December 2014 by Dr Zoe Chouliara, Edinburgh Napier University.
Recruitment status was:  Not yet recruiting
First Posted : December 10, 2014
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
Dr Zoe Chouliara, Edinburgh Napier University

Brief Summary:
This cross sectional questionnaire based study will aim at exploring psychological factors at play in the experience of acne, and their association with perceived and clinical severity. We will focus in particular on the role of psychological trauma in the patients with acne and their wellness. This project is being undertaken as part of a wider developing initiative in the Dermatology Department within NHS Tayside, which aims at identifying and consequently addressing the psychological needs of their patients. Participants will be consecutive patients with acne aged at least 18 years old, seen in the outpatient clinics of the Dermatology Department in NHS Tayside. Potential participants will be informed about the research by their clinician during an outpatients appointment and if interested, given an information sheet and consent form to review. Verbal consent will be sought by the clinician to give the potential participant's contact details to the Chief Investigator (CI)/Research Assistant (RA). If agreeable, the CI/RA will contact the potential participant after at least 24 hours to arrange a mutually agreed time for meeting. If the potential participant are still keen to participate and has read the information sheet, fit our inclusion criteria, are not deemed to be distressed by their attending clinician and want to take part, they will be included. Participants will complete a number of standardised questionnaires and a demographics information sheet in the outpatients' clinic with the CI/RA present. The questionnaires include questions on psychological trauma history and symptomatology, general psychological distress, appearance related distress and perceived severity of condition. Clinical severity of their acne will be obtained from patient files after questionnaire completion by NHS staff. Participants will also be given a debrief letter and additional forms of support and information to take home with them. Participants will not be contacted for follow-up.

Condition or disease
Acne Vulgaris

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Psychological Factors in Acne: A Focus on Psychological Trauma
Study Start Date : January 2015
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Psychological trauma symptoms [ Time Frame: This outcome will be measured once during the 6 month recruitment period. All outcomes will be measured at the same timepoint. This timepoint is expected to last no longer than 2 hours. ]
    This will be measured using the ICD 11 Trauma Questionnaire (Knefel & Lueger-Schuster, 2013) and will be used to answer all the research questions


Secondary Outcome Measures :
  1. Perceived severity of acne [ Time Frame: This outcome will be measured once during the 6 month recruitment period. All outcomes will be measured at the same timepoint. This timepoint is expected to last no longer than 2 hours. ]
    This will be measured by the Cardiff Acne Disability Index (Motley & Finlay, 1992) and will be used to answer research questions 1, 3 and 4.

  2. Clinical severity of acne [ Time Frame: This outcome will be measured once during the 6 month recruitment period. All outcomes will be measured at the same timepoint. This timepoint is expected to last no longer than 2 hours. ]
    This is measured as a part of routine assessment in all acne patients attending dermatology departments. The information can be found in patients' files and is recorded in the format 'mild, moderate or severe acne'. This information will be used to answered research questions 1, 3 and 4.

  3. Childhood traumatic history [ Time Frame: This outcome will be measured once during the 6 month recruitment period. All outcomes will be measured at the same timepoint. This timepoint is expected to last no longer than 2 hours. ]
    This will be measured using the Childhood Trauma Questionnaire (Bernstein et al., 1994) and will be used to answer research questions 3 and 4.

  4. Adult traumatic history [ Time Frame: This outcome will be measured once during the 6 month recruitment period. All outcomes will be measured at the same timepoint. This timepoint is expected to last no longer than 2 hours. ]
    This will be measured using Life Events Checklist (Blake et al, 1995) and will be used to answer research questions 3 and 4.

  5. General psychological distress [ Time Frame: This outcome will be measured once during the 6 month recruitment period. All outcomes will be measured at the same timepoint. This timepoint is expected to last no longer than 2 hours. ]
    This will be measured using the DASS 21(Lovibond & Lovibond, 1995) and will be used to answer research question 4.

  6. Appearance-related distress [ Time Frame: This outcome will be measured once during the 6 month recruitment period. All outcomes will be measured at the same timepoint. This timepoint is expected to last no longer than 2 hours. ]
    This will be measured using the Derriford Appearance Scale (DAS) (Carr et al., 2000) and will be used to answer research question 4.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population sample will be recruited from NHS Tayside dermatology departments, i.e. Ninewells, Stracathro, and Perth Hospital.
Criteria

Inclusion Criteria:

  • Patients in NHS Tayside in one of the three participating dermatology outpatient departments
  • Aged 18 years old or older
  • Attending the clinic for acne
  • Fluent in speaking and understanding English
  • Deemed by qualified clinical staff as routine practice, as able to give informed consent form

Exclusion Criteria:

  • Individuals who have a learning disability or organic disorder that would impair their ability to provide informed consent or understand and respond to the questionnaires
  • Under the influence of illicit substances at the time of administration of the questionnaires
  • In a distressing state, as judged by clinical staff and/or the investigators.

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): NCT02314039


Contacts
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Contact: Zoe Chouliara, PhD 0131 455 3339 ext 3339 z.chouliara@napier.ac.uk

Sponsors and Collaborators
Edinburgh Napier University
Investigators
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Principal Investigator: Zoe Chouliara, PhD Edinburgh Napier University

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Responsible Party: Dr Zoe Chouliara, Edinburgh Napier University
ClinicalTrials.gov Identifier: NCT02314039     History of Changes
Other Study ID Numbers: 14-SS-1072
First Posted: December 10, 2014    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
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Acne Vulgaris
Psychological Trauma
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders