Psychological Factors in Acne: A Focus on Psychological Trauma

NCT02314039 | Unknown

• 1 other identifier: 14-SS-1072
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Psychological trauma symptoms

  This will be measured using the ICD 11 Trauma Questionnaire (Knefel \& Lueger-Schuster, 2013) and will be used to answer all the research questions

  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.

Secondary Outcomes (6)

• Perceived severity of acne

  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.

• Clinical severity of acne

  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.

• Childhood traumatic history

  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.

• Adult traumatic history

  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.

• General psychological distress

  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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edinburgh Napier University: lead

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Zoe Chouliara, PhD

  Edinburgh Napier University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoe Chouliara, PhD

CONTACT

0131 455 3339; z.chouliara@napier.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Zoe Chouliara

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 10, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 11, 2014

Record last verified: 2014-12