Clinical Trial: Psychological Factors in Acne: A Focus on Psychological Trauma
Study Status: Enrolling by invitation
Recruit Status: Unknown status
Study Type: Observational
Official Title: Psychological Factors in Acne: A Focus on Psychological Trauma
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-
Detailed Summary:
The research questions are as follows:
- What is the association between psychological trauma symptoms, and perceived/clinical severity of the condition?
- What are the levels of psychological trauma symptoms exhibited in patients with acne?
- What are the associations between traumatic history (in childhood and adulthood), current traumatic symptoms exhibited and perceived/clinical severity?
- What is the association between psychological trauma symptomatology, trauma history, general psychological distress, appearance-related distress and perceived/clinical severity?
Design: A quantitative cross--sectional design will be used. Five self-report, standardised questionnaires will be completed by participants and assisted by the Chief Investigator (CI) or the Research Assistant (RA) to the study. The questionnaires contains measures on:
psychological trauma history; perceived severity of acne; general appearance--related distress; and depression, stress and anxiety.
Basic demographics will be collected by asking participants to also complete a Demographics Information sheet (measuring age, gender, time since diagnosis etc.). Information on objective severity of acne will be provided by staff (e.g. named specialist nurse of consultant dermatologist for each clinical site). Information on objective severity is routinely measured in dermatology clinical practice and such information will be available in file for each patient.
Participants: The population sample will be recruited from NHS Tayside dermatology departments, i.e. Ninewel
Sponsor: Edinburgh Napier University
Current Primary Outcome: 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. ]
Original Primary Outcome: Psychological trauma symptoms [ Time Frame: Single point in time ]
Current Secondary Outcome:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Original Secondary Outcome:
- Perceived severity of acne [ Time Frame: Single point in time ]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.
- Clinical severity of acne [ Time Frame: Single point in time ]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.
- Childhood traumatic history [ Time Frame: Single point in time ]This will be measured using the Childhood Trauma Questionnaire (Bernstein et al., 1994) and will be used to answer research questions 3 and 4.
- Adult traumatic history [ Time Frame: Single point in time ]This will be measured using Life Events Checklist (Blake et al, 1995) and will be used to answer research questions 3 and 4.
- General psychological distress [ Time Frame: Single point in time ]This will be measured using the DASS 21(Lovibond & Lovibond, 1995) and will be used to answer research question 4.
- Appearance-related distress [ Time Frame: Single point in time ]This will be measured using the Derriford Appearance Scale (DAS) (Carr et al., 2000) and will be used to answer research question 4.
Information By: Edinburgh Napier University
Dates:
Date Received: December 8, 2014
Date Started: January 2015
Date Completion: June 2015
Last Updated: December 9, 2014
Last Verified: December 2014
