跳至主要内容
临床试验/NCT02314039
NCT02314039Unknown不适用

Psychological Factors in Acne: A Focus on Psychological Trauma

Edinburgh Napier University0 个研究点目标入组 180 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
180
主要终点
Psychological trauma symptoms

研究概览

简要总结

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.

详细描述

The research questions are as follows:

  1. What is the association between psychological trauma symptoms, and perceived/clinical severity of the condition?
  2. What are the levels of psychological trauma symptoms exhibited in patients with acne?
  3. What are the associations between traumatic history (in childhood and adulthood), current traumatic symptoms exhibited and perceived/clinical severity?
  4. 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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Psychological trauma symptoms

时间窗: 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

次要结局

  • 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.)
  • Appearance-related 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.)
  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Zoe Chouliara

Dr Zoe Chouliara

Edinburgh Napier University

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