Psoriasis, psoriatic arthritis and mental health; version 1
Research type
Research Study
Full title
Psoriasis, psoriatic arthritis and mental health
IRAS ID
256264
Contact name
Elise Kleyn
Contact email
Sponsor organisation
University of Manchester
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 11 months, 29 days
Research summary
Psoriasis is skin disease which affects almost 2% of people in the United Kingdom. It is known to affect more than the skin, eg. joints and overall wellbeing.\nDepression, the leading cause of disability worldwide, is found more often than would be expected in psoriasis. Patients may experience significant distress, including suicidal thoughts. Depression may also be found more often in patients with both skin and joint disease. \n \nA negative self image has been linked to both depression and psoriasis. Furthermore, there is increasing scientific information linking depression to inflammatory pathways, which could also underlie psoriasis. \n\nThe focus of the study is to investigate and compare the proportions of patients with moderate to severe psoriasis and with both psoriasis and psoriatic arthritis suffering from depression in hospital (tertiary referral) clinics. \nIn order to do this, questionnaires will be given to two patient groups and one control group. The participants will be followed-up in 12 months time. The patients will be recruited in Salford Royal NHS Foundation Trust. The healthy volunteers will be recruited through a volunteer database and via advertisement, in the University of Manchester and online. The study is funded by the Psoriasis Association. \n\nThe findings will move forward our understanding of the extent of the difficulties/burden that mental health issues (depression, suicidality) might cause for patients from the 2 groups we are studying. Importantly, it could also give insights into the impact of living with joint disease (arthritis) on patients’ mental health/wellbeing. \n\nUnderstanding the relationship of mood disorders with psoriasis and psoriatic arthritis is crucial in order to ensure appropriate therapies for these complex patients. Targeted therapies could reduce distress and psychiatric mortality, improve quality of life and influence disease course. This is important, particularly given reports of a purported association between psoriasis therapies and suicidality risk. [COVID 19 amendment 23/04/2020] Covid-19 amendments: 1. Increased sample size\n2. Addition of secondary study objectives: (i) to test whether the depression and anxiety burden differs before the coronavirus pandemic, during the coronavirus quarantine measures and after the coronavirus quarantine measures in the study groups and (ii) to investigate prevalence of post-traumatic stress disorder symptoms in the study groups after the end of coronavirus quarantine measures.\n3. Participants will be invited by phone\n4. Addition of a brief questionnaire for all groups, which will collect data about pandemic-related social\nchanges and, for patients, also treatment changes (questionnaire attached).\n5. Conduct questionnaires by telephone rather than by post\n\nPermanent amendments:\n\n1. We propose to differentiate between current and lifetime mental health treatment and current and lifetime drug abuse in the Medical History form questions for all groups (as it is also likely to be a current dysfunctional coping strategy to the crisis for some people).\n2. We would also like to currently extend online advertisement of the study for healthy volunteers to the following websites: Gumtree, Callforparticipants, Psychological Research on the Net and Research Gate websites; as well as extend physical advertisement for healthy volunteers to placing posters/flyers in local GP surgeries, after the end of the quarantine. The advertisements used across all websites will be the ones stated in the amended UoM Online Advertisement document (Version 2 enclosed). COVID 19 amendment 28/04/2020 1. Increased sample size 2. Addition of secondary study objectives: (i) to test whether the depression and anxiety burden differs before the coronavirus pandemic, during the coronavirus quarantine measures and after the coronavirus quarantine measures in the study groups and (ii) to investigate prevalence of post-traumatic stress disorder symptoms in the study groups after the end of coronavirus quarantine measures.\n3. Participants will be invited by phone\n4. Addition of a brief questionnaire for all groups, which will collect data about pandemic-related social\nchanges and, for patients, also treatment changes (questionnaire attached).\n5. Conduct questionnaires by telephone rather than by post\n\nPermanent amendments:\n\n1. We propose to differentiate between current and lifetime mental health treatment and current and lifetime drug abuse in the Medical History form questions for all groups (as it is also likely to be a current dysfunctional coping strategy to the crisis for some people).\n2. We would also like to currently extend online advertisement of the study for healthy volunteers to the following websites: Gumtree, Callforparticipants, Psychological Research on the Net and Research Gate websites; as well as extend physical advertisement for healthy volunteers to placing posters/flyers in local GP surgeries, after the end of the quarantine. The advertisements used across all websites will be the ones stated in the amended UoM Online Advertisement document.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
19/NW/0351
Date of REC Opinion
30 Jul 2019
REC opinion
Further Information Favourable Opinion