The ethics approval document is included as Appendix B in the thesis.Trish, did you ever get the trial documents you asked for a while ago?
The ethics documents include this:
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Background and justification
Many people suffer from conditions such as chronic fatigue syndrome, irritable bowel syndrome and fibromyalgia that have no simple medical explanation. Together, they are known as ‘Functional Somatic Disorders’ or FSD, and a combination of biological, social and psychological factors are thought to be important in understanding how they occur. These conditions are common, with up to a third of all consultations in primary care including FSD, and cause significant distress in those who suffer from them. A lack of understanding by medical professionals along with a lack of effective treatments often results in quite negative experiences of health care for people with FSD. There is little research about how FSD affect people who are older although some studies suggest that FSD can substantially lower quality of life for older people and increase the frequency with which they use health services.
‘Attachment’ describes the emotional connection that we make with other people. The ability to do this develops in infancy but is also affected by what happens to us later in life. In ideal circumstances, secure attachment allows the development of biological, social and psychological processes that help us to manage stress and cope with difficult experiences. There is evidence that these processes have been disrupted for people with FSD which causes their attachments to be less secure and changes how they experience distress. One possible consequence is that difficult experiences are not processed as emotions but are instead processed by the body as the physical symptoms that constitute an FSD. It has also been proposed that the distress caused by FSD symptoms contributes to making attachment less secure and perpetuating a vicious cycle.
The purpose of this study is to investigate whether there is a relationship between attachment security and severity of FSD symptoms and whether this can be explained by differences in the way emotions are processed, using the concept of ‘mentalized affectivity’. Depression and anxiety are often comorbid with FSD and the study will also explore this relationship further. The study will focus on people over the age of 45 because there is a lack of research regarding FSD in this age group, possibly because physical symptoms in older people are often assumed to be part of aging or other conditions. Understanding the factors that underly FSD is important as it may lead to more effective treatments that can help the many people whose lives are affected by these debilitating conditions.
The overall research aim is to investigate whether mentalized affectivity can explain the relationship between insecure attachment and FSD.
Research questions:
1. Does mentalized affectivity mediate the relationship between insecure attachment and severity of somatic symptoms in FSD?
2. Does mentalized affectivity mediate the relationship between attachment and depression/anxiety?
3. How is the proposed mediation model impacted by age?
4. Which of the three subcomponents of mentalized affectivity (identifying, processing and expressing emotions) plays the greatest role in any mediation?
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Procedure
Promotional materials will invite those interested in taking part in the study to follow a weblink to the online survey.
The online survey will consist of the following stages:
Initial participant information sheet – appendix 2
Consent form – appendix 3
Providing demographic data – appendix 4
Indicate which FSD they identify with and how long they have had these symptoms – appendix 5
Complete the following standardised psychological measures:
o Experiences in close relationships-revised (ECR-R) (Fraley, Waller, & Brennan, 2000) – appendix 6
o The mentalized affectivity scale (MAS) (Greenberg et al., 2017) – appendix 7
o 15-item somatization module from the Patient Health Questionnaire (PHQ-15) – appendix 8
o Brief Illness Perceptions Questionnaire (Brief IPQ) (Broadbent, Petrie, Main, & Weinman, 2006) – appendix 9
o Depression Anxiety Stress Scales-21 (DASS-21) – appendix 10
A debrief page – appendix 11
It is estimated that the surveys will take approximately 30 to 45 minutes to complete and will include the option to partially save and complete later.
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Edit: I looked for the appendices with the copies of the questionnaires, but they aren't there.
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