Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04779619 |
| Other study ID # |
264525 EMER |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
Sussex Partnership NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background: Emotion regulation has been established as an important concept in mental health
research across a range of different diagnoses. There are numerous questionnaires used to
measure emotion regulation but only one (the Perth Emotion Regulation Competency Inventory -
PERCI) is based on the most recent and widely accepted model of emotion regulation (Gross'
extended process model of emotion regulation). This recently developed measure has not yet
been extensively used or psychometrically tested in clinical populations. However, it may be
more theoretically and psychometrically sound than other measures widely used in the research
literature to date.
Methods/Design: An online survey including this new measure with other relevant
questionnaires will sample non-clinical and two specific clinical populations in order to
explore the reliability, validity and utility of this measure.
Discussion: This will inform the ways in which emotion regulation competency is measured in
future research and clinical practice.
Description:
Despite the term 'emotion' being commonly used in day-to-day language, within the research
literature on emotion regulation (both within the health field and more broadly) there is
great variety in the terminology and scales of measurement used. So much so that Buck
describes the field as "conceptual and definitional chaos" (Buck 1990, p.330). However Gross
has recently renewed his extended process model of emotion regulation and this is now a
widely established model although used more frequently in cognition research than in health
research (see Gross 2015 for a full description of the model)
In 1998 Gross described emotion regulation as "shaping which emotions one has, when one has
them, and how one experiences or expresses those emotions" (Gross 1998). One of the key
points which this model suggests is that each of the 5 steps offer potential for emotion
regulation and that there is no limit as to the number or type of activities which might
serve this purpose.
It is this ability to regulate emotions (i.e. a person's capacity to successfully modify the
trajectory of their emotions), which has been established as an important but complex concept
in health research. A number of systematic reviews have explored what is known about emotion
regulation across a variety of mental health diagnoses (e.g. Sloan et al 2017, Hu et al
2014). Fernandez et al 2014 argue that it is a key transdiagnostic concept using the Research
Domain Criteria framework.
As poor emotion regulation has therefore been implicated in the onset and maintenance of a
range of mental health conditions, it has subsequently been the target of a number of
psychological interventions. Given that affective instability and reactivity, and the use of
problematic regulation strategies, are some of the core criteria for EUPD, many of the
treatment approaches for this clinical group address emotion regulation. It remains unclear
what the mediating or moderating role of emotion regulation is in influencing treatment
outcome. A comprehensive, theoretically and psychometrically sound instrument to measure
emotion regulation is therefore vital for the development or adaptation of these types of
interventions and the subsequent research examining mechanisms of action.
There are numerous self-report questionnaires which are used to quantify emotion regulation.
However many of these have psychometric and/or theoretical weaknesses which could potentially
impact on the quality of research and the conclusions drawn from this research. Preece and
colleagues (2018) describe and evaluate the existing 13 self-report measures relevant to the
concept of emotion regulation. In summary they argue that none of these scales :
1. measure emotion regulation across both negative and positive emotions
2. measure across all four components of emotion regulation
3. clearly distinguish between emotion recognition/description (alexithymia) and emotion
regulation.
Preece and colleagues therefore developed the PERCI on the basis of Gross' model in order to
overcome these deficits. Preece and colleagues (2018) published research outlining the
process of scale development and reported good indices of reliability and validity for this
measure in a non-clinical population. They recommend replication of reliability and validity
research in clinical populations. Factor structure was examined through the use of a series
of confirmatory factor analyses. They found the factor structure to be replicable and
consistent with the theoretical basis of the Gross model. In the non-clinical population (N =
1175) the PERCI total score had an excellent internal reliability (Cronbach's alpha α) of
0.95. They also reported excellent internal reliability of the four subscales of the PERCI:
Negative emotion regulation (α 0.93), Positive emotion regulation (α 0.92), General
facilitating hedonic goals (α 0.94) and Positive containing emotions (α 0.93). Concurrent and
criterion validity analyses were also reported and confirmed the hypotheses of the
researchers in that higher reporting of emotion regulation difficulties on the PERCI was
associated with measures of maladaptive regulation strategies, higher levels of alexithymia,
more insecure attachments and higher levels of depression, anxiety and stress.
The current study will be a cross-sectional survey using online self-report questionnaires.
The study seeks to test the psychometric properties of the scale in mental health
populations, as poor emotion regulation is particularly pertinent yet the psychometric
properties of the scale are unknown in this population. It is possible that the factor
structure and other psychometric properties of the scale are different between clinical and
non-clinical populations and this could have important implications for theory, research and
practice.
The clinical group will be separated in to people with low and high 'EUPD' traits to allow
comparison. The diagnosis of EUPD is controversial and frequently stigmatised. Some people
using mental health services will meet criteria for EUPD but not have been told this directly
by clinicians, others may have been told they have EUPD informally or after insufficient
assessment. This complexity and heterogeneity has led to the decision not to rely on reported
diagnosis but to measure current EUPD symptomatology and allocate people to two clinical
groups on the basis of clinical cut-offs.
The population accessing the NHS talking therapies service, Improving Access to Psychological
Therapy (IAPT), has been found to have high rates of people meeting diagnostic criteria for
EUPD (Hepgel and colleagues 2016) and even higher levels of people with traits of personality
disorder. As this is a large and relatively accessible group of people this is the population
the researchers will target for recruitment for the clinical group.
The researchers will initially recruit a non-clinical group from NHS staff members as they
may be more representative of the general population in terms of broad demographics than a
student sample.
