Emotional InstabilityEMERNCT04779619
Exploring a New Measure of Emotion Regulation
An observational study of Emotional Instability and Borderline Personality, run by Sussex Partnership NHS Foundation Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emotional Instability, Borderline Personality
- What is being tested?
- Online self-report questionnaire completion
- How many people
- 903 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: NHS staff for non-clinical group Primary care mental health service users for clinical groups
Who may be able to join
- All participants will be 18 or older. Non-clinical Group: people who score below clinical cut off on measures of anxiety and depression (scoring <10 on PHQ-9 and <8 on GAD-7) and emotionally unstable personality traits (BSL-23) and are not currently using mental health services.
- Clinical Group A: people who are accessing treatment through IAPT services and score above clinical cut off on measures of anxiety and/or depression (>9 on PHQ-9 and/or >7 on GAD-7) but below clinical cut off on a measure of emotionally unstable personality traits (BSL-23) Clinical Group B: people who are accessing treatment through IAPT services and score above clinical cut off on (BSL-23) a measure of emotionally unstable personality traits (irrespective of their scores on the PHQ-9 and GAD-7).
Who cannot join
- Non-clinical Group: people who have been recruited as part of the non-clinical group but who score above clinical cut off on any of the symptom measures will be excluded rather than transferred to the clinical group as they are non-treatment seeking.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sussex Partnership NHS Foundation Trust
Brighton, Sussex
About this study
Official title: An Online Survey to Explore the Psychometric Properties of a New and Theory-driven Measure of Emotion Regulation (the Perth Emotion Regulation Competency Inventory) When Used in a Range of Clinical and Non-clinical Populations.
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.
Read the detailed 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 :
- measure emotion regulation across both negative and positive emotions
- measure across all four components of emotion regulation
- 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.
- Conditions
- Emotional Instability, Borderline Personality
- Being tested
- Online self-report questionnaire completion
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online self-report questionnaire completionOther
After reading the PIS and completing the consent page on Qualtrics participants will then be presented with the demographic, PHQ-9, GAD-7 and BSL-23 questionnaires which will be used to determine later allocation of their data to one of the three group. They will then be presented with the PERCI, FFMQ-15 and DERS.
| Study group | Role | What they receive |
|---|---|---|
| Non-clinical Control | people who score below clinical cut off on measures of anxiety and depression (scoring <10 on PHQ-9 and <8 on GAD-7) and emotionally unstable personality traits (BSL-23) and are not currently using mental health services Receives: Other: Online self-report questionnaire completion | |
| Clinical Group A | people who are accessing treatment through IAPT services and score above clinical cut off on measures of anxiety and/or depression (>9 on PHQ-9 and/or >7 on GAD-7) but below clinical cut off on a measure of emotionally unstable personality traits (BSL-23) Receives: Other: Online self-report questionnaire completion | |
| Clinical Group B | people who are accessing treatment through IAPT services and score above clinical cut off on (BSL-23) a measure of emotionally unstable personality traits (irrespective of their scores on the PHQ-9 and GAD-7) Receives: Other: Online self-report questionnaire completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perth Emotion Regulation Competency Inventory
self report measure of ability to regulate positive and negative emotions
Measured: at recruitment
Secondary outcomes (1)
Difficulties in Emotion Regulation Scale - 36
self report measure of difficulties in regulating negative emotions
Measured: at recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Mar 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 903 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sussex Partnership NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sussex
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779619
- Sponsor's protocol ID
- 264525 EMER
- Acronym
- EMER
- Status last verified
- Mar 2021
- First submitted
- 23 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Survey to Explore the Psychometric Properties of a New and Theory-driven Measure of Emotion Regulation (the Perth Emotion Regulation Competency Inventory) When Used in a Range of Clinical and Non-clinical Populations.
- ClinicalTrials.gov ID
- NCT04779619
- Acronym / sponsor ID
- EMER / 264525 EMER
- Conditions
- Emotional Instability, Borderline Personality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 903 participants (estimated)
- Lead sponsor
- Sussex Partnership NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sussex
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 :
- measure emotion regulation across both negative and positive emotions
- measure across all four components of emotion regulation
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-clinical Control | – | Other: Online self-report questionnaire completionpeople who score below clinical cut off on measures of anxiety and depression (scoring <10 on PHQ-9 and <8 on GAD-7) and emotionally unstable personality traits (BSL-23) and are not currently using mental health services |
| Clinical Group A | – | Other: Online self-report questionnaire completionpeople who are accessing treatment through IAPT services and score above clinical cut off on measures of anxiety and/or depression (>9 on PHQ-9 and/or >7 on GAD-7) but below clinical cut off on a measure of emotionally unstable personality traits (BSL-23) |
| Clinical Group B | – | Other: Online self-report questionnaire completionpeople who are accessing treatment through IAPT services and score above clinical cut off on (BSL-23) a measure of emotionally unstable personality traits (irrespective of their scores on the PHQ-9 and GAD-7) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- NHS staff for non-clinical group Primary care mental health service users for clinical groups
Key inclusion criteria (2 listed)
- All participants will be 18 or older. Non-clinical Group: people who score below clinical cut off on measures of anxiety and depression (scoring <10 on PHQ-9 and <8 on GAD-7) and emotionally unstable personality traits (BSL-23) and are not currently using mental health services.
- Clinical Group A: people who are accessing treatment through IAPT services and score above clinical cut off on measures of anxiety and/or depression (>9 on PHQ-9 and/or >7 on GAD-7) but below clinical cut off on a measure of emotionally unstable personality traits (BSL-23) Clinical Group B: people who are accessing treatment through IAPT services and score above clinical cut off on (BSL-23) a measure of emotionally unstable personality traits (irrespective of their scores on the PHQ-9 and GAD-7).
Key exclusion criteria (1 listed)
- Non-clinical Group: people who have been recruited as part of the non-clinical group but who score above clinical cut off on any of the symptom measures will be excluded rather than transferred to the clinical group as they are non-treatment seeking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online self-report questionnaire completionAfter reading the PIS and completing the consent page on Qualtrics participants will then be presented with the demographic, PHQ-9, GAD-7 and BSL-23 questionnaires which will be used to determine later allocation of their data to one of the three group. They will then be presented with the PERCI, FFMQ-15 and DERS. | Other | Clinical Group A, Clinical Group B, Non-clinical Control |
Primary outcome
Perth Emotion Regulation Competency Inventory
Time frame: at recruitment
self report measure of ability to regulate positive and negative emotions
1 secondary outcome
Difficulties in Emotion Regulation Scale - 36
Time frame: at recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emotional Instability and Borderline Personality, run by Sussex Partnership NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perth Emotion Regulation Competency Inventory (time frame: at recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.