NCT04779619

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
903

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

10 months

First QC Date

February 23, 2021

Last Update Submit

March 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Perth Emotion Regulation Competency Inventory

    self report measure of ability to regulate positive and negative emotions

    at recruitment

Secondary Outcomes (1)

  • Difficulties in Emotion Regulation Scale - 36

    at recruitment

Other Outcomes (1)

  • Five Facets Mindfulness Questionnaire - 15

    at recruitment

Study Arms (3)

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

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)

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)

Other: Online self-report questionnaire completion

Interventions

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.

Clinical Group AClinical Group BNon-clinical Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

NHS staff for non-clinical group Primary care mental health service users for clinical groups

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sussex Partnership NHS Foundation Trust

Brighton, Sussex, United Kingdom

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2021

First Posted

March 3, 2021

Study Start

March 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations