Emotion Regulation Group Study (EmoReg)

February 8, 2023 updated by: Camille Nemitz Piguet

Emotion Regulation Group Intervention for Late Adolescents: a Clinical Trial

A clinical trial to evaluate the effects of an eight-week emotion regulation group intervention designed for adolescents (16-20 years old) on the levels of emotion dysregulation both self-reported by the adolescent and reported by his/her parent/caregiver (pre-post comparison). The long-term effect will also be measured at a third-time point, three months after the end of the intervention. The intervention will consist of 90-minute sessions once a week for 8 weeks, in groups of eight participants. The intervention proposed for this study is an adaptation from different interventions already in use for adolescents in clinical practice, such as Dialectical Behavior Therapy (DBT), Mentalization-Based Treatment (MBT) and Mindfulness-Based Intervention (MBI).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged between 16 to 20 years old.
  • > 4 criteria of borderline symptoms (out of the 9 listed in the DSM-5) including emotional liability
  • French speaking
  • Availability during the whole study
  • Willingness in participating to the intervention and the research
  • Informed consent read and signed

Exclusion Criteria:

  • Current hospitalization
  • Psychotic disorder
  • Severe and persistent substance addiction
  • Antisocial personality disorder
  • Inability to participate in group sessions
  • Current pregnancy
  • Non-French speaking
  • Previous enrolment into the current study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: psychotherapeutic intervention with class risk A (low risk, no invasive procedure)
an eight-week emotion regulation group intervention
Behavioral: Emotion regulation group
90 minute sessions once a week for 8 weeks, in groups of eight participants. DBT, MBT and MBI inspired, psychoeducative intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes from Baseline in Difficulties in emotion regulation scale (DERS)
Time Frame: V2 (within two weeks after the end of the intervention)
36 items self-report scale: Higher scores suggest greater problems with emotion regulation.
V2 (within two weeks after the end of the intervention)
Changes from Baseline in Difficulties in emotion regulation scale (DERS)
Time Frame: V3 (3 months after the intervention)
36 items self-report scale: Higher scores suggest greater problems with emotion regulation.
V3 (3 months after the intervention)
Changes from Baseline in Emotion Dysregulation Inventory (EDI)
Time Frame: V2 (within two weeks after the end of the intervention)
Informant-report measure of emotion dysregulation
V2 (within two weeks after the end of the intervention)
Changes from Baseline in Emotion Dysregulation Inventory (EDI)
Time Frame: V3 (3 months after the intervention)
Informant-report measure of emotion dysregulation
V3 (3 months after the intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes from Baseline in Beck Depression Inventory (BDI-II)
Time Frame: V2 (within two weeks after the end of the intervention)
Self-report inventory scored from 0 to 63 (higher score = more severe depressive symptoms)
V2 (within two weeks after the end of the intervention)
Changes from Baseline in Beck Depression Inventory (BDI-II)
Time Frame: V3 (3 months after the intervention)
Self-report inventory scored from 0 to 63 (higher score = more severe depressive symptoms)
V3 (3 months after the intervention)
Changes from Baseline in State-Trait Anxiety Inventory (STAI)
Time Frame: V2 (within two weeks after the end of the intervention)
40 self-report items on a 4-point Likert scale: higher scores = greater anxiety
V2 (within two weeks after the end of the intervention)
Changes from Baseline in State-Trait Anxiety Inventory (STAI)
Time Frame: V3 (3 months after the intervention)
40 self-report items on a 4-point Likert scale: higher scores = greater anxiety
V3 (3 months after the intervention)
Changes from Baseline in self-report Family Attitude Scale (FAS)
Time Frame: V2 (within two weeks after the end of the intervention)
30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment)
V2 (within two weeks after the end of the intervention)
Changes from Baseline in self-report Family Attitude Scale (FAS)
Time Frame: V3 (3 months after the intervention)
30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment)
V3 (3 months after the intervention)
Changes from Baseline in parent-report Family Attitude Scale (FAS)
Time Frame: V2 (within two weeks after the end of the intervention)
30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment)
V2 (within two weeks after the end of the intervention)
Changes from Baseline in parent-report Family Attitude Scale (FAS)
Time Frame: V3 (3 months after the intervention)
30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment)
V3 (3 months after the intervention)
Changes from Baseline in Borderline Symptom List (BSL-23)
Time Frame: V2 (within two weeks after the end of the intervention)
Self-rating tool for Borderline Personality Disorder (BPD) symptoms: higher scores = more likely to have BPD and associated challenges
V2 (within two weeks after the end of the intervention)
Changes from Baseline in Borderline Symptom List (BSL-23)
Time Frame: V3 (3 months after the intervention)
Self-rating tool for BPD symptoms: higher scores = more likely to have BPD and associated challenges
V3 (3 months after the intervention)
Changes from Baseline in self-report Strength & Difficulties Questionnaire (SDQ)
Time Frame: V2 (within two weeks after the end of the intervention)
brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative.
V2 (within two weeks after the end of the intervention)
Changes from Baseline in self-report Strength & Difficulties Questionnaire (SDQ)
Time Frame: V3 (3 months after the intervention)
brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative.
V3 (3 months after the intervention)
Changes from Baseline in parent-report Strength & Difficulties Questionnaire (SDQ)
Time Frame: V2 (within two weeks after the end of the intervention)
brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative.
V2 (within two weeks after the end of the intervention)
Changes from Baseline in parent-report Strength & Difficulties Questionnaire (SDQ)
Time Frame: V3 (3 months after the intervention)
brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative.
V3 (3 months after the intervention)
Changes from Baseline in Cognitive Emotion Regulation Questionnaire (CERQ)
Time Frame: V2 (within two weeks after the end of the intervention)
Self-report measure designed to assess individual differences in cognitive regulation of emotions in response to stressful events. subscale scores can range from 4 to 20 with higher subscale scores indicating greater frequency of use of the specific cognitive strategy.
V2 (within two weeks after the end of the intervention)
Changes from Baseline in Cognitive Emotion Regulation Questionnaire (CERQ)
Time Frame: V3 (3 months after the intervention)
Self-report measure designed to assess individual differences in cognitive regulation of emotions in response to stressful events. subscale scores can range from 4 to 20 with higher subscale scores indicating greater frequency of use of the specific cognitive strategy.
V3 (3 months after the intervention)
Changes from Baseline in Kentucky inventory of mindfulness skills (KIMS)
Time Frame: V2 (within two weeks after the end of the intervention)
self-report measuring Mindfulness on four scales: Observing, Describing, Act With Awareness, and Accept Without Judgment. Higher scores = higher mindfulness
V2 (within two weeks after the end of the intervention)
Changes from Baseline in Kentucky inventory of mindfulness skills (KIMS)
Time Frame: V3 (3 months after the intervention)
self-report measuring Mindfulness on four scales: Observing, Describing, Act With Awareness, and Accept Without Judgment. Higher scores = higher mindfulness
V3 (3 months after the intervention)
Changes from Baseline in Perceived Parental Autonomy Support Scale (P-PASS)
Time Frame: V2 (within two weeks after the end of the intervention)
Measures parental autonomy-support and control of late adolescents and emerging adults. 24 items, assessed on a 7 point Likert scale.
V2 (within two weeks after the end of the intervention)
Changes from Baseline in Perceived Parental Autonomy Support Scale (P-PASS)
Time Frame: V3 (3 months after the intervention)
Measures parental autonomy-support and control of late adolescents and emerging adults. 24 items, assessed on a 7 point Likert scale.
V3 (3 months after the intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Camille Nemitz Piguet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fondation Privée des HUG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 6, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-01883

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings