- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05734677
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
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
56
Phase
- 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
- Name: Camille Piguet
- Phone Number: +41 79 668 75 07
- Email: camille.piguet@unige.ch
Study Locations
-
-
-
Geneva, Switzerland, 1205
- Recruiting
- Hôpitaux universitaires de Genève (HUG)
-
Contact:
- Nader Perroud, Pr
- Email: Nader.Perroud@hcuge.ch
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-
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
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 |
Intervention / Treatment |
---|---|
Experimental: psychotherapeutic intervention with class risk A (low risk, no invasive procedure)
an eight-week emotion regulation group intervention
|
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
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
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
Collaborators
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)
January 1, 2022
Primary Completion (Anticipated)
September 6, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
January 11, 2023
First Submitted That Met QC Criteria
February 8, 2023
First Posted (Estimate)
February 20, 2023
Study Record Updates
Last Update Posted (Estimate)
February 20, 2023
Last Update Submitted That Met QC Criteria
February 8, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
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