ClinicalTrials.gg
Status unknownNCT05734677EmoRegUpdated Feb 21, 2023

Emotion Regulation Group Study

An interventional study of Emotion regulation group in Emotional Dysfunction and Borderline Personality Disorder, sponsored by Camille Nemitz Piguet. Status unknown at 1 site in Switzerland. Open to participants aged 16 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-21.

Sponsored by Camille Nemitz Piguet · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jan 2022, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
16 Years to 20 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Emotional Dysfunction
  • Borderline Personality Disorder
03

In context

Borderline Personality Disorder

278 studies on the registry are indexed under Borderline Personality Disorder; 70 are open to participants now.

This study's planned enrollment of 56 is below the median of 70 across 221 interventional studies indexed under Borderline Personality Disorder.

Browse Borderline Personality Disorder studies →

Lead sponsor

This is the only study on the registry with Camille Nemitz Piguet as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    psychotherapeutic intervention with class risk A (low risk, no invasive procedure)

    an eight-week emotion regulation group intervention

    Behavioral: Emotion regulation group

Interventions

  • BehavioralEmotion regulation group

    90 minute sessions once a week for 8 weeks, in groups of eight participants. DBT, MBT and MBI inspired, psychoeducative intervention.

06

What researchers measure

Primary outcomes

  1. Changes from Baseline in Difficulties in emotion regulation scale (DERS)

    36 items self-report scale: Higher scores suggest greater problems with emotion regulation.

    Time frame: V2 (within two weeks after the end of the intervention)

  2. Changes from Baseline in Difficulties in emotion regulation scale (DERS)

    36 items self-report scale: Higher scores suggest greater problems with emotion regulation.

    Time frame: V3 (3 months after the intervention)

  3. Changes from Baseline in Emotion Dysregulation Inventory (EDI)

    Informant-report measure of emotion dysregulation

    Time frame: V2 (within two weeks after the end of the intervention)

  4. Changes from Baseline in Emotion Dysregulation Inventory (EDI)

    Informant-report measure of emotion dysregulation

    Time frame: V3 (3 months after the intervention)

Secondary outcomes

  1. Changes from Baseline in Beck Depression Inventory (BDI-II)

    Self-report inventory scored from 0 to 63 (higher score = more severe depressive symptoms)

    Time frame: V2 (within two weeks after the end of the intervention)

  2. Changes from Baseline in Beck Depression Inventory (BDI-II)

    Self-report inventory scored from 0 to 63 (higher score = more severe depressive symptoms)

    Time frame: V3 (3 months after the intervention)

  3. Changes from Baseline in State-Trait Anxiety Inventory (STAI)

    40 self-report items on a 4-point Likert scale: higher scores = greater anxiety

    Time frame: V2 (within two weeks after the end of the intervention)

  4. Changes from Baseline in State-Trait Anxiety Inventory (STAI)

    40 self-report items on a 4-point Likert scale: higher scores = greater anxiety

    Time frame: V3 (3 months after the intervention)

  5. Changes from Baseline in self-report Family Attitude Scale (FAS)

    30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment)

    Time frame: V2 (within two weeks after the end of the intervention)

  6. Changes from Baseline in self-report Family Attitude Scale (FAS)

    30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment)

    Time frame: V3 (3 months after the intervention)

  7. Changes from Baseline in parent-report Family Attitude Scale (FAS)

    30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment)

    Time frame: V2 (within two weeks after the end of the intervention)

  8. Changes from Baseline in parent-report Family Attitude Scale (FAS)

    30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment)

    Time frame: V3 (3 months after the intervention)

  9. Changes from Baseline in Borderline Symptom List (BSL-23)

    Self-rating tool for Borderline Personality Disorder (BPD) symptoms: higher scores = more likely to have BPD and associated challenges

    Time frame: V2 (within two weeks after the end of the intervention)

  10. Changes from Baseline in Borderline Symptom List (BSL-23)

    Self-rating tool for BPD symptoms: higher scores = more likely to have BPD and associated challenges

    Time frame: V3 (3 months after the intervention)

  11. Changes from Baseline in self-report Strength & Difficulties Questionnaire (SDQ)

    brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative.

    Time frame: V2 (within two weeks after the end of the intervention)

  12. Changes from Baseline in self-report Strength & Difficulties Questionnaire (SDQ)

    brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative.

    Time frame: V3 (3 months after the intervention)

  13. Changes from Baseline in parent-report Strength & Difficulties Questionnaire (SDQ)

    brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative.

    Time frame: V2 (within two weeks after the end of the intervention)

  14. Changes from Baseline in parent-report Strength & Difficulties Questionnaire (SDQ)

    brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative.

    Time frame: V3 (3 months after the intervention)

  15. Changes from Baseline in Cognitive Emotion Regulation Questionnaire (CERQ)

    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.

    Time frame: V2 (within two weeks after the end of the intervention)

  16. Changes from Baseline in Cognitive Emotion Regulation Questionnaire (CERQ)

    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.

    Time frame: V3 (3 months after the intervention)

  17. Changes from Baseline in Kentucky inventory of mindfulness skills (KIMS)

    self-report measuring Mindfulness on four scales: Observing, Describing, Act With Awareness, and Accept Without Judgment. Higher scores = higher mindfulness

    Time frame: V2 (within two weeks after the end of the intervention)

  18. Changes from Baseline in Kentucky inventory of mindfulness skills (KIMS)

    self-report measuring Mindfulness on four scales: Observing, Describing, Act With Awareness, and Accept Without Judgment. Higher scores = higher mindfulness

    Time frame: V3 (3 months after the intervention)

  19. Changes from Baseline in Perceived Parental Autonomy Support Scale (P-PASS)

    Measures parental autonomy-support and control of late adolescents and emerging adults. 24 items, assessed on a 7 point Likert scale.

    Time frame: V2 (within two weeks after the end of the intervention)

  20. Changes from Baseline in Perceived Parental Autonomy Support Scale (P-PASS)

    Measures parental autonomy-support and control of late adolescents and emerging adults. 24 items, assessed on a 7 point Likert scale.

    Time frame: V3 (3 months after the intervention)

07

Study locations

1 of 1 sites recruiting
  • Hôpitaux Universitaires de Genève (HUG)
    Geneva, 1205, Switzerland
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2022 (actual). Primary completion is estimated for Sep 2023, 20 months after the start.

Of 105 non-industry interventional studies with no phase under Borderline Personality Disorder, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 54. This study's planned 20 months is below that.

Counting every sponsor, half of 107 studies reached it within 35 months; a quarter within 24 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 11, 2023
First posted
Feb 21, 2023
StartActual
Jan 1, 2022
Primary completionEst.
Sep 6, 2023
CompletionEst.
Dec 31, 2023
Last update
Feb 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05734677
Lead sponsor
Camille Nemitz Piguet
Collaborators
Fondation Privée des HUG
Responsible party
Camille Nemitz Piguet (MD, PhD, PD, University of Geneva, Switzerland) — Sponsor-investigator
First posted
Feb 21, 2023
Start date
Jan 1, 2022
Primary completion
Sep 6, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Feb 21, 2023

Study contacts

Camille Piguet
Contact
camille.piguet@unige.ch
+41 79 668 75 07

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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