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Emotional DysfunctionEmoRegNCT05734677

Emotion Regulation Group Study

A study testing Emotion regulation group in people with Emotional Dysfunction and Borderline Personality Disorder, run by Camille Nemitz Piguet at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 16 to 20 yearsHealthy volunteers can take part
What is being tested?
Emotion regulation group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteSwitzerland
Study dates
1 Jan 2022to 31 Dec 2023
Phase
Interventional
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 16 to 20 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Camille Piguet contact

+41 79 668 75 07

camille.piguet@unige.ch

Switzerland1 site, 1 recruiting

  • Hôpitaux Universitaires de Genève (HUG)

    Geneva, 1205

    Nader Perroud, Pr, Nader.Perroud@hcuge.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: 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).

Being tested
Emotion regulation group
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.

  • Emotion regulation groupBehavioural

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

Study groups in NCT05734677
Study groupRoleWhat they receive
psychotherapeutic intervention with class risk A (low risk, no invasive procedure)Experimentalan eight-week emotion regulation group intervention
Receives: Behavioral: Emotion regulation group

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 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.

    Measured: V3 (3 months after the intervention)

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

    Informant-report measure of emotion dysregulation

    Measured: 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

    Measured: V3 (3 months after the intervention)

Secondary outcomes (20)

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

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

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: V3 (3 months after the intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2023
  2. Study start1 Jan 2022
  3. Primary completion6 Sep 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05734677
Sponsor's protocol ID
2021-01883
Acronym
EmoReg
Status last verified
Feb 2023
First submitted
11 Jan 2023
Last updated
21 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Emotion regulation group in people with Emotional Dysfunction and Borderline Personality Disorder, run by Camille Nemitz Piguet at 1 site in Switzerland.

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 6 inclusion and 8 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 21 Feb 2023. 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 Switzerland. 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?

Contact Camille Piguet (+41 79 668 75 07, camille.piguet@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from Baseline in Difficulties in emotion regulation scale (DERS) (time frame: V2 (within two weeks after the end of the intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05734677.

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 21 Feb 2023.

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