EmoReg: Emotion Regulation Group Study

Sponsor
Camille Nemitz Piguet (Other)
Overall Status
Recruiting
CT.gov ID
NCT05734677
Collaborator
Fondation Privée des HUG (Other)
56
1
1
24
2.3

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Emotion regulation group
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
56 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Emotion Regulation Group Intervention for Late Adolescents: a Clinical Trial
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Sep 6, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Changes from Baseline in Difficulties in emotion regulation scale (DERS) [V2 (within two weeks after the end of the intervention)]

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

  2. Changes from Baseline in Difficulties in emotion regulation scale (DERS) [V3 (3 months after the intervention)]

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

  3. Changes from Baseline in Emotion Dysregulation Inventory (EDI) [V2 (within two weeks after the end of the intervention)]

    Informant-report measure of emotion dysregulation

  4. Changes from Baseline in Emotion Dysregulation Inventory (EDI) [V3 (3 months after the intervention)]

    Informant-report measure of emotion dysregulation

Secondary Outcome Measures

  1. Changes from Baseline in Beck Depression Inventory (BDI-II) [V2 (within two weeks after the end of the intervention)]

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

  2. Changes from Baseline in Beck Depression Inventory (BDI-II) [V3 (3 months after the intervention)]

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

  3. Changes from Baseline in State-Trait Anxiety Inventory (STAI) [V2 (within two weeks after the end of the intervention)]

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

  4. Changes from Baseline in State-Trait Anxiety Inventory (STAI) [V3 (3 months after the intervention)]

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

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

  6. Changes from Baseline in self-report Family Attitude Scale (FAS) [V3 (3 months after the intervention)]

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

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

  8. Changes from Baseline in parent-report Family Attitude Scale (FAS) [V3 (3 months after the intervention)]

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

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

  10. Changes from Baseline in Borderline Symptom List (BSL-23) [V3 (3 months after the intervention)]

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

  11. Changes from Baseline in self-report Strength & Difficulties Questionnaire (SDQ) [V2 (within two weeks after the end of the intervention)]

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

  12. Changes from Baseline in self-report Strength & Difficulties Questionnaire (SDQ) [V3 (3 months after the intervention)]

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

  13. Changes from Baseline in parent-report Strength & Difficulties Questionnaire (SDQ) [V2 (within two weeks after the end of the intervention)]

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

  14. Changes from Baseline in parent-report Strength & Difficulties Questionnaire (SDQ) [V3 (3 months after the intervention)]

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

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

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

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

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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 20 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpitaux Universitaires de Genève (HUG) Geneva Switzerland 1205

Sponsors and Collaborators

  • Camille Nemitz Piguet
  • Fondation Privée des HUG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Camille Nemitz Piguet, MD, PhD, PD, University of Geneva, Switzerland
ClinicalTrials.gov Identifier:
NCT05734677
Other Study ID Numbers:
  • 2021-01883
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2023