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Clinical Trials/NCT05734677
NCT05734677
Recruiting
N/A

Emotion Regulation Group Intervention for Late Adolescents: a Clinical Trial

Camille Nemitz Piguet1 site in 1 country56 target enrollmentJanuary 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Emotional Dysfunction
Sponsor
Camille Nemitz Piguet
Enrollment
56
Locations
1
Primary Endpoint
Changes from Baseline in Difficulties in emotion regulation scale (DERS)
Status
Recruiting
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Camille Nemitz Piguet
Responsible Party
Sponsor Investigator
Principal Investigator

Camille Nemitz Piguet

MD, PhD, PD

University of Geneva, Switzerland

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Changes from Baseline in Emotion Dysregulation Inventory (EDI)

Time Frame: V3 (3 months after the intervention)

Informant-report measure of emotion dysregulation

Secondary Outcomes

  • Changes from Baseline in parent-report Family Attitude Scale (FAS)(V3 (3 months after the intervention))
  • Changes from Baseline in self-report Strength & Difficulties Questionnaire (SDQ)(V3 (3 months after the intervention))
  • Changes from Baseline in Beck Depression Inventory (BDI-II)(V3 (3 months after the intervention))
  • Changes from Baseline in State-Trait Anxiety Inventory (STAI)(V3 (3 months after the intervention))
  • Changes from Baseline in parent-report Strength & Difficulties Questionnaire (SDQ)(V3 (3 months after the intervention))
  • Changes from Baseline in Cognitive Emotion Regulation Questionnaire (CERQ)(V3 (3 months after the intervention))
  • Changes from Baseline in Kentucky inventory of mindfulness skills (KIMS)(V3 (3 months after the intervention))
  • Changes from Baseline in Perceived Parental Autonomy Support Scale (P-PASS)(V3 (3 months after the intervention))
  • Changes from Baseline in Borderline Symptom List (BSL-23)(V3 (3 months after the intervention))
  • Changes from Baseline in self-report Family Attitude Scale (FAS)(V3 (3 months after the intervention))

Study Sites (1)

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