NCT05734677

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 11, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

January 11, 2023

Last Update Submit

February 8, 2023

Conditions

Emotional DysfunctionBorderline Personality Disorder

Outcome Measures

Primary Outcomes (4)

  • Changes from Baseline in Difficulties in emotion regulation scale (DERS)

    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)

    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)

    Informant-report measure of emotion dysregulation

    V2 (within two weeks after the end of the intervention)

  • Changes from Baseline in Emotion Dysregulation Inventory (EDI)

    Informant-report measure of emotion dysregulation

    V3 (3 months after the intervention)

Secondary Outcomes (20)

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

    V2 (within two weeks after the end of 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)

    V2 (within two weeks after the end of the intervention)

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

    V3 (3 months after the intervention)

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

    V2 (within two weeks after the end of the intervention)

  • +15 more secondary outcomes

Study Arms (1)

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

EXPERIMENTAL

an eight-week emotion regulation group intervention

Behavioral: Emotion regulation group

Interventions

Emotion regulation groupBEHAVIORAL

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

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

Eligibility Criteria

Age16 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Genève (HUG)

Geneva, 1205, Switzerland

RECRUITING

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Central Study Contacts

Camille Piguet

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD, PD

Study Record Dates

First Submitted

January 11, 2023

First Posted

February 21, 2023

Study Start

January 1, 2022

Primary Completion

September 6, 2023

Study Completion

December 31, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)