Clinical trial NCT05734677: Emotion Regulation Group Study
Official title: Emotion Regulation Group Intervention for Late Adolescents: a Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotional Dysfunction
Borderline Personality Disorder
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
Collaborators: name: Fondation Privée des HUG
First posted: 2023-02-21
Enrollment: 56
Sex: ALL
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Changes from Baseline in Difficulties in emotion regulation scale (DERS)
timeFrame: V2 (within two weeks after the end of the intervention)
measure: Changes from Baseline in Difficulties in emotion regulation scale (DERS)
timeFrame: V3 (3 months after the intervention)
measure: Changes from Baseline in Emotion Dysregulation Inventory (EDI)
timeFrame: V2 (within two weeks after the end of the intervention)
measure: Changes from Baseline in Emotion Dysregulation Inventory (EDI)
timeFrame: V3 (3 months after the intervention)
Secondary outcomes:
measure: Changes from Baseline in Beck Depression Inventory (BDI-II)
timeFrame: V2 (within two weeks after the end of the intervention)
measure: Changes from Baseline in Beck Depression Inventory (BDI-II)
timeFrame: V3 (3 months after the intervention)
measure: Changes from Baseline in State-Trait Anxiety Inventory (STAI)
timeFrame: V2 (within two weeks after the end of the intervention)
measure: Changes from Baseline in State-Trait Anxiety Inventory (STAI)
timeFrame: V3 (3 months after the intervention)
measure: Changes from Baseline in self-report Family Attitude Scale (FAS)
timeFrame: V2 (within two weeks after the end of the intervention)
measure: Changes from Baseline in self-report Family Attitude Scale (FAS)
timeFrame: V3 (3 months after the intervention)
measure: Changes from Baseline in parent-report Family Attitude Scale (FAS)
timeFrame: V2 (within two weeks after the end of the intervention)
measure: Changes from Baseline in parent-report Family Attitude Scale (FAS)
timeFrame: V3 (3 months after the intervention)
measure: Changes from Baseline in Borderline Symptom List (BSL-23)
timeFrame: V2 (within two weeks after the end of the intervention)
measure: Changes from Baseline in Borderline Symptom List (BSL-23)
timeFrame: V3 (3 months after the intervention)
measure: Changes from Baseline in self-report Strength & Difficulties Questionnaire (SDQ)
timeFrame: V2 (within two weeks after the end of the intervention)
measure: Changes from Baseline in self-report Strength & Difficulties Questionnaire (SDQ)
timeFrame: V3 (3 months after the intervention)
measure: Changes from Baseline in parent-report Strength & Difficulties Questionnaire (SDQ)
timeFrame: V2 (within two weeks after the end of the intervention)
measure: Changes from Baseline in parent-report Strength & Difficulties Questionnaire (SDQ)
timeFrame: V3 (3 months after the intervention)
measure: Changes from Baseline in Cognitive Emotion Regulation Questionnaire (CERQ)
timeFrame: V2 (within two weeks after the end of the intervention)
measure: Changes from Baseline in Cognitive Emotion Regulation Questionnaire (CERQ)
timeFrame: V3 (3 months after the intervention)
measure: Changes from Baseline in Kentucky inventory of mindfulness skills (KIMS)
timeFrame: V2 (within two weeks after the end of the intervention)
measure: Changes from Baseline in Kentucky inventory of mindfulness skills (KIMS)
timeFrame: V3 (3 months after the intervention)
measure: Changes from Baseline in Perceived Parental Autonomy Support Scale (P-PASS)
timeFrame: V2 (within two weeks after the end of the intervention)
measure: Changes from Baseline in Perceived Parental Autonomy Support Scale (P-PASS)
timeFrame: V3 (3 months after the intervention)
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève (HUG)
Study officials:
References: