Emotion Regulation Group Study

Not Applicable

Recruiting

• Conditions: Borderline Personality Disorder; Emotional Dysfunction
• Interventions: Behavioral: Emotion regulation group

• Registration Number: NCT05734677
• Lead Sponsor: Camille Nemitz Piguet

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2023-01-11
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-08
• Last Update Submitted: 2023-02-08
• Study First Posted: 2023-02-21
• Last Update Posted: 2023-02-21
• Primary Completion: 2023-09-06
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
psychotherapeutic intervention with class risk A (low risk, no invasive procedure)	Emotion regulation group	an eight-week emotion regulation group intervention

Primary Outcome Measures

Name	Time	Method
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.
Changes from Baseline in Emotion Dysregulation Inventory (EDI)	V3 (3 months after the intervention)	Informant-report measure of emotion dysregulation

Secondary Outcome Measures

Name	Time	Method
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)
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.
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)
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
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.
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.
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
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.
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
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)

Trial Locations

Locations (1)

Hôpitaux Universitaires de Genève (HUG); 🇨🇭 Geneva, Switzerland