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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05734677
Other study ID # 2021-01883
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2023

Study information

Verified date February 2023
Source University of Geneva, Switzerland
Contact Camille Piguet
Phone +41 79 668 75 07
Email camille.piguet@unige.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 56
Est. completion date December 31, 2023
Est. primary completion date September 6, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 20 Years
Eligibility 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


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.

Locations

Country Name City State
Switzerland Hôpitaux Universitaires de Genève (HUG) Geneva

Sponsors (2)

Lead Sponsor Collaborator
Camille Nemitz Piguet Fondation Privée des HUG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary Changes from Baseline in Emotion Dysregulation Inventory (EDI) Informant-report measure of emotion dysregulation V2 (within two weeks after the end of the intervention)
Primary Changes from Baseline in Emotion Dysregulation Inventory (EDI) Informant-report measure of emotion dysregulation V3 (3 months after the intervention)
Secondary Changes from Baseline in Beck Depression Inventory (BDI-II) Self-report inventory scored from 0 to 63 (higher score = more severe depressive symptoms) V2 (within two weeks after the end of the intervention)
Secondary Changes from Baseline in Beck Depression Inventory (BDI-II) Self-report inventory scored from 0 to 63 (higher score = more severe depressive symptoms) V3 (3 months after the intervention)
Secondary Changes from Baseline in State-Trait Anxiety Inventory (STAI) 40 self-report items on a 4-point Likert scale: higher scores = greater anxiety V2 (within two weeks after the end of the intervention)
Secondary Changes from Baseline in State-Trait Anxiety Inventory (STAI) 40 self-report items on a 4-point Likert scale: higher scores = greater anxiety V3 (3 months after the intervention)
Secondary Changes from Baseline in self-report Family Attitude Scale (FAS) 30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment) V2 (within two weeks after the end of the intervention)
Secondary Changes from Baseline in self-report Family Attitude Scale (FAS) 30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment) V3 (3 months after the intervention)
Secondary Changes from Baseline in parent-report Family Attitude Scale (FAS) 30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment) V2 (within two weeks after the end of the intervention)
Secondary Changes from Baseline in parent-report Family Attitude Scale (FAS) 30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment) V3 (3 months after the intervention)
Secondary Changes from Baseline in Borderline Symptom List (BSL-23) Self-rating tool for Borderline Personality Disorder (BPD) symptoms: higher scores = more likely to have BPD and associated challenges V2 (within two weeks after the end of the intervention)
Secondary Changes from Baseline in Borderline Symptom List (BSL-23) Self-rating tool for BPD symptoms: higher scores = more likely to have BPD and associated challenges V3 (3 months after the intervention)
Secondary Changes from Baseline in self-report Strength & Difficulties Questionnaire (SDQ) brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative. V2 (within two weeks after the end of the intervention)
Secondary Changes from Baseline in self-report Strength & Difficulties Questionnaire (SDQ) brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative. V3 (3 months after the intervention)
Secondary Changes from Baseline in parent-report Strength & Difficulties Questionnaire (SDQ) brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative. V2 (within two weeks after the end of the intervention)
Secondary Changes from Baseline in parent-report Strength & Difficulties Questionnaire (SDQ) brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative. V3 (3 months after the intervention)
Secondary Changes from Baseline in Cognitive Emotion Regulation Questionnaire (CERQ) 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. V2 (within two weeks after the end of the intervention)
Secondary Changes from Baseline in Cognitive Emotion Regulation Questionnaire (CERQ) 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. V3 (3 months after the intervention)
Secondary Changes from Baseline in Kentucky inventory of mindfulness skills (KIMS) self-report measuring Mindfulness on four scales: Observing, Describing, Act With Awareness, and Accept Without Judgment. Higher scores = higher mindfulness V2 (within two weeks after the end of the intervention)
Secondary Changes from Baseline in Kentucky inventory of mindfulness skills (KIMS) self-report measuring Mindfulness on four scales: Observing, Describing, Act With Awareness, and Accept Without Judgment. Higher scores = higher mindfulness V3 (3 months after the intervention)
Secondary Changes from Baseline in Perceived Parental Autonomy Support Scale (P-PASS) Measures parental autonomy-support and control of late adolescents and emerging adults. 24 items, assessed on a 7 point Likert scale. V2 (within two weeks after the end of the intervention)
Secondary Changes from Baseline in Perceived Parental Autonomy Support Scale (P-PASS) Measures parental autonomy-support and control of late adolescents and emerging adults. 24 items, assessed on a 7 point Likert scale. V3 (3 months after the intervention)
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