Improving Emotion Regulation Flexibility: Testing the Efficacy of an Emotion Regulation Program in College Students

Not Applicable

• Conditions: Emotion Regulation; Anxiety Depression

• Registration Number: NCT05390034
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

The main objective of this RCT is to test the efficacy of an emotion regulation group program (i.e., ART program) in college students, compared to an active control group (i.e., relaxation program). Using multilevel analyses, we expect an improvement in anxious-depressive symptomatology for both groups. However, we expect the ART group to improve specifically on emotion regulation flexibility ability, and the last to be a mediative variable on mental health.

Detailed Description

Emotion regulation (ER) is a process associated with difficulties in mental health. Given its transdiagnostic features, its improvement could facilitate the recovery of various psychological issues. A limit of current studies is the lack of knowledge regarding whether available interventions improve ER flexibility (i.e., the ability to implement ER strategies in line with contextual demands), even though this capacity has been associated with better mental health and well-being. Therefore, the aim of the study is to test the efficacy of a 9-weeks ER group program (the Affect Regulation Training-ART), using the most appropriate measures (i.e., experience sampling method) in a student population. Plus, the goal of the study is to explore the potential mediative role of ER flexibility on mental health improvement.

This RCT will compare the ART program group to an active control group (a relaxation program) in 100 participants. To test the mediative role of ER flexibility on mental health, daily measures will be used before, during, and after the interventions to evaluate the extent to which participants are flexible in their ER.

Using multilevel analyses, we expect an improvement in anxious-depressive symptomatology for both groups. However, we expect the ART group to improve specifically on ER flexibility ability, and the last to be a mediative variable on mental health.

This study will enhance knowledge on interventions for students and the impact of interventions on ER flexibility. Also, this research will improve knowledge on ecological measures for assessing the effect of interventions. Overall, this project represents new opportunities to improve ER skills to improve mental health in undergraduate students.

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-05-23
• Study First Posted: 2022-05-25
• Study Start: 2022-09-01
• Primary Completion: 2022-09-01
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-07
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Grenoble Alpes University student
• Having a smartphone that can host PIEL application
• BDI ≥ 10 and ≤ 30
• Reading, understanding, and speaking French
• Signed free and informed consent

Non inclusion Criteria:

• Participation in another study related to emotion regulation
• Participation in other psychotherapies involving cognitive and behavioral intervention (actual or in the past year)
• Changes in drug treatments in the last two months
• Student in psychology
• Individuals concerned in the articles L1121-6 à L1121-8 of CSP (i.e., protected individuals)
• Suicidal risk (BDI II, item suicidal thoughts > 1 or MINI suicide, low intensity)
• Anorexia nervose (MINI)
• Schizophrenic spectrum disorder (MINI)
• Substance abuse (heroin, cocaine, ecstasy) (MINI)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Emotion regulation	30 minutes	Emotion Regulation Skills Questionnaire (score), higher scores mean better outcome, value minimum of 0 maximum 108

Secondary Outcome Measures

Name	Time	Method
Change in Daily Emotion regulation flexibility	Immediately after the intervention	Experience sampling method using PIEL application (flexibility in emotion regulation strategies) - Questionnaire on smartphone (score aggregated with the 3 times of measurements)
Change in Depressive symptoms	20 minutes	Beck Depressive Inventory Questionnaire (BDI-II) (score), higher scores mean worse outcome, value minimum of 0 maximum 63
Change in Anxious symptoms	20 minutes	Beck Anxiety Inventory Questionnaire (BAI) (score), higher scores mean worse outcome, value minimum of 0 maximum 63

Trial Locations

Locations (1)

Université Grenoble Alpes; 🇫🇷 Grenoble, France