Clinical trial NCT05390034: Improving Emotion Regulation Flexibility: Testing the Efficacy of an Emotion Regulation Program in College Students
Official title: REFLEX: A Randomized Controlled Trial to Test the Efficacy of an Emotion Regulation Flexibility Program With Daily Measures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Depression
Emotion Regulation
Keywords: emotion regulation flexibility
randomized controlled trial
experience sampling method
daily measures
emotion regulation program
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: University Grenoble Alps
First posted: 2022-05-25
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment compared to an active control group (i.e., a relaxation program group)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Emotion regulation
timeFrame: 30 minutes
Secondary outcomes:
measure: Change in Depressive symptoms
timeFrame: 20 minutes
measure: Change in Anxious symptoms
timeFrame: 20 minutes
measure: Change in Daily Emotion regulation flexibility
timeFrame: Immediately after the intervention
Other outcomes:
measure: Therapeutic alliance
timeFrame: During the procedure/Immediately after the intervention
measure: Expectancies on treatment
timeFrame: During the procedure
measure: Changes in treatment
timeFrame: During the procedure/Immediately after the intervention
Locations:
city: Grenoble
country: France
facility: Université Grenoble Alpes
Study officials:
References:
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