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

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Anxiety Depression; Emotion Regulation

Treatments: Behavioral: Relaxation; Behavioral: ART

Study type: Interventional

Funder types: Other

Identifiers

NCT05390034

2022-A00378-35

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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94 participants in 2 patient groups

ART

Experimental group

Description:

Developed by Berking and Whitley (Berking \& Whitley, 2014), this transdiagnostic program aims to improve general emotion regulation skills, and more specifically by increasing participants' emotion regulation flexibility. ART targets several skills, such as acceptance, tolerance, non-judgmental awareness, self-support, analysis of the causes of emotions and emotional modification. This intervention consists of 9 sessions (2 hours each), each of which starts with the presentation of a vicious circle for psycho-education. This vicious circle is then transformed into a virtuous circle by introducing an emotion regulation skill. Participants are invited to reflect, discuss and practice this skill. Exercises are also recommended at home, with the help of audios and a written workbook made available. All the material was translated into French for the purpose of this research.

Treatment:

Behavioral: ART

Relaxation

Active Comparator group

Description:

The relaxation group will be based mainly on the intervention developed by Dominique Servant (Relaxation and meditation, 2021), adapted for this research for the group format and divided into 9 modules (2 hours each). This intervention proposes an added psycho-education part similar to the dedicated session of the ART program, followed by the teaching of different relaxation techniques to the participants, who are invited to test them in session and then to practice them at home. This control group focuses on a specific component present in the ART group (relaxation), allowing us to assess the impact of the other components of the ART program and thus explore our flexibility hypothesis (requiring several emotion regulation skills). Note that the mindfulness meditation components were removed from the program for this study, as they were considered a second emotion regulation skill.

Treatment:

Behavioral: Relaxation