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

REFLEX: A Randomized Controlled Trial to Test the Efficacy of an Emotion Regulation Flexibility Program With Daily Measures

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety Depression; Emotion Regulation
• Intervention / Treatment: Behavioral: ART; Behavioral: Relaxation

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 Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carla Nardelli, PhD Student; Phone Number: +33682830595; Email: carla.nardelli@univ-grenoble-alpes.fr
• Study Contact Backup: Name: Catherine Bortolon, Dr HDR; Email: catherine.bortolon@univ-grenoble-alpes.fr

Study Locations

• France
  • Grenoble, France, 38400
    • Recruiting
    • Université Grenoble Alpes
    • Contact: Carla Nardelli, PhD Student; Phone Number: +33682830595; Email: carla.nardelli@univ-grenoble-alpes.fr
    • Contact: Catherine Bortolon, DR; Email: catherine.bortolon@univ-grenoble-alpes.fr
    • Principal Investigator: Jérome Holtzmann, Dr
    • Sub-Investigator: Catherine Bortolon, Dr
    • Sub-Investigator: Céline Baeyens, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ART; 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.	Behavioral: ART; Session 1: Description of the group & Psychoeducation Session 2: Breathing and muscle relaxation Session 3: Importance of practice/motivation Session 4: Nonjudgemental awareness Session 5: Acceptance and tolerance Session 6: Self-support Session 7: Analysis of emotions Session 8: Modification of emotions Session 9: Practice and contextual applications + end of group
Active Comparator: Relaxation; 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.	Behavioral: Relaxation; Session 1: Description of the groupe & Psychoeducation Session 2: Breathing control 1 Session 3: Breathing control 2 Session 4: Muscle relaxation Session 5: Visualisation Session 6: Stretching Session 7: Schultz relaxation Session 8: Schultz relaxation Session 9: Summary and end of group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic alliance	California Psychotherapy Alliance Scale - Control in the two groups - value minimum 24, maximum 168, higher scores mean better outcome	During the procedure/Immediately after the intervention
Expectancies on treatment	Credibility and Expectancy Questionnaire - Control in the two groups, value minimum 4, maximum 36, higher scores mean better outcome	During the procedure
Changes in treatment	Question on possible changes in psychological or drug treatment during intervention	During the procedure/Immediately after the intervention

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Université Grenoble-Alpes

Publications and helpful links

General Publications

• Berking M, Eichler E, Luhmann M, Diedrich A, Hiller W, Rief W. Affect regulation training reduces symptom severity in depression - A randomized controlled trial. PLoS One. 2019 Aug 29;14(8):e0220436. doi: 10.1371/journal.pone.0220436. eCollection 2019.
• Aldao A, Nolen-Hoeksema S. The influence of context on the implementation of adaptive emotion regulation strategies. Behav Res Ther. 2012 Aug;50(7-8):493-501. doi: 10.1016/j.brat.2012.04.004. Epub 2012 May 7.
• Aldao A, Nolen-Hoeksema S, Schweizer S. Emotion-regulation strategies across psychopathology: A meta-analytic review. Clin Psychol Rev. 2010 Mar;30(2):217-37. doi: 10.1016/j.cpr.2009.11.004. Epub 2009 Nov 20.
• Csikszentmihalyi M, Larson R. Validity and reliability of the Experience-Sampling Method. J Nerv Ment Dis. 1987 Sep;175(9):526-36. doi: 10.1097/00005053-198709000-00004.
• Gross JJ. Emotion regulation: affective, cognitive, and social consequences. Psychophysiology. 2002 May;39(3):281-91. doi: 10.1017/s0048577201393198.
• Kazdin AE. Mediators and mechanisms of change in psychotherapy research. Annu Rev Clin Psychol. 2007;3:1-27. doi: 10.1146/annurev.clinpsy.3.022806.091432.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): September 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: randomized controlled trial; experience sampling method; emotion regulation flexibility; daily measures; emotion regulation program
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2022-A00378-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Theoretical background, objectives, hypothesis, expected results, methodology
• IPD Sharing Time Frame: 3 years
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No