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

Emotion Regulation Clinical Trial

— REFLEX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05390034
• Other study ID #: 2022-A00378-35
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2022
• Source: University Hospital, Grenoble
• Contact: Carla Nardelli, PhD student
• Phone: +33682830595
• Email: carla.nardelli[@]univ-grenoble-alpes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Depression
• Depression
• Emotion Regulation

Intervention

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
• 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

Locations

Country	Name	City	State
France	Université Grenoble Alpes	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Université Grenoble-Alpes

Country where clinical trial is conducted

France, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

Csikszentmihalyi M, Larson R. Validity and reliability of the Experience-Sampling Method. J Nerv Ment Dis. 1987 Sep;175(9):526-36. — View Citation

Gross JJ. Emotion regulation: affective, cognitive, and social consequences. Psychophysiology. 2002 May;39(3):281-91. Review. — View Citation

Kazdin AE. Mediators and mechanisms of change in psychotherapy research. Annu Rev Clin Psychol. 2007;3:1-27. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Changes in treatment	Question on possible changes in psychological or drug treatment during intervention	During the procedure/Immediately after the intervention
Primary	Change in Emotion regulation	Emotion Regulation Skills Questionnaire (score), higher scores mean better outcome, value minimum of 0 maximum 108	30 minutes
Secondary	Change in Depressive symptoms	Beck Depressive Inventory Questionnaire (BDI-II) (score), higher scores mean worse outcome, value minimum of 0 maximum 63	20 minutes
Secondary	Change in Anxious symptoms	Beck Anxiety Inventory Questionnaire (BAI) (score), higher scores mean worse outcome, value minimum of 0 maximum 63	20 minutes
Secondary	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