Emotion Regulation Clinical Trial
— REFLEXOfficial title:
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.
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) |
Country | Name | City | State |
---|---|---|---|
France | Université Grenoble Alpes | Grenoble |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble | Université Grenoble-Alpes |
France,
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
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 |
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