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

NCT05390034 | Unknown

• 1 other identifier: 2022-A00378-35
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Depression; Emotion Regulation

Keywords

emotion regulation flexibility; randomized controlled trial; experience sampling method; daily measures; emotion regulation program

Outcome Measures

Primary Outcomes (1)

• Change in Emotion regulation

  Emotion Regulation Skills Questionnaire (score), higher scores mean better outcome, value minimum of 0 maximum 108

  30 minutes

Secondary Outcomes (3)

• Change in Depressive symptoms

  20 minutes

• Change in Anxious symptoms

  20 minutes

• Change in Daily Emotion regulation flexibility

  Immediately after the intervention

Other Outcomes (3)

• Therapeutic alliance

  During the procedure/Immediately after the intervention

• Expectancies on treatment

  During the procedure

• Changes in treatment

  During the procedure/Immediately after the intervention

Study Arms (2)

ART

EXPERIMENTAL

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

Relaxation

ACTIVE COMPARATOR

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

Interventions

ART BEHAVIORAL

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

ART

Relaxation BEHAVIORAL

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

Relaxation

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• University Grenoble Alps: collaborator

Study Sites (1)

Université Grenoble Alpes

Grenoble, 38400, France

RECRUITING

Related Publications (6)

• 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.

  PMID: 31465443 RESULT

• 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.

  PMID: 22659159 RESULT

• 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.

  PMID: 20015584 RESULT

• 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.

  PMID: 3655778 RESULT

• Gross JJ. Emotion regulation: affective, cognitive, and social consequences. Psychophysiology. 2002 May;39(3):281-91. doi: 10.1017/s0048577201393198.

  PMID: 12212647 RESULT

• 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.

  PMID: 17716046 RESULT

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Central Study Contacts

Carla Nardelli, PhD student

CONTACT

+33682830595; carla.nardelli@univ-grenoble-alpes.fr

Catherine Bortolon, Dr HDR

CONTACT

catherine.bortolon@univ-grenoble-alpes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomized to one of the two arms (i.e., ART program or active control group). Outcomes assessments will be performed with online questionnaires.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment compared to an active control group (i.e., a relaxation program group)

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: May 25, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2023
• Last Updated: November 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 3 years

Locations

FR (1)