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

Primary Purpose

Anxiety Depression, Emotion Regulation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ART
Relaxation
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Depression focused on measuring emotion regulation flexibility, randomized controlled trial, experience sampling method, daily measures, emotion regulation program

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Université Grenoble AlpesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ART

Relaxation

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Depressive symptoms
Beck Depressive Inventory Questionnaire (BDI-II) (score), higher scores mean worse outcome, value minimum of 0 maximum 63
Change in Anxious symptoms
Beck Anxiety Inventory Questionnaire (BAI) (score), higher scores mean worse outcome, value minimum of 0 maximum 63
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)

Full Information

First Posted
March 17, 2022
Last Updated
November 2, 2022
Sponsor
University Hospital, Grenoble
Collaborators
Université Grenoble-Alpes
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1. Study Identification

Unique Protocol Identification Number
NCT05390034
Brief Title
Improving Emotion Regulation Flexibility: Testing the Efficacy of an Emotion Regulation Program in College Students
Acronym
REFLEX
Official Title
REFLEX: A Randomized Controlled Trial to Test the Efficacy of an Emotion Regulation Flexibility Program With Daily Measures
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Université Grenoble-Alpes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Depression, Emotion Regulation
Keywords
emotion regulation flexibility, randomized controlled trial, experience sampling method, daily measures, emotion regulation program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Treatment compared to an active control group (i.e., a relaxation program group)
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ART
Arm Type
Experimental
Arm 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.
Arm Title
Relaxation
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
ART
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Relaxation
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Emotion regulation
Description
Emotion Regulation Skills Questionnaire (score), higher scores mean better outcome, value minimum of 0 maximum 108
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Change in Depressive symptoms
Description
Beck Depressive Inventory Questionnaire (BDI-II) (score), higher scores mean worse outcome, value minimum of 0 maximum 63
Time Frame
20 minutes
Title
Change in Anxious symptoms
Description
Beck Anxiety Inventory Questionnaire (BAI) (score), higher scores mean worse outcome, value minimum of 0 maximum 63
Time Frame
20 minutes
Title
Change in Daily Emotion regulation flexibility
Description
Experience sampling method using PIEL application (flexibility in emotion regulation strategies) - Questionnaire on smartphone (score aggregated with the 3 times of measurements)
Time Frame
Immediately after the intervention
Other Pre-specified Outcome Measures:
Title
Therapeutic alliance
Description
California Psychotherapy Alliance Scale - Control in the two groups - value minimum 24, maximum 168, higher scores mean better outcome
Time Frame
During the procedure/Immediately after the intervention
Title
Expectancies on treatment
Description
Credibility and Expectancy Questionnaire - Control in the two groups, value minimum 4, maximum 36, higher scores mean better outcome
Time Frame
During the procedure
Title
Changes in treatment
Description
Question on possible changes in psychological or drug treatment during intervention
Time Frame
During the procedure/Immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carla Nardelli, PhD student
Phone
+33682830595
Email
carla.nardelli@univ-grenoble-alpes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Bortolon, Dr HDR
Email
catherine.bortolon@univ-grenoble-alpes.fr
Facility Information:
Facility Name
Université Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla Nardelli, PhD Student
Phone
+33682830595
Email
carla.nardelli@univ-grenoble-alpes.fr
First Name & Middle Initial & Last Name & Degree
Catherine Bortolon, DR
Email
catherine.bortolon@univ-grenoble-alpes.fr
First Name & Middle Initial & Last Name & Degree
Jérome Holtzmann, Dr
First Name & Middle Initial & Last Name & Degree
Catherine Bortolon, Dr
First Name & Middle Initial & Last Name & Degree
Céline Baeyens, Pr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Theoretical background, objectives, hypothesis, expected results, methodology
IPD Sharing Time Frame
3 years
IPD Sharing URL
http://osf.io/28xh6/
Citations:
PubMed Identifier
31465443
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.
Results Reference
result
PubMed Identifier
22659159
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.
Results Reference
result
PubMed Identifier
20015584
Citation
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.
Results Reference
result
PubMed Identifier
3655778
Citation
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.
Results Reference
result
PubMed Identifier
12212647
Citation
Gross JJ. Emotion regulation: affective, cognitive, and social consequences. Psychophysiology. 2002 May;39(3):281-91. doi: 10.1017/s0048577201393198.
Results Reference
result
PubMed Identifier
17716046
Citation
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.
Results Reference
result

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

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