Anxiety DepressionREFLEXNCT05390034
Improving Emotion Regulation Flexibility: Testing the Efficacy of an Emotion Regulation Program in College Students
A study testing ART and Relaxation in people with Anxiety Depression and Emotion Regulation, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Depression, Emotion Regulation
- What is being tested?
- ART and Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 15Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Catherine Bortolon, Dr HDR contact
France1 site, 1 recruiting
- Recruiting
Université Grenoble Alpes
Grenoble, 38400
Carla Nardelli, PhD Student, +33682830595, carla.nardelli@univ-grenoble-alpes.fr
Catherine Bortolon, DR, catherine.bortolon@univ-grenoble-alpes.fr
About this study
Official 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.
Read the 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.
- Conditions
- Anxiety Depression, Emotion Regulation
- Being tested
- ART, Relaxation
- Keywords
- emotion regulation flexibility, randomized controlled trial, experience sampling method, daily measures, emotion regulation program
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTBehavioural
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
RelaxationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Emotion regulation
Emotion Regulation Skills Questionnaire (score), higher scores mean better outcome, value minimum of 0 maximum 108
Measured: 30 minutes
Secondary outcomes (3)
Change in Depressive symptoms
Beck Depressive Inventory Questionnaire (BDI-II) (score), higher scores mean worse outcome, value minimum of 0 maximum 63
Measured: 20 minutes
Change in Anxious symptoms
Beck Anxiety Inventory Questionnaire (BAI) (score), higher scores mean worse outcome, value minimum of 0 maximum 63
Measured: 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)
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Sep 2022
- Primary completion1 Sep 2022
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anxiety DepressionStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment compared to an active control group (i.e., a relaxation program group)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Grenoble Alps
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390034
- Sponsor's protocol ID
- 2022-A00378-35
- Acronym
- REFLEX
- Status last verified
- Mar 2022
- First submitted
- 17 Mar 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Theoretical background, objectives, hypothesis, expected results, methodology
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.
PubMed 31465443Aldao 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.
PubMed 22659159Aldao 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.
PubMed 20015584Csikszentmihalyi 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.
PubMed 3655778Gross JJ. Emotion regulation: affective, cognitive, and social consequences. Psychophysiology. 2002 May;39(3):281-91. doi: 10.1017/s0048577201393198.
PubMed 12212647Kazdin 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.
PubMed 17716046
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REFLEX: A Randomized Controlled Trial to Test the Efficacy of an Emotion Regulation Flexibility Program With Daily Measures
- ClinicalTrials.gov ID
- NCT05390034
- Acronym / sponsor ID
- REFLEX / 2022-A00378-35
- Conditions
- Anxiety Depression, Emotion Regulation
- Keywords
- emotion regulation flexibility, randomized controlled trial, experience sampling method, daily measures, emotion regulation program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Grenoble Alps
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Treatment compared to an active control group (i.e., a relaxation program group)
| Arm | Type | Receives |
|---|---|---|
| ART | Experimental | Behavioral: ARTDeveloped 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. |
| Relaxation | Active comparator | Behavioral: RelaxationThe 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARTSession 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 | Behavioural | ART |
| RelaxationSession 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 | Behavioural | Relaxation |
Primary outcome
Change in Emotion regulation
Time frame: 30 minutes
Emotion Regulation Skills Questionnaire (score), higher scores mean better outcome, value minimum of 0 maximum 108
3 secondary outcomes
Change in Depressive symptoms
Time frame: 20 minutes
Change in Anxious symptoms
Time frame: 20 minutes
Change in Daily Emotion regulation flexibility
Time frame: Immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Results publication: PubMed 31465443Berking 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 publication: PubMed 22659159Aldao 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 publication: PubMed 20015584Aldao 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 publication: PubMed 3655778Csikszentmihalyi 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 publication: PubMed 12212647Gross JJ. Emotion regulation: affective, cognitive, and social consequences. Psychophysiology. 2002 May;39(3):281-91. doi: 10.1017/s0048577201393198.
- Results publication: PubMed 17716046Kazdin 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.
- Individual participant dataSharing planned: Yes. Theoretical background, objectives, hypothesis, expected results, methodology
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Bortolon, Dr HDR contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ART and Relaxation in people with Anxiety Depression and Emotion Regulation, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carla Nardelli, PhD student (+33682830595, carla.nardelli@univ-grenoble-alpes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Emotion regulation (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05390034, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.