Anxiety Depression, Emotion Regulation
Conditions
Keywords
emotion regulation flexibility, randomized controlled trial, experience sampling method, daily measures, emotion regulation program
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.
Interventions
BEHAVIORALART
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
BEHAVIORALRelaxation
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
Sponsors
University Grenoble Alps
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Intervention model description
Treatment compared to an active control group (i.e., a relaxation program group)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Emotion regulation | 30 minutes | Emotion Regulation Skills Questionnaire (score), higher scores mean better outcome, value minimum of 0 maximum 108 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depressive symptoms | 20 minutes | Beck Depressive Inventory Questionnaire (BDI-II) (score), higher scores mean worse outcome, value minimum of 0 maximum 63 |
| Change in Anxious symptoms | 20 minutes | Beck Anxiety Inventory Questionnaire (BAI) (score), higher scores mean worse outcome, value minimum of 0 maximum 63 |
| Change in Daily Emotion regulation flexibility | Immediately after the intervention | Experience sampling method using PIEL application (flexibility in emotion regulation strategies) - Questionnaire on smartphone (score aggregated with the 3 times of measurements) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Expectancies on treatment | During the procedure | Credibility and Expectancy Questionnaire - Control in the two groups, value minimum 4, maximum 36, higher scores mean better outcome |
| Changes in treatment | During the procedure/Immediately after the intervention | Question on possible changes in psychological or drug treatment during intervention |
| Therapeutic alliance | During the procedure/Immediately after the intervention | California Psychotherapy Alliance Scale - Control in the two groups - value minimum 24, maximum 168, higher scores mean better outcome |
Countries
France
Contacts
Primary ContactCarla Nardelli, PhD student
Backup ContactCatherine Bortolon, Dr HDR
Outcome results
None listed