Process Evaluation of the Effectiveness of Two Transdiagnostic Interventions on Emotion Regulation

Study Overview
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Brief Summary
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Emotional regulation (ER) appears today as a fundamental skill for the adaptation of an individual to his environment. Indeed, functional and efficient ER is crucial for mental well-being, but also for physical health, for the maintenance of satisfying social relationships , and for work performance. Many research studies have shown that difficulties with ER are central to the development of many mental disorders. Consequently, this skill can be the target of psychological interventions , the effectiveness of which can be tested as well as the mechanisms underlying that effectiveness. Various mechanisms of effectiveness have been advanced in the literature. Of these, this project will specifically test cognitive flexibility and feelings of self-efficacy. Although a growing number of interventions attempt to target emotional regulation, few are evaluated in subclinical populations and few are protocolized. Similarly, there is little research evaluating the effectiveness processes of these interventions. To date, two types of interventions show particular promise: emotion competence based interventions and compassion focused therapy. This research will therefore be based on the evaluation of two interventions in a randomized controlled trial: Emotion Competence Training Program and Compassion Focused Program that will take place over 12 two-hour sessions in a subclinical and clinical population.

Detailed Description
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This study is composed: a single case study in a subclinical population a randomized controlled study in a subclinical population a pilot study in a clinical population

Official Title
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Process Evaluation of the Effectiveness of Two Transdiagnostic Interventions on Emotion Regulation : Compassion Focused Program and Emotion Competence Training Program

Conditions
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Emotion Regulation

Intervention / Treatment
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* Behavioral: compassion focused group
* Behavioral: emotional competencies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 65 inclusive Person who can understand, speak and read French Person who has been orally informed and has given informed consent to participate in the study Affiliated with a social security plan Exclusion Criteria: Score greater than or equal to 14 on the DASS21 scale. Current participation in another study regarding emotional regulation Participation in positive psychology, mindfulness, or stress management groups for less than 3 months Change in psychotropic medication (taking, stopping, or changing dosage) within 2 months prior to study participation Substance use Person with an intellectual disability. Person deprived of liberty by judicial decision.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: compassion focused group, emotional competencies group, control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: compassion<br>compassion focused group based on CFT | Behavioral: compassion focused group<br>* Based on compassion focused therapy (CFT) principles practices : soothing breathing rythm, compassionate-self, compassion for shame and self-criticism 12 sessions of 2h each<br>|
| Active Comparator: emotional competencies<br>emotional competencies group (based on emotional intelligence) | Behavioral: emotional competencies<br>* Emotional competencies group focused on identification, comprehension, expression, regulation, utilization. practices : TCC, cognitive restructuring, and mindfulness 12 sessions of 2h each<br>|
| No Intervention: control<br>control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difficulty in Emotion regulation Scale (DERS, Gratz & Roemer, 2004 | The DERS-SF is an 18-item self-report multidimensional scale of emotional regulation skills. The DERS examines six difficulties in emotion regulation: (1) unacceptance of negative emotions, (2) difficulty engaging in goal-directed behaviors in the presence of negative emotions, (3) difficulty controlling impulsive behavior in the presence of negative emotions, (4) limited access to emotion regulation strategies perceived as effective, (5) lack of emotional awareness, and (6) lack of understanding of one's emotions, defined as lack of emotional clarity. Items are scored on a five-point Likert scale. Higher scores indicate the presence of difficulties in emotion regulation. Maximum values is 90 and minimum is 18. | 1week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression, Anxiety and Stress Scale (DASS21, Henry & Crawford, 2005 | The DASS-21 is a self-administered questionnaire that measures the severity of depression (e.g., I couldn't seem to feel anything positive), anxiety (e.g., I worried about situations in which I might panic and make a fool of myself), and stress (e.g., I had trouble calming down) during the past week. Each item is scored from 0 (did not apply to me at all in the past week) to 3 (applied to me very often or most of the time in the past week). Higher scores indicate the presence of symptom of depression, anxiety and stress. Maximum values is 84 and minimum is 21. | 1week | 
| Well being scale (PWB; Ryff, 1995) | The Psychological Well-Being Scale measures six sub-dimensions of well-being: self-acceptance (a positive attitude toward oneself and others), positive relationships with others (warm, trusting and satisfying relationships), autonomy (independence, ability to follow one's own norms, and resist social pressures), environmental mastery (competence in dealing with the demands of life), life purpose (sense of meaning, goals and direction), and self-fulfillment (openness to new experiences, view of oneself as developing and growing). Higher scores indicate the presence of well being. Maximum values is 108 and minimum is 18. We used the 18-item version (3 items per dimension) which is parsimonious and retains good psychometric properties (Ryff & Keyes, 1995). | 1week | 
| Self-compassion Short Form Scale (SCS-SF; Neff, 2003) | SCS-SF is a 12-item instrument with six subscales assessing elements of self-compassion (i.e., self-kindness, self-judgment, common humanity, isolation, mindfulness, and overidentification). Maximum values is 75 and minimum is 12. The higher the score, the higher the level of self-compassion | 1week | 
| Profile of Emotional Competence (PEC, Mikolajczak, Brasseur, & Fantini-Hauwel, 2014) | The Emotional Competence Scale is a multidimensional self-assessment scale. It assesses the five fundamental emotional competencies (identification, understanding, expression, regulation, and use of emotions) separately for one's own emotions and the emotions of others. This scale is composed of 50 items (Mikolajczak et al., 2014). Maximum values is 250 and minimum is 50.The higher the scores, the higher the level of emotional competence. | 1week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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compassion, emotion regulation, emotional competencies, transdiagnostic