Clinical trial NCT05113680: Process Evaluation of the Effectiveness of Two Transdiagnostic Interventions on Emotion Regulation
Official title: Process Evaluation of the Effectiveness of Two Transdiagnostic Interventions on Emotion Regulation : Compassion Focused Program and Emotion Competence Training Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotion Regulation
Keywords: compassion
emotion regulation
emotional competencies
transdiagnostic
Lead sponsor: University Grenoble Alps
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: compassion focused group, emotional competencies group, control group
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Difficulty in Emotion regulation Scale (DERS, Gratz & Roemer, 2004
timeFrame: 1week
Secondary outcomes:
measure: Depression, Anxiety and Stress Scale (DASS21, Henry & Crawford, 2005
timeFrame: 1week
measure: Well being scale (PWB; Ryff, 1995)
timeFrame: 1week
measure: Self-compassion Short Form Scale (SCS-SF; Neff, 2003)
timeFrame: 1week
measure: Profile of Emotional Competence (PEC, Mikolajczak, Brasseur, & Fantini-Hauwel, 2014)
timeFrame: 1week
Other outcomes:
measure: Belief and expectation about therapy (QCA, Coste, Tarquinio, Rouquette, Montel, & Pouchot, 2019)
timeFrame: 1week
measure: Satisfaction about therapy and therapist (STTS-R, Oei & Green, 2008)
timeFrame: 12week
Locations:
city: Grenoble
country: France
facility: Marine Paucsik
state: Isere
Study officials:
References: