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

NCT05113680 | Unknown DMC

• 1 other identifier: UGrenobleAlps
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotion Regulation

Keywords

compassion; emotion regulation; emotional competencies; transdiagnostic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Depression, Anxiety and Stress Scale (DASS21, Henry & Crawford, 2005

  1week

• Well being scale (PWB; Ryff, 1995)

  1week

• Self-compassion Short Form Scale (SCS-SF; Neff, 2003)

  1week

• Profile of Emotional Competence (PEC, Mikolajczak, Brasseur, & Fantini-Hauwel, 2014)

  1week

Other Outcomes (2)

• Belief and expectation about therapy (QCA, Coste, Tarquinio, Rouquette, Montel, & Pouchot, 2019)

  1week

• Satisfaction about therapy and therapist (STTS-R, Oei & Green, 2008)

  12week

Study Arms (3)

compassion

EXPERIMENTAL

compassion focused group based on CFT

Behavioral: compassion focused group

emotional competencies

ACTIVE COMPARATOR

emotional competencies group (based on emotional intelligence)

Behavioral: emotional competencies

control

NO INTERVENTION

control group

Interventions

compassion focused group BEHAVIORAL

Based on compassion focused therapy (CFT) principles practices : soothing breathing rythm, compassionate-self, compassion for shame and self-criticism 12 sessions of 2h each

compassion

emotional competencies BEHAVIORAL

Emotional competencies group focused on identification, comprehension, expression, regulation, utilization. practices : TCC, cognitive restructuring, and mindfulness 12 sessions of 2h each

emotional competencies

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Grenoble Alps: lead

Study Sites (1)

Marine Paucsik

Grenoble, Isere, 38000, France

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical PhD Student

Model Details: compassion focused group, emotional competencies group, control group

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: November 9, 2021
• Study Start: March 3, 2021
• Primary Completion: May 15, 2022
• Study Completion: December 15, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

FR (1)