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

NCT ID: NCT05113680

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-03
• Study Completion Date: 2022-12-15

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

Conditions

Emotion Regulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

compassion

compassion focused group based on CFT

Group Type: EXPERIMENTAL

compassion focused group

Intervention Type: 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

emotional competencies

emotional competencies group (based on emotional intelligence)

Group Type: ACTIVE_COMPARATOR

emotional competencies

Intervention Type: BEHAVIORAL

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

control

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

compassion focused group

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

Intervention Type: BEHAVIORAL

emotional competencies

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Grenoble Alps

OTHER

Sponsor Role: lead

Responsible Party

Marine Paucsik

Clinical PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marine Paucsik

Grenoble, Isere, France

Countries

France

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

UGrenobleAlps

Identifier Type: -

Identifier Source: org_study_id