Emotion RegulationINTRECNCT05113680
Process Evaluation of the Effectiveness of Two Transdiagnostic Interventions on Emotion Regulation
A study testing compassion focused group and emotional competencies in people with Emotion Regulation, run by University Grenoble Alps at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation
- What is being tested?
- compassion focused group and emotional competencies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2021to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Process Evaluation of the Effectiveness of Two Transdiagnostic Interventions on Emotion Regulation : Compassion Focused Program and Emotion Competence Training Program
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.
Read the 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
- Being tested
- compassion focused group, emotional competencies
- Keywords
- compassion, emotion regulation, emotional competencies, transdiagnostic
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compassion focused groupBehavioural
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 competenciesBehavioural
Emotional competencies group focused on identification, comprehension, expression, regulation, utilization. practices : TCC, cognitive restructuring, and mindfulness 12 sessions of 2h each
| Study group | Role | What they receive |
|---|---|---|
| compassion | Experimental | compassion focused group based on CFT Receives: Behavioral: compassion focused group |
| emotional competencies | Active comparator | emotional competencies group (based on emotional intelligence) Receives: Behavioral: emotional competencies |
| control | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1week
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 1week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start3 Mar 2021
- Primary completion15 May 2022
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- compassion focused group, emotional competencies group, control group
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Grenoble Alps
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marine Paucsik, University Grenoble Alps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113680
- Sponsor's protocol ID
- UGrenobleAlps
- Acronym
- INTREC
- Status last verified
- May 2022
- First submitted
- 20 Sep 2021
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Paucsik M, Baeyens C, Tessier D, Shankland R. Reducing emotion dysregulation online in nonclinical population with compassion focused therapy and emotional competencies program: A randomized controlled trial. J Clin Psychol. 2024 Dec;80(12):2405-2433. doi: 10.1002/jclp.23748. Epub 2024 Oct 29.
PubMed 39471329
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Process Evaluation of the Effectiveness of Two Transdiagnostic Interventions on Emotion Regulation : Compassion Focused Program and Emotion Competence Training Program
- ClinicalTrials.gov ID
- NCT05113680
- Acronym / sponsor ID
- INTREC / UGrenobleAlps
- Conditions
- Emotion Regulation
- Keywords
- compassion, emotion regulation, emotional competencies, transdiagnostic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (actual)
- Lead sponsor
- University Grenoble AlpsUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- compassion focused group, emotional competencies group, control group
| Arm | Type | Receives |
|---|---|---|
| compassion | Experimental | Behavioral: compassion focused groupcompassion focused group based on CFT |
| emotional competencies | Active comparator | Behavioral: emotional competenciesemotional competencies group (based on emotional intelligence) |
| control | No intervention | –control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| compassion focused groupBased on compassion focused therapy (CFT) principles practices : soothing breathing rythm, compassionate-self, compassion for shame and self-criticism 12 sessions of 2h each | Behavioural | compassion |
| emotional competenciesEmotional competencies group focused on identification, comprehension, expression, regulation, utilization. practices : TCC, cognitive restructuring, and mindfulness 12 sessions of 2h each | Behavioural | emotional competencies |
Primary outcome
Difficulty in Emotion regulation Scale (DERS, Gratz & Roemer, 2004
Time frame: 1week
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.
4 secondary outcomes
Depression, Anxiety and Stress Scale (DASS21, Henry & Crawford, 2005
Time frame: 1week
Well being scale (PWB; Ryff, 1995)
Time frame: 1week
Self-compassion Short Form Scale (SCS-SF; Neff, 2003)
Time frame: 1week
Profile of Emotional Competence (PEC, Mikolajczak, Brasseur, & Fantini-Hauwel, 2014)
Time frame: 1week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Derived from this study: PubMed 39471329Paucsik M, Baeyens C, Tessier D, Shankland R. Reducing emotion dysregulation online in nonclinical population with compassion focused therapy and emotional competencies program: A randomized controlled trial. J Clin Psychol. 2024 Dec;80(12):2405-2433. doi: 10.1002/jclp.23748. Epub 2024 Oct 29.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing compassion focused group and emotional competencies in people with Emotion Regulation, run by University Grenoble Alps at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulty in Emotion regulation Scale (DERS, Gratz & Roemer, 2004 (time frame: 1week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05113680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.