Emotion Management SkillEvAdNCT02911207
Evaluation of Emotion Management Skill Strengthening in Chronically Ill Patients, Benefiting From Creative and Physical Activities
A study testing patients choose one creative activity and one physical activity in people with Emotion Management Skill and Educational Therapy, run by Nantes University Hospital at 1 site in France.
Trial summary
There are very few studies on emotion management in chronically ill patients. They usually include small sample size (less than 30 persons) and are not randomized controlled trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotion Management Skill, Educational Therapy, Creative and Physical Activities
- What is being tested?
- patients choose one creative activity and one physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 29 Aug 2016to 4 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and over
- Chronical illness
- Followed by a physician from Nantes University hospital
Who cannot join
- Having already taken part in activities within the association "La Fabrique Créative de Santé"
- Mental illness
Trial locations and contacts
1 site in 1 country.
About this study
There are very few studies on emotion management in chronically ill patients. They usually include small sample size (less than 30 persons) and are not randomized controlled trials. However, emotion management is an essential coping skill in mental well-being and quality of life and is the subject of numerous studies in psychology.The investigators hypothesized that a creative and physical activities combination in chronically ill will promote the strengthening of emotion management skill. The investigators will conduct an innovating study combining quantitative and qualitative variables in a randomized controlled trial to confirm our hypothesis.
Read the detailed description
- Surveyors will conduct a first interview with patients (within an association "La Fabrique Créative de Santé" that provides free activities to chronically ill) , in order to collect data on emotion management and quality of life perception and to assess expectations regarding the activities. At the end of the interview, patients will be randomized in two groups.
- In arm 1, patients choose one creative activity (evolutive art-therapy, writing workshop, theatre, singing) and one physical activity (pilates, mindfulness meditation, shiatsu, ayurvedic massage) that they will practice during the following six months.
- In arm 2, patients will follow the same pattern but will start activities 6 months later.
- After 6 months data on patients emotion management and quality of life perception will be collected again and interviews will be conducted regarding their overall satisfaction of the activities.
- Every six months during one year, data will be collected by mail or e-mail.
- Being tested
- patients choose one creative activity and one physical activity
- Keywords
- chronic ill patients, Emotion management skill, Quality of Life
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients choose one creative activity and one physical activityBehavioural
taking part in 2 activities (a creative one and a physical one)
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | patients choose one creative activity (evolutive art-therapy, writing workshop, theatre, singing) and one physical activity (pilates, mindfulness meditation, shiatsu, ayurvedic massage) that they will practice during the following six months Receives: Behavioral: patients choose one creative activity and one physical activity |
| control arm | Active comparator | patients choose one creative activity (evolutive art-therapy, writing workshop, theatre, singing) and one physical activity (pilates, mindfulness meditation, shiatsu, ayurvedic massage) that they will practice during six months but they will start 6 months later after randomization Receives: Behavioral: patients choose one creative activity and one physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
DERS questionnaire
differences between initial and final answers (after 6 months of intervention) scale composed of 36 items in 6 dimensions
Measured: 6 months after baseline interview
Secondary outcomes (3)
Changes in quality of life: comparison between baseline assessment and assessment 2
With following scale of quality of life: SeiQoL
Measured: 6 months after baseline interview
Changes in quality of life: comparison between baseline assessment and assessment 2
With following scale of quality of life: EQ5D
Measured: 6 months after baseline interview
Changes in quality of life: comparison between baseline assessment and assessment 2
With following scale of quality of life: WHOQoL
Measured: 6 months after baseline interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start29 Aug 2016
- Primary completion4 Dec 2018
- Study completion4 Dec 2018
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 Management SkillStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911207
- Sponsor's protocol ID
- RC16_0011
- Acronym
- EvAd
- Status last verified
- Jun 2021
- First submitted
- 25 Aug 2016
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Le Rhun A, Caillet P, Lebeaupin M, Duval M, Guilmault L, Anthoine E, Borghi G, Leclere B, Moret L. Mind-body and art therapies impact on emotional regulation in patients with chronic diseases: a pragmatic mixed-methods randomized controlled trial. BMC Complement Med Ther. 2023 Sep 28;23(1):344. doi: 10.1186/s12906-023-04173-8.
PubMed 37770881
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Emotion Management Skill Strengthening in Chronically Ill Patients, Benefiting From Creative and Physical Activities
- ClinicalTrials.gov ID
- NCT02911207
- Acronym / sponsor ID
- EvAd / RC16_0011
- Keywords
- chronic ill patients, Emotion management skill, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 29 Aug 2016 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 22 Sep 2016 (estimated)
- 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.
There are very few studies on emotion management in chronically ill patients. They usually include small sample size (less than 30 persons) and are not randomized controlled trials. However, emotion management is an essential coping skill in mental well-being and quality of life and is the subject of numerous studies in psychology.The investigators hypothesized that a creative and physical activities combination in chronically ill will promote the strengthening of emotion management skill. The investigators will conduct an innovating study combining quantitative and qualitative variables in a randomized controlled trial to confirm our hypothesis.
Detailed description
- Surveyors will conduct a first interview with patients (within an association "La Fabrique Créative de Santé" that provides free activities to chronically ill) , in order to collect data on emotion management and quality of life perception and to assess expectations regarding the activities. At the end of the interview, patients will be randomized in two groups.
- In arm 1, patients choose one creative activity (evolutive art-therapy, writing workshop, theatre, singing) and one physical activity (pilates, mindfulness meditation, shiatsu, ayurvedic massage) that they will practice during the following six months.
- In arm 2, patients will follow the same pattern but will start activities 6 months later.
- After 6 months data on patients emotion management and quality of life perception will be collected again and interviews will be conducted regarding their overall satisfaction of the activities.
- Every six months during one year, data will be collected by mail or e-mail.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: patients choose one creative activity and one physical activitypatients choose one creative activity (evolutive art-therapy, writing workshop, theatre, singing) and one physical activity (pilates, mindfulness meditation, shiatsu, ayurvedic massage) that they will practice during the following six months |
| control arm | Active comparator | Behavioral: patients choose one creative activity and one physical activitypatients choose one creative activity (evolutive art-therapy, writing workshop, theatre, singing) and one physical activity (pilates, mindfulness meditation, shiatsu, ayurvedic massage) that they will practice during six months but they will start 6 months later after randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old and over
- Chronical illness
- Followed by a physician from Nantes University hospital
Key exclusion criteria (2 listed)
- Having already taken part in activities within the association "La Fabrique Créative de Santé"
- Mental illness
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 |
|---|---|---|
| patients choose one creative activity and one physical activitytaking part in 2 activities (a creative one and a physical one) | Behavioural | Intervention arm, control arm |
Primary outcome
DERS questionnaire
Time frame: 6 months after baseline interview
differences between initial and final answers (after 6 months of intervention) scale composed of 36 items in 6 dimensions
3 secondary outcomes
Changes in quality of life: comparison between baseline assessment and assessment 2
Time frame: 6 months after baseline interview
Changes in quality of life: comparison between baseline assessment and assessment 2
Time frame: 6 months after baseline interview
Changes in quality of life: comparison between baseline assessment and assessment 2
Time frame: 6 months after baseline interview
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 37770881Le Rhun A, Caillet P, Lebeaupin M, Duval M, Guilmault L, Anthoine E, Borghi G, Leclere B, Moret L. Mind-body and art therapies impact on emotional regulation in patients with chronic diseases: a pragmatic mixed-methods randomized controlled trial. BMC Complement Med Ther. 2023 Sep 28;23(1):344. doi: 10.1186/s12906-023-04173-8.
- Individual participant dataSharing planned: No
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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 patients choose one creative activity and one physical activity in people with Emotion Management Skill and Educational Therapy, run by Nantes University Hospital 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 14 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
DERS questionnaire (time frame: 6 months after baseline interview). 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 NCT02911207, 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 14 Sep 2026.