Clinical trial NCT02911207: Evaluation of Emotion Management Skill Strengthening in Chronically Ill Patients, Benefiting From Creative and Physical Activities
Official title: Evaluation of Emotion Management Skill Strengthening in Chronically Ill Patients, Benefiting From Creative and Physical Activities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotion Management Skill
Educational Therapy
Creative and Physical Activities
Keywords: chronic ill patients
Emotion management skill
Quality of Life
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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: 1. 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.
2. 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.
3. In arm 2, patients will follow the same pattern but will start activities 6 months later.
4. 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.
5. Every six months during one year, data will be collected by mail or e-mail.

Eligibility criteria: Inclusion Criteria:

* 18 years old and over
* Chronical illness
* Followed by a physician from Nantes University hospital

Exclusion Criteria:

* Having already taken part in activities within the association "La Fabrique Créative de Santé"
* Mental illness

Primary outcomes:
measure: DERS questionnaire
timeFrame: 6 months after baseline interview
Secondary outcomes:
measure: Changes in quality of life: comparison between baseline assessment and assessment 2
timeFrame: 6 months after baseline interview
measure: Changes in quality of life: comparison between baseline assessment and assessment 2
timeFrame: 6 months after baseline interview
measure: Changes in quality of life: comparison between baseline assessment and assessment 2
timeFrame: 6 months after baseline interview
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
References: