Evaluation of Emotion Management Skill Strengthening in Chronically Ill Patients, Benefiting From Creative and Physical Activities (EvAd)

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.

Study Overview

• Status: Completed
• Conditions: Emotion Management Skill; Educational Therapy; Creative and Physical Activities
• Intervention / Treatment: Behavioral: patients choose one creative activity and one physical activity

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; 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	Behavioral: patients choose one creative activity and one physical activity; taking part in 2 activities (a creative one and a physical one)
Active Comparator: control arm; 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	Behavioral: patients choose one creative activity and one physical activity; taking part in 2 activities (a creative one and a physical one)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DERS questionnaire	differences between initial and final answers (after 6 months of intervention) scale composed of 36 items in 6 dimensions	6 months after baseline interview

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in quality of life: comparison between baseline assessment and assessment 2	With following scale of quality of life: SeiQoL	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	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	6 months after baseline interview

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2016
• Primary Completion (Actual): December 4, 2018
• Study Completion (Actual): December 4, 2018

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: September 20, 2016
• First Posted (Estimate): September 22, 2016

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 18, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Quality of Life; chronic ill patients; Emotion management skill
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: RC16_0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO