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| Name | Class |
|---|---|
| CeRSM | UNKNOWN |
| COMUE | UNKNOWN |
| Poissy-Saint Germain Hospital | OTHER |
| Hôpital Raymond Poincaré |
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The purpose of this study is to evaluate the effectiveness of an 8-week intervention based on implementation intention (motivation) in patients with multiple sclerosis on objectively measured physical activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivation | Experimental | Using implementation intention techniques such as action planning. Every week, participants state when, where, and what kind of prescribed exercises they will do. |
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| Mindfulness | Active Comparator | 10 minutes of audio recordings daily. Recordings contain: awareness of the breath, acceptation of thoughts and emotions, awareness of postures, awareness during stretching, awareness of a single movement (moving legs up while standing). |
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| Treatment as usual | No Intervention | Physical activity prescribe 120 minutes per week. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivation | Behavioral | 8 weeks of either action planning or mindfulness in addition to a treatment as usual which is a physical activity program of 120 minutes per week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical activity | Accelerometer on a daily basis for 7 days | From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in self-reported anxiety and depression (HADS) | Hospital Anxiety and Depression Scale (2 subscales): anxiety (7 items) and depression (7 items) rated on a Likert-type scale ranging from 0 to 3. Total score for each subscale is the sum of each subscale's items. Higher scores indicate higher risks of anxiety and depression. | From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giovanni De Marco, Pr | Contact | 0033140975755 | demarco.giovanni@gmail.com | |
| Jean F Fournier, PhD | Contact | 0033140975639 | jean.fournier@u-paris10.fr |
| Name | Affiliation | Role |
|---|---|---|
| Emilie Dematte, MSc | Paris Nanterre University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Raymond-Poincaré | Recruiting | Garches | 92380 | France |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000092024 | Information Motivation Behavioral Skills Model |
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D008960 | Models, Psychological |
| D008962 | Models, Theoretical |
| D008919 | Investigative Techniques |
| D015928 | Cognitive Behavioral Therapy |
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| OTHER |
| Paris West University Nanterre La Défense | OTHER |
| Cite Sep | OTHER |
3 groups: motivation, mindfulness, and treatment as usual
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| Change in self-reported mindfulness skills (FFMQ) | Five-Facets Mindfulness Questionnaire (5 subscales): observing, describing, non-judging, non-reacting, acting with awareness. Each subscale is composed of 3 items rated on a Likert-type scale ranging from 1 to 5. Total score for each subscale is the sum of each subscale's items. Total mindfulness score is the sum of all subscales' scores. Higher scores indicate higher mindfulness skills. | From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up. |
| Change in self-reported motivational regulation toward exercise (BREQ) | Behavioral Regulation in Exercise Questionnaire (6 subscales): amotivation, external regulation, introjected regulation, integrated regulation, identified regulation, intrinsic regulation. Each subscale is composed of 3 items rated on a Likert-type scale ranging from 1 to 7. Total score for each subscale is the mean of each subscale's items. Higher scores indicate higher motivational regulation. | From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up. |
| Change in self-reported beliefs toward physical activity (TPB). | Theory of Planned Behavior constructs (4 concepts): attitudes (5 items), subjective norm (4 items), perceived behavioral control (2 items), intentions (3 items). All items are rated on a Likert-type scale ranging from 1 to 7. Total score for each subscale is the mean of each subscale's items. Higher scores indicate higher beliefs toward physical activity/ | From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up. |
| CHU Poissy Saint germain | Recruiting | Poissy | 78300 | France |
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| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |