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| Name | Class |
|---|---|
| Direction Générale de l'Offre de Soins | OTHER_GOV |
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The effectiveness of psychomotor therapy in improving clinical outcomes or quality of life for individuals with depression is unclear.
The investigators will assess how the participants' quality of life and psychomotor profile change over time.
The study aims to compare the quality of life at 3 months between patients who received 3 months of personalised psychomotor therapy in addition to standard treatment and those who received standard treatment alone.
The study lasted for 6 months, and the investigators expects a total of 128 people to participate in this research across several hospital establishments. This study evaluates the effectiveness of two types of treatment, divided into two randomly selected groups.
To participate, individuals must have a medical diagnosis of major depressive disorder (MDD) and be between the ages of 20 and 60.
They must have depressive symptoms with an HDRS score greater than 16 and provide informed consent. They must be treated or hospitalised at the Centre Hospitalier Esquirol or the Centre Hospitalier Henri Laborit (France).
After providing consent, they will undergo an initial clinical interview that evaluates anxiety, self-esteem, pleasure, and quality of life. The therapist assessed the participant's muscle tone, gross motor skills, praxis, manual dexterity, rhythm, processing of sensory information, and body image.
Following the assessment, the participant was randomly assigned to either the experimental or control group.
The experimental group received the usual treatment for depression and underwent psychomotor therapy once a week for 12 weeks.
The control group received the standard treatment for depression and underwent weekly telephone interviews.
An assessment is scheduled at 1 month to evaluate the participant's health status, including any changes to treatment and assessment of anxiety and depressive symptoms.
Another interim check-up is scheduled at 3 months to assess the patient's health status. The interview will also assess any changes to treatment, anxiety and depressive symptoms, quality of life, and psychomotor function.
A final visit will be scheduled at 6 months for an assessment of the participant's health. The interview will also assess any changes to treatment, anxiety and depressive symptoms, quality of life, and psychomotor function.
Hypothesis is that personalised weekly psychomotor therapy for 3 months (period of remission of depression) has a positive influence on the quality of life over time of people with MDD by improving their clinical (anxiety/anhedonia/psychomotor impairment) and psychomotor symptoms.
In this study, the investigators propose to compare the quality of life of two groups of participants: a group receiving one psychomotor therapy session per week in addition to the usual treatments for depression, and a group receiving the usual treatments for depression. The investigators will evaluate changes in quality of life and psychomotor profile over time (at 3 and 6 months).
Based on the results of our pilot study, the psychomotor examination will include an assessment of muscle tone, gross motor skills, praxis, manual dexterity, rhythm using the NP-MOT battery, sensory processing and body image.
Main objective To compare the quality of life at 3 months (M3) between MDD patients receiving 3 months of personalised psychomotor therapy in addition to standard treatment (GP) and those receiving standard treatment alone (GC).
Secondary objectives
Primary outcome measure Difference at M3 between the GP and GC groups in the quality of life score assessed using the SF-36 (Short-Form 36 Health Survey) scale.
Secondary outcome measures
Difference between D0 and M3, D0 and M6, M3 and M6 in quality of life scores based on the SF-36.
Change in Duke Health Profile scores over the 12 weeks of follow-up (S1 to S12).
Number and nature of assessment items that differ at inclusion and 3 months between GP and GC using the Neuropsychomotor Function Assessment Battery (NP-MOT), Body Image Questionnaire (BIQ), Multidimensional Assessment of Interoceptive Awareness Version 2 (MAIAI-2), Adolescent/Adult Sensory Profile (AASP) tools
Depression intensity score on the Hamilton Depression Rating Scale (HDRS), anxiety intensity score on the Hamilton Anxiety Rating Scale (HARS), psychomotor slowing down score on the CORE scale, anhedonia score on the SHAPS scale, and body image score on the QIC and MAIA-2 scales, sensory profile scores on the AASP scale, frequency of tonic-emotional manifestations, sub-scores of the NP-MOT battery, at M3.
Clinical improvement score: 50% reduction in HDRS score, scores AASP, score QIC, score MAIA-2 and items sub-scores NP-MOT
Total number of sessions and score on the French version of the Therapeutic Alliance Session Rating Scale at M3
The inclusion criteria for participants in this study are as follows: being between the ages of 20 and 60, having a diagnosis of major depressive disorder according to DSM-5 criteria, having a HDRS score greater than 16 indicating major symptoms, and being hospitalized or receiving care at one of the participating centres.
Additionally, participants must be affiliated with or benefiting from a social security scheme.
The participant and investigator must sign a written consent form that is both free and informed. This must be completed no later than the day of inclusion and before any required research examinations.
Non-inclusion criteria for this study are: psychiatric co-morbidity (excluding tobacco addiction, eating disorders, bipolar disorder, obsessive-compulsive disorder, schizophrenia and related disorders), sensory disability or known neurological pathology, history of neurological damage to the brain (especially strokes, tumours, trauma resulting in loss of consciousness lasting more than 10 minutes), and limited functional ability (difficulty moving about, performing manual tasks or moving about).
Participants may be excluded from the study if they are unable to understand the questionnaires or related information, unable to travel to the inclusion centre via personal vehicle or public transport, pregnant or breastfeeding (as declared), subject to compulsory hospitalisation or under guardianship or trusteeship, or lack social protection.
The research is conducted as follows:
Quality of life scale (SF36) Clinical assessments: Hamilton Depression Rating Scale (HDRS); Hamilton Anxiety Rating Scale (HARS); psychomotor slowing down scale (CORE), Rosenberg Self-Esteem Scale (EES-10), Anhedonia Scale (SHAPS) Psychomotor assessment: sensory profile (AASP), body image (QIC, MAIA-2), tone (NP-MOT); general motor skills (NP-MOT), rhythm (NP-MOT); praxis (NP-MOT); manual dexterity (PPT) Randomisation: allocation of patients by drawing lots to the GP (personalised psychomotor therapy in addition to standard treatment) or GC (standard treatment) groups.
GP: Personalised psychomotor therapy: 1 psychomotor therapy session of 45 minutes per week for 12 weeks + Duke Health Scale.
The sessions will be based on static and dynamic body exercises involving muscle relaxation, breathing, sensations and moving the body. For each session the Session Rating Scale will be use.
GC: Usual care for 3 months with a weekly telephone interview + Duke's Health Scale.
At V2, the psychomotor assessment will be carried out by a psychomotor therapist who has not provided psychomotor therapy to the participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalised psychomotor therapy group | Experimental | 1 psychomotor therapy session of 45 minutes per week for 12 weeks + Duke Health Scale. |
|
| Usual treatment group | Active Comparator | Standard treatment for depression administered by a doctor + a weekly telephone interview for 12 weeks to administer the Duke Health Scale. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalised psychomotor therapy | Behavioral | The content of the sessions will be personalised and determined solely by a qualified psychomotor therapist in charge of the patient, based on each participant's individual psychomotor profile, as determined from the initial assessment. The 12 sessions will take place with the same PT in a dedicated room at the centre where the patient is being treated. The sessions will consist of a range of playful static and dynamic body exercises, including exercises for emotional and tonic regulation, tonic-postural adaptation, and perceptual-motor adaptation. Not all participants in the GP group will have the same progression, nature or frequency of exercises over the 12 sessions. The study only allows for individual treatment. Other therapeutic approaches such as balneotherapy sessions, animal mediation, adapted physical activity programmes or targeted relaxation programmes are not permitted. During each session, the participant will be required to complete the Duke health profile. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in quality of life assessed using the Short-Form 36 Health Survey | Difference between GP and GC groups in quality of life score | at 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in time of quality of life using the Short-Form 36 Health Survey | Difference between D0 and M3, D0 and M6, M3 and M6 in quality of life scores | first day to 6th month |
| Evolution of quality of life using the Duke health profile |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aude PAQUET, Dr | Contact | +33555431127 | aude.paquet@ch-esquirol-limoges.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Esquirol | Recruiting | Limoges | 87000 | France |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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Experimental Group: Personalised psychomotor therapy: 1 psychomotor therapy session of 45 minutes per week for 12 weeks + Duke Health Scale.
The sessions will be based on static and dynamic body exercises involving muscle relaxation, breathing, sensations and moving the body.
Control Group: Usual care for 12 weeks with a weekly telephone interview + Duke's Health Scale.
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| Usual treatment | Other | Participants in the GC group will continue to receive their usual depression treatment without any changes to their prescribed therapies. Their participation in the study will involve weekly monitoring of their quality of life using the Duke scale. A nurse or psychomotor therapist will conduct this monitoring during a weekly fifteen-minute telephone interview. The follow-up will begin one week after the inclusion visit and will last for 12 weeks. Telephone appointments will be scheduled jointly with the participant based on their availability. |
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|
Evolution of Duke health profile scores from week 1 to week 12 in both GP and GC groups
| first day to 6th month |
| Difference in psychomotor profile | Number and nature of assessment items that differ at 1 and 3 months between GP and GC using NP-MOT, QIC, MAIA-2, AASP tools | 3th and 6 th month |
| Description of depression intensity using the Hamilton Depression Rating Scale | clinical improvement concerning depression low score to Hamilton Depression Rating Scale indicate a low depressive intensity | at 3 month |
| Description of anxiety intensity using the Hamilton Anxiety Rating Scale | clinical improvement concerning anxiety low score to Hamilton Anxiety Rating Scale indicate a low anxiety intensity | at 3 month |
| Description of psychomotor slowing using the CORE scale | clinical improvement concerning psychomotor slowing low score to CORE Scale indicate a low psychomotor slowing | at 3 month |
| Description of anhedonia using the Snaith-Hamilton Pleasure Scale | clinical improvement concerning anhedonia low score to Snaith-Hamilton Pleasure Scale indicate a low anhedonia intensity | at 3 month |
| Description of body image using the Multidimensional Assessment of Interoceptive Awareness | clinical improvement concerning body image low score to Multidimensional Assessment of Interoceptive Awareness indicate a low interoceptive awarness | at 3 month |
| Description of sensory profile using the Adolescent Adult Sensory Profile | clinical improvement concerning sensory profile The AASP is composed by four subscores
| at 3 month |
| Frequency of tonic-emotional manifestations | observed reactions: awkward gestures, reassurance gestures, fixed smile, facial rictus, rigid body posture, contorting, stiffening, slightly theatrical posture, emotional uncontrol, neurovegetative manifestations: presence or absence | at 3 month |
| Frequency of psychomotor impairment using the NP-MOT battery | at 3 month |
| Frequency of sessions | Therapeutic alliance is mesured by number of sessions completed by GP participants out of 12 planned sessions. Session Rating Scale scores for the 12 sessions completed by GP participants. | at 3 month |