Ignite Creation Date:
2025-12-18 @ 8:56 AM
Ignite Modification Date:
2025-12-18 @ 8:56 AM
Study NCT ID:
NCT06234176
Status:
None
Last Update Posted:
2025-02-19 00:00:00
First Post:
2024-01-15 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Psychomotor Therapy on the Quality of Life in Depression
Sponsor:
None
Organization:
Study Overview
Official Title:
Influence of Psychomotor Therapy on Quality of Life in Patients With a Major Depressive Disorder: a Randomized Controlled Trial
Status:
None
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PsyMot-Dep
Brief Summary:
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
1. To compare changes in quality of life over time between D0/M3, D0/M6 and M3/M6 in patients in the GP and GC groups; a difference between the groups will be sought.
2. Identify the psychomotor assessment items (tone, general motor skills, praxis, rhythm, body image, sensory profile) that differ at inclusion (D0) and 3 months (M3) between the GP and GC groups.
3. To identify clinical factors of depression (intensity of depression, anxiety, psychomotor slowing, anhedonia) associated with a difference in psychomotor profile at M3 between the GP and GC groups.
4. Identify items predictive of clinical improvement in depression based on psychomotor assessment items (tone, general motor skills, praxis, rhythm, body image, sensory profile) at 6 months (M6) in patients in the GP and GC groups.
5. Evaluate at M3, in the GP group, the number of sessions completed and the therapeutic alliance using a scale.
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
1. 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).
2. 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
3. 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.
4. Clinical improvement score: 50% reduction in HDRS score, scores AASP, score QIC, score MAIA-2 and items sub-scores NP-MOT
5. 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:
* Pre-selection by the coordinating investigator or co-investigator, validation of participation criteria by the referring doctor and information of participants by the referring doctor or coordinating investigator or staff associated with the research.
* Reflection period: between 24 and 72 hours.
* V0: Inclusion Collect of written consent, Socio-demographic data (age, sex, family situation, profession, place of residence, environment), psychiatric history, treatments received (medicinal and non-medicinal), etc.
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.
* V1: visit at 1 month ± 4 days for an interim assessment Treatments received and/or modified in the last 4 weeks Clinical assessments: HDRS; HARS; CORE, EES-10, SHAPS
* V2: visit at 3 months ± 7 days Treatments received and/or modified in the last 3 months Clinical assessments: HDRS; HARS; CORE, EES-10, SHAPS Number of psychomotricity sessions performed Quality of life scale (SF36) Blind psychomotor assessment: AASP, QIC, MAIA-2, NP-MOT
* V3: visit at 6 months ± 7 days Treatments received and/or modified in the last 3 months Clinical assessments: HDRS; HARS; CORE, EES-10, SHAPS Quality of life scale (SF36) Blind psychomotor assessment: AASP, QIC, MAIA-2, NP-MOT Participants in the GC group were offered 12 sessions of psychomotor therapy.
At V2, the psychomotor assessment will be carried out by a psychomotor therapist who has not provided psychomotor therapy to the participant.
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
1. To compare changes in quality of life over time between D0/M3, D0/M6 and M3/M6 in patients in the GP and GC groups; a difference between the groups will be sought.
2. Identify the psychomotor assessment items (tone, general motor skills, praxis, rhythm, body image, sensory profile) that differ at inclusion (D0) and 3 months (M3) between the GP and GC groups.
3. To identify clinical factors of depression (intensity of depression, anxiety, psychomotor slowing, anhedonia) associated with a difference in psychomotor profile at M3 between the GP and GC groups.
4. Identify items predictive of clinical improvement in depression based on psychomotor assessment items (tone, general motor skills, praxis, rhythm, body image, sensory profile) at 6 months (M6) in patients in the GP and GC groups.
5. Evaluate at M3, in the GP group, the number of sessions completed and the therapeutic alliance using a scale.
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
1. 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).
2. 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
3. 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.
4. Clinical improvement score: 50% reduction in HDRS score, scores AASP, score QIC, score MAIA-2 and items sub-scores NP-MOT
5. 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:
* Pre-selection by the coordinating investigator or co-investigator, validation of participation criteria by the referring doctor and information of participants by the referring doctor or coordinating investigator or staff associated with the research.
* Reflection period: between 24 and 72 hours.
* V0: Inclusion Collect of written consent, Socio-demographic data (age, sex, family situation, profession, place of residence, environment), psychiatric history, treatments received (medicinal and non-medicinal), etc.
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.
* V1: visit at 1 month ± 4 days for an interim assessment Treatments received and/or modified in the last 4 weeks Clinical assessments: HDRS; HARS; CORE, EES-10, SHAPS
* V2: visit at 3 months ± 7 days Treatments received and/or modified in the last 3 months Clinical assessments: HDRS; HARS; CORE, EES-10, SHAPS Number of psychomotricity sessions performed Quality of life scale (SF36) Blind psychomotor assessment: AASP, QIC, MAIA-2, NP-MOT
* V3: visit at 6 months ± 7 days Treatments received and/or modified in the last 3 months Clinical assessments: HDRS; HARS; CORE, EES-10, SHAPS Quality of life scale (SF36) Blind psychomotor assessment: AASP, QIC, MAIA-2, NP-MOT Participants in the GC group were offered 12 sessions of psychomotor therapy.
At V2, the psychomotor assessment will be carried out by a psychomotor therapist who has not provided psychomotor therapy to the participant.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: