Nctid:
NCT06234176
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003866", "term"=>"Depressive Disorder"}, {"id"=>"D000003863", "term"=>"Depression"}, {"id"=>"D000003865", "term"=>"Depressive Disorder, Major"}], "ancestors"=>[{"id"=>"D000019964", "term"=>"Mood Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}, {"id"=>"D000001526", "term"=>"Behavioral Symptoms"}], "browseLeaves"=>[{"id"=>"M7058", "name"=>"Depression", "asFound"=>"Depressive Disorder", "relevance"=>"HIGH"}, {"id"=>"M7061", "name"=>"Depressive Disorder", "asFound"=>"Depressive Disorder", "relevance"=>"HIGH"}, {"id"=>"M7060", "name"=>"Depressive Disorder, Major", "asFound"=>"Major Depressive Disorder", "relevance"=>"HIGH"}, {"id"=>"M21835", "name"=>"Mood Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M4818", "name"=>"Behavioral Symptoms", "relevance"=>"LOW"}, {"id"=>"T6034", "name"=>"Quality of Life", "asFound"=>"Quality of Life", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Experimental Group: Personalised psychomotor therapy: 1 psychomotor therapy session of 45 minutes per week for 12 weeks + Duke Health Scale.\n\nThe sessions will be based on static and dynamic body exercises involving muscle relaxation, breathing, sensations and moving the body.\n\nControl Group: Usual care for 12 weeks with a weekly telephone interview + Duke's Health Scale."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>128}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-04", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-08", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-29", "studyFirstSubmitDate"=>"2024-01-15", "studyFirstSubmitQcDate"=>"2024-01-29", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-08", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Difference in quality of life assessed using the Short-Form 36 Health Survey", "timeFrame"=>"at 3 month", "description"=>"Difference between GP and GC groups in quality of life score"}], "secondaryOutcomes"=>[{"measure"=>"Difference in time of quality of life using the Short-Form 36 Health Survey", "timeFrame"=>"first day to 6th month", "description"=>"Difference between D0 and M3, D0 and M6, M3 and M6 in quality of life scores"}, {"measure"=>"Evolution of quality of life using the Duke health profile", "timeFrame"=>"first day to 6th month", "description"=>"Evolution of Duke health profile scores from week 1 to week 12 in both GP and GC groups"}, {"measure"=>"Difference in psychomotor profile", "timeFrame"=>"3th and 6 th month", "description"=>"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"}, {"measure"=>"Description of depression intensity using the Hamilton Depression Rating Scale", "timeFrame"=>"at 3 month", "description"=>"clinical improvement concerning depression low score to Hamilton Depression Rating Scale indicate a low depressive intensity"}, {"measure"=>"Description of anxiety intensity using the Hamilton Anxiety Rating Scale", "timeFrame"=>"at 3 month", "description"=>"clinical improvement concerning anxiety low score to Hamilton Anxiety Rating Scale indicate a low anxiety intensity"}, {"measure"=>"Description of psychomotor slowing using the CORE scale", "timeFrame"=>"at 3 month", "description"=>"clinical improvement concerning psychomotor slowing low score to CORE Scale indicate a low psychomotor slowing"}, {"measure"=>"Description of anhedonia using the Snaith-Hamilton Pleasure Scale", "timeFrame"=>"at 3 month", "description"=>"clinical improvement concerning anhedonia low score to Snaith-Hamilton Pleasure Scale indicate a low anhedonia intensity"}, {"measure"=>"Description of body image using the Multidimensional Assessment of Interoceptive Awareness", "timeFrame"=>"at 3 month", "description"=>"clinical improvement concerning body image low score to Multidimensional Assessment of Interoceptive Awareness indicate a low interoceptive awarness"}, {"measure"=>"Description of sensory profile using the Adolescent Adult Sensory Profile", "timeFrame"=>"at 3 month", "description"=>"clinical improvement concerning sensory profile The AASP is composed by four subscores\n\n* norm for low registration subcore is between 24-35\n* norm for sensation seeking subcore is between 43-56\n* norm for lsensory sensitivity subcore is between 26-41\n* norm for sensation avoiding subcore is between 27-41"}, {"measure"=>"Frequency of tonic-emotional manifestations", "timeFrame"=>"at 3 month", "description"=>"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"}, {"measure"=>"Frequency of psychomotor impairment using the NP-MOT battery", "timeFrame"=>"at 3 month"}, {"measure"=>"Frequency of sessions", "timeFrame"=>"at 3 month", "description"=>"Therapeutic alliance is mesured by number of sessions completed by GP participants out of 12 planned sessions.\n\nSession Rating Scale scores for the 12 sessions completed by GP participants."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["psychomotor therapy", "quality of life", "major depressive disorder", "psychomotor profile", "sensory processing"], "conditions"=>["Major Depressive Disorder"]}, "descriptionModule"=>{"briefSummary"=>"The effectiveness of psychomotor therapy in improving clinical outcomes or quality of life for individuals with depression is unclear.\n\nThe investigators will assess how the participants' quality of life and psychomotor profile change over time.\n\nThe 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.\n\nThe 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.\n\nTo participate, individuals must have a medical diagnosis of major depressive disorder (MDD) and be between the ages of 20 and 60.\n\nThey 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).\n\nAfter 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.\n\nFollowing the assessment, the participant was randomly assigned to either the experimental or control group.\n\nThe experimental group received the usual treatment for depression and underwent psychomotor therapy once a week for 12 weeks.\n\nThe control group received the standard treatment for depression and underwent weekly telephone interviews.\n\nAn 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.\n\nAnother 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.\n\nA 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.", "detailedDescription"=>"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.\n\nIn 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).\n\nBased 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.\n\nMain 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).\n\nSecondary objectives\n\n1. 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.\n2. 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.\n3. 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.\n4. 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.\n5. Evaluate at M3, in the GP group, the number of sessions completed and the therapeutic alliance using a scale.\n\nPrimary 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.\n\nSecondary outcome measures\n\n1. Difference between D0 and M3, D0 and M6, M3 and M6 in quality of life scores based on the SF-36.\n\n Change in Duke Health Profile scores over the 12 weeks of follow-up (S1 to S12).\n2. 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\n3. 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.\n4. Clinical improvement score: 50% reduction in HDRS score, scores AASP, score QIC, score MAIA-2 and items sub-scores NP-MOT\n5. Total number of sessions and score on the French version of the Therapeutic Alliance Session Rating Scale at M3\n\nThe 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.\n\nAdditionally, participants must be affiliated with or benefiting from a social security scheme.\n\nThe 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.\n\nNon-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).\n\nParticipants 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.\n\nThe research is conducted as follows:\n\n* 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.\n* Reflection period: between 24 and 72 hours.\n* 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.\n\nQuality 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.\n\nGP: Personalised psychomotor therapy: 1 psychomotor therapy session of 45 minutes per week for 12 weeks + Duke Health Scale.\n\nThe 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.\n\nGC: Usual care for 3 months with a weekly telephone interview + Duke's Health Scale.\n\n* 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\n* 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\n* 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.\n\nAt V2, the psychomotor assessment will be carried out by a psychomotor therapist who has not provided psychomotor therapy to the participant."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"20 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Diagnosis of depressive episode according to DSM-5 criteria.\n* HDRS \\> 16\n* Hospitalized or followed-up in one of the participating centers.\n* Affiliated or beneficiary of a social security scheme.\n* Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research).\n\nExclusion Criteria:\n\n* Psychiatric comorbidity (non-tobacco addiction, eating disorders, bipolar disorder, obsessive-compulsive disorder, schizophrenia and related disorders)\n* Sensory impairment or proven neurological pathology\n* History of neurological brain damage (including stroke, tumor, trauma resulting in loss of consciousness lasting more than 10 minutes)\n* Limited functional ability (difficulty in moving about, performing manual tasks or moving about)\n* Inability to understand questionnaires and study information\n* Inability to travel to the inclusion center (personal vehicle, public transport)\n* Pregnant or breast-feeding women, on declaration\n* Forced hospitalization, subjects under guardianship or trusteeship, lack of social protection"}, "identificationModule"=>{"nctId"=>"NCT06234176", "acronym"=>"PsyMot-Dep", "briefTitle"=>"Impact of Psychomotor Therapy on the Quality of Life in Depression", "organization"=>{"class"=>"OTHER", "fullName"=>"Centre Hospitalier Esquirol"}, "officialTitle"=>"Influence of Psychomotor Therapy on Quality of Life in Patients With a Major Depressive Disorder: a Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"2023-A02678-37"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Personalised psychomotor therapy group", "description"=>"1 psychomotor therapy session of 45 minutes per week for 12 weeks + Duke Health Scale.", "interventionNames"=>["Behavioral: Personalised psychomotor therapy"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Usual treatment group", "description"=>"Standard treatment for depression administered by a doctor + a weekly telephone interview for 12 weeks to administer the Duke Health Scale.", "interventionNames"=>["Other: Usual treatment"]}], "interventions"=>[{"name"=>"Personalised psychomotor therapy", "type"=>"BEHAVIORAL", "otherNames"=>["GP"], "description"=>"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.\n\nThe 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.\n\nNot all participants in the GP group will have the same progression, nature or frequency of exercises over the 12 sessions.\n\nThe 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.\n\nDuring each session, the participant will be required to complete the Duke health profile.", "armGroupLabels"=>["Personalised psychomotor therapy group"]}, {"name"=>"Usual treatment", "type"=>"OTHER", "otherNames"=>["GC"], "description"=>"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.", "armGroupLabels"=>["Usual treatment group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"87000", "city"=>"Limoges", "country"=>"France", "facility"=>"CH Esquirol", "geoPoint"=>{"lat"=>45.83153, "lon"=>1.25781}}], "centralContacts"=>[{"name"=>"Aude PAQUET, Dr", "role"=>"CONTACT", "email"=>"aude.paquet@ch-esquirol-limoges.fr", "phone"=>"+33555431127"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Centre Hospitalier Esquirol", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Direction Générale de l'Offre de Soins", "class"=>"OTHER_GOV"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Psychomotor Therapist, Psychology PhD", "investigatorFullName"=>"Aude Paquet", "investigatorAffiliation"=>"Centre Hospitalier Esquirol"}}}}
