Impact of Psychomotor Therapy on the Quality of Life in Depression
ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorCentre Hospitalier Esquirol
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of depressive episode according to DSM-5 criteria.
HDRS > 16
Hospitalized or followed-up in one of the participating centers.
Affiliated or beneficiary of a social security scheme.
Disqualifiers
Psychiatric comorbidity (non-tobacco addiction, eating disorders, bipolar disorder, obsessive-compulsive disorder, schizophrenia and related disorders)
Sensory impairment or proven neurological pathology
History of neurological brain damage (including stroke, tumor, trauma resulting in loss of consciousness lasting more than 10 minutes)
Limited functional ability (difficulty in moving about, performing manual tasks or moving about)
Trial design
Design model
Parallel
Treatments tested in this trial
Personalised psychomotor therapy
BehavioralThe 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.
Usual treatment
Other interventionParticipants 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.
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Personalised psychomotor therapy groupExperimental treatment 1 intervention
Group B: Usual treatment groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Difference in quality of life assessed using the Short-Form 36 Health Survey
Difference between GP and GC groups in quality of life score
Time frame
at 3 monthSecondary outcomes
1
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
Time frame
first day to 6th month2
Evolution of quality of life using the Duke health profile
Evolution of Duke health profile scores from week 1 to week 12 in both GP and GC groups
Time frame
first day to 6th month3
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
Time frame
3th and 6 th month4
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
Time frame
at 3 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Hospitalier Esquirol
Lead sponsor
Direction Générale de l'Offre de Soins
Collaborator
Source ClinicalTrials.gov