Influence of Psychomotor Therapy on Quality of Life in Patients With a Major Depressive Disorder: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Difference in quality of life assessed using the Short-Form 36 Health Survey
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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).
排除标准
- •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)
- •Inability to understand questionnaires and study information
- •Inability to travel to the inclusion center (personal vehicle, public transport)
- •Pregnant or breast-feeding women, on declaration
- •Forced hospitalization, subjects under guardianship or trusteeship, lack of social protection
研究组 & 干预措施
Personalised psychomotor therapy group
1 psychomotor therapy session of 45 minutes per week for 12 weeks + Duke Health Scale.
干预措施: Personalised psychomotor therapy (Behavioral)
Usual treatment group
Standard treatment for depression administered by a doctor + a weekly telephone interview for 12 weeks to administer the Duke Health Scale.
干预措施: Usual treatment (Other)
结局指标
主要结局
Difference in quality of life assessed using the Short-Form 36 Health Survey
时间窗: at 3 month
Difference between GP and GC groups in quality of life score
次要结局
- Difference in time of quality of life using the Short-Form 36 Health Survey(first day to 6th month)
- Description of anhedonia using the Snaith-Hamilton Pleasure Scale(at 3 month)
- Description of body image using the Multidimensional Assessment of Interoceptive Awareness(at 3 month)
- Frequency of tonic-emotional manifestations(at 3 month)
- Evolution of quality of life using the Duke health profile(first day to 6th month)
- Description of depression intensity using the Hamilton Depression Rating Scale(at 3 month)
- Difference in psychomotor profile(3th and 6 th month)
- Description of anxiety intensity using the Hamilton Anxiety Rating Scale(at 3 month)
- Description of sensory profile using the Adolescent Adult Sensory Profile(at 3 month)
- Description of psychomotor slowing using the CORE scale(at 3 month)
- Frequency of psychomotor impairment using the NP-MOT battery(at 3 month)
- Frequency of sessions(at 3 month)
研究者
Aude Paquet
Psychomotor Therapist, Psychology PhD
Centre Hospitalier Esquirol