Impact of Psychomotor Therapy on the Quality of Life in Depression

NCT06234176 | Recruiting

• 1 other identifier: 2023-A02678-37
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

psychomotor therapy; quality of life; major depressive disorder; psychomotor profile; sensory processing

Outcome Measures

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

  at 3 month

Secondary Outcomes (12)

• Difference in time of quality of life using the Short-Form 36 Health Survey

  first day to 6th month

• Evolution of quality of life using the Duke health profile

  first day to 6th month

• Difference in psychomotor profile

  3th and 6 th month

• Description of depression intensity using the Hamilton Depression Rating Scale

  at 3 month

• Description of anxiety intensity using the Hamilton Anxiety Rating Scale

  at 3 month

Study Arms (2)

Personalised psychomotor therapy group

EXPERIMENTAL

1 psychomotor therapy session of 45 minutes per week for 12 weeks + Duke Health Scale.

Behavioral: Personalised psychomotor therapy

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.

Other: Usual treatment

Interventions

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.

Also known as: GP

Personalised psychomotor therapy group

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.

Also known as: GC

Usual treatment group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Pregnant or breast-feeding women, on declaration
• Forced hospitalization, subjects under guardianship or trusteeship, lack of social protection

Sponsors & Collaborators

• Centre Hospitalier Esquirol: lead
• Direction Générale de l'Offre de Soins: collaborator

Study Sites (1)

CH Esquirol

Limoges, 87000, France

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Aude PAQUET, Dr

CONTACT

+33555431127; aude.paquet@ch-esquirol-limoges.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychomotor Therapist, Psychology PhD

Model Details: 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.

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 31, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

FR (1)