NCT05686668

Brief Summary

The perception of the environment through the study of sensory awareness is important to understand the adaptive or symptomatological behaviors (e.g., withdrawal, increased activity level, stimulation seeking, etc.). Sensory processing disorders, such as hypersensitivities or hyposensitivities, have been described in people with depression using the Adolescent Adult Sensory Profile scale. In a recent study, similar results consistent with extreme sensory profiles (hypersensitivity, hyposensitivity, sensation avoidance) in adults with a major depressive disorder were observed. The evolution over time of the sensory profile in people with a depressive disorder is not known. It is currently unknown whether these extreme sensory processing profiles are stable over time or whether they may evolve with the depressive symptomatology to normalize with clinical improvement. This knowledge could have an important impact both on the symptomatological expression of the disorder, its recognition, and also on the management of the patient. The investigators aim to study the evolution over time of the sensory profile of depressed subjects hospitalized using the ASSP. The behavioral responses of individuals with sensory processing disorder may be related to the coping strategies of these individuals with their living environment. In a second step, the investigators will study the second step the sensory profile of subjects with depression according to their coping strategies, their living environment and their clinical characteristics (anxiety (anxiety, psychomotor slowing, self-esteem, anhedonia).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

Same day

First QC Date

December 15, 2022

Last Update Submit

February 17, 2025

Conditions

Keywords

Major Depressive DisorderAdolescent Adult Sensory ProfileSensory ProfilesCoping

Outcome Measures

Primary Outcomes (1)

  • Change in Adolescent Adult Sensory Profile score

    measure a change in Adolescent Adult Sensory Profile score between he beginning of hospitalization and 3 months

    day 0 and 3 months

Secondary Outcomes (7)

  • Hamilton Anxiety Rating Scale score

    day 0 and 3 months

  • number of participants with psychomotor retardation

    day 0 and 3 months

  • Snaith-Hamilton pleasure scale score

    day 0 and 3 months

  • Coping Inventory for Stressful Situations score

    day 0

  • number of participants living in country

    day 0

  • +2 more secondary outcomes

Study Arms (1)

AASP

Other: assessment by scales

Interventions

Assessment from many scales: AASP, HARS, HDRS, CORE, EES, CISS, SHAPS at V1 Assessment from many scales: AASP, HARS, HDRS, CORE, EES, SHAPS at V2

AASP

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospitalized poeple for a major depressive disorder

You may qualify if:

  • Male or female, 18 to 65 years of age
  • who have given informed consent
  • with a diagnosis of a major depressive disorder according to the DSM-5 criteria
  • in full hospitalization for less than 10 days in the care units of the Esquirol Hospital

You may not qualify if:

  • Psychiatric comorbidity (personality disorder, addiction other than tobacco, eating disorder, bipolar disorder, obsessive-compulsive disorder, schizophrenia and related disorders)
  • Proven sensory or neurological disability
  • Inability to understand the questionnaires and information related to the study
  • Hospitalization under constraint, pregnancy, subjects under guardianship or curatorship, lack of social protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH Esquirol

Limoges, 87000, France

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Psychomotor Therapist

Study Record Dates

First Submitted

December 15, 2022

First Posted

January 17, 2023

Study Start

January 10, 2022

Primary Completion

January 10, 2022

Study Completion

January 10, 2024

Last Updated

February 18, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations