Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05686668
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-01-17
First Post:
2022-12-15
Brief Title:
Evolution of the Sensory Profile in Depression
Sponsor:
Centre Hospitalier Esquirol
Organization:
Centre Hospitalier Esquirol
Study Overview
Official Title:
Evolution of the Sensory Profile in Depression
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEPSENS
Brief Summary:
The perception of the environment through the study of sensory awareness is important to understand the adaptive or symptomatological behaviors eg 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
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
Detailed Description:
Main objective To compare the sensory profiles ie the distribution of sensory processing patterns at each quadrant of the AASP of subjects with major depressive disorder at the beginning of hospitalization V1 and 3 months later V2
Secondary objectives
Objective 1 To describe at V1 and V2 the sensory profiles according to the clinical characteristics anxiety depression psychomotor slowing self-esteem anhedonia a difference in the relationship between the clinical scales and the quadrants AASP at V2 and V1 could be observed
Objective 2 To look for a difference in sensory profile at V2 according to clinical improvement
Objective 3 To compare at V1 the distribution of processing patterns of sensory profiles for each quadrant of the AASP according to coping styles CISS
Objective 4 To compare the distribution of processing patterns of sensory profiles sensory profiles for each quadrant of the AASP according to socio-demographic characteristics gender age group professional category type of type of housing environment family situation
Objective 5 To look for a difference in the distribution of the processing patterns sensory profiles between the first inclusion visit V1 and 3 months V2 according to the type of drug treatment molecules and classes and non psychotherapy relaxation rTMS ECT Inclusion criteria
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
Non inclusion criteria
Psychiatric comorbidity personality disorder addiction other than tobacco eating disorder bipolar disorder obsessive-compulsive disorder schizophrenia and related disorders
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
Outcome Measures Primary endpoints
- AASP at V1 and V2 Secondary endpoints
1 AASP HARS HAM-D CORE EES-10 SHAPS at V1 and V2
2 AASP HAM-D at V2
3 AASP ISSC
4 AASP scores and socio-demographic characteristics age sex ratio living environment family status housing
5 AASP scores and treatments at V1 and V2
Secondary objectives
Objective 1 To describe at V1 and V2 the sensory profiles according to the clinical characteristics anxiety depression psychomotor slowing self-esteem anhedonia a difference in the relationship between the clinical scales and the quadrants AASP at V2 and V1 could be observed
Objective 2 To look for a difference in sensory profile at V2 according to clinical improvement
Objective 3 To compare at V1 the distribution of processing patterns of sensory profiles for each quadrant of the AASP according to coping styles CISS
Objective 4 To compare the distribution of processing patterns of sensory profiles sensory profiles for each quadrant of the AASP according to socio-demographic characteristics gender age group professional category type of type of housing environment family situation
Objective 5 To look for a difference in the distribution of the processing patterns sensory profiles between the first inclusion visit V1 and 3 months V2 according to the type of drug treatment molecules and classes and non psychotherapy relaxation rTMS ECT Inclusion criteria
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
Non inclusion criteria
Psychiatric comorbidity personality disorder addiction other than tobacco eating disorder bipolar disorder obsessive-compulsive disorder schizophrenia and related disorders
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
Outcome Measures Primary endpoints
- AASP at V1 and V2 Secondary endpoints
1 AASP HARS HAM-D CORE EES-10 SHAPS at V1 and V2
2 AASP HAM-D at V2
3 AASP ISSC
4 AASP scores and socio-demographic characteristics age sex ratio living environment family status housing
5 AASP scores and treatments at V1 and V2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None