Clinical trial NCT05686668: Evolution of the Sensory Profile in Depression
Official title: Evolution of the Sensory Profile in Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Adolescent Adult Sensory Profile
Sensory Profiles
Coping
Lead sponsor: Centre Hospitalier Esquirol
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized poeple for a major depressive disorder

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).

Detailed description: Main objective To compare the sensory profiles, i.e., 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

Eligibility criteria: 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Adolescent Adult Sensory Profile score
timeFrame: day 0 and 3 months
Secondary outcomes:
measure: Hamilton Anxiety Rating Scale score
timeFrame: day 0 and 3 months
measure: number of participants with psychomotor retardation
timeFrame: day 0 and 3 months
measure: Snaith-Hamilton pleasure scale score
timeFrame: day 0 and 3 months
measure: Coping Inventory for Stressful Situations score
timeFrame: day 0
measure: number of participants living in country
timeFrame: day 0
measure: number of participants living lonely
timeFrame: day 0
measure: Treatments
timeFrame: day 0 and 3 months
Other outcomes:
Locations:
city: Limoges
country: France
facility: CH Esquirol
Study officials:
References: