Relationships Among Inflammation, Physical and Mental Health in Subjects With Chronic Inflammatory Physical Diseases.

NCT05125458 | Completed DMC

• 1 other identifier: 417
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of common mental disorders is high in patients with chronic inflammatory physical diseases(e.g., autoimmune or infectious diseases). The traditional explanatory causation model in which physical symptoms and related disability drive mental health problems is now called into question, and evidence has accumulated supporting more complex interactions whereby psychiatric disorders can both result from and contribute to the progression of physical diseases. In the present project, the investigators will focus on comorbidity of depression and anxiety symptoms or syndromes with chronic inflammatory skin diseases (psoriasis, hidradenitis suppurativa and atopic dermatitis) or chronic infectious diseases (chronic HBV and HIV infection). The study is aimed to clarify the mechanisms underlying the high frequency of those comorbidities. It will overcome the main limitations of previous investigations and use innovative statistical tools to model complex interrelationships and causal links among the assessed variables. The identification of key variables driving the causal chain of determinants of poor global health and quality of life may impact treatment outcome and models of care.

Conditions

Chronic Infectious Disease; Chronic Skin Disease; Mental Disorders; Psoriasis; Hidradenitis Suppurativa; Atopic Dermatitis; Hiv; HBV

Keywords

Quality of life; Network analysis

Outcome Measures

Primary Outcomes (29)

• Socio-demographic Data

  A clinical form will be filled in to collect socio-demographic and clinical data such as age, education level, marital status, employment, age of onset and treatments.

  At recruitment (T0)

• Assessment of psoriasis

  The Psoriasis Area and Severity Index (PASI) will be used to assess the severity of psoriasis. According to this tool, psoriatic plaques are graded based on three criteria: redness, thickness, and scaliness. Severity is rated for each index on a 0-4 scale (0 for no involvement up to 4 for severe involvement). The body is divided into four regions comprising head, upper extremities, trunk, and lower extremities. In each of these areas, the fraction of total surface area affected is graded on a 0-6 scale (0 for no involvement, 6 for greater than 90% involvement). Various body regions are weighted to reflect their respective proportion of body surface area (BSA). The composite PASI score can then be calculated by multiplying the sum of the individual-severity scores for each region by the weighted area-of-involvement score for that respective region, and then summing the four resulting values. The highest potential PASI score is 72; the lowest is 0.

  At recruitment (T0)

• Assessment of hidradenitis suppurativa

  Severity of hidradenitis suppurativa will be evaluated by using the Hurley staging system. It classifies patients into three stages: I, single or multiple abscesses without sinus tracts and cicatrization; II, single or multiple, recurrent, widely separated abscesses with tract formation and cicatrization; III, diffuse involvement, or multiple interconnected tracts.

  At recruitment (T0)

• Assessment of atopic dermatitis

  Severity of atopic dermatitis will be assessed by means of the Eczema Area and Severity Index (EASI). It evaluates four body regions: head/neck, trunk, upper and lower extremities. Each of them is separately assessed for erythema (redness), induration/papulation/edema (thickness), excoriation (scratching), and lichenification. The average degree of severity of each sign in each regions is scored from 0 to 3. Symptoms (e.g. pruritus) and secondary signs (e.g. xerosis, scaling) are excluded from the area assessments. For each region, the clinician evaluates the intensity for each of the four signs and calculates the severity score. For each region, the severity score is multiplied by the area score and by a multiplier, that is different for each body site. The final EASI score is the sum of total scores of the four regions. The minimum EASI score is 0, the maximum is 72.

  At recruitment (T0)

• Lifetime psychiatric comorbidity

  The Mini International Neuropsychiatric Interview-Plus (MINI-PLUS) will be administered to all subjects to assess lifetime comorbidity with Axis I psychiatric disorders.

  At recruitment (T0)

• The Hospital Anxiety and Depression

  The Hospital Anxiety and Depression Scale (HADS), a tool designed to assess anxiety and depression in physically ill patients, will be used. It is a 14-item self-assessment scale including two subscales, respectively composed by seven items measuring anxiety and seven measuring depression. Responses are scored from 0 to 3, with subscale total scores ranging from 0 to 21 points (score ranges for severity: 0-7 = normal; 8-10 = mild; 11-14 = moderate; 15-21 = severe).

  At recruitment (T0)

• Anxiety

  The Hamilton Anxiety Rating Scale (HAM-A), a clinician-administered rating scale of 14 items, will be used to measure both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score ranging from 0 to 56 (score ranges for severity of anxiety: \<17 = mild; 18-24 = mild to moderate; \>25 = moderate to severe).

  At recruitment (T0)

• Depression

  The Hamilton Depression Rating Scale (HAM-D-17) will be used to assess severity of depressive symptoms. It is a clinician-administered rating scale including 17 items pertaining to symptoms of depression experienced over the past week. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe, while the remaining nine items are scored from 0 to 2. Sum of item scores ranges from 0 to 50 (score ranges for severity of depression: 0-7 = absent; 8-13 = mild; 14-18 = moderate; 19-22 = severe; ≥ 23 = very severe).

  At recruitment (T0)

• Global Physical Assessments: Patient Global Assessment

  The Patient Global Assessment Visual-Analogic Scale, a self-administered scale, will be used to evaluate how physical condition is considered subjectively from the patient. The scale consist of a simple, single item (with no subscale) that measures the overall impact of the disease on the global health of the patient at a specific point in time. It is scored using a visual analogue scale (VAS), anchored on an unnumbered 10-cm horizontal line. Higher scores represent a higher level of disease activity and a worse global health. The proposed definition of "low global assessment" is ≤2.0 (scale 0-10).

  At recruitment (T0)

• Global Physical Assessments: Physician Assessment

  The global severity of the physical diseases listed in the inclusion criteria will be assessed using the Physician Global Assessment Visual-Analogic Scale, a scale administered by the clinician. This scale consist of a simple, single item (with no subscale) that measures the overall impact of the disease on the global health of the patient at a specific point in time as evaluated by the physician. It is scored using a visual analogue scale (VAS), anchored on an unnumbered 10-cm horizontal line. Higher scores represent a higher level of disease activity and a worse global health. The proposed definition of "low global assessment" is ≤2.0 (scale 0-10).

  At recruitment (T0)

• Global Physical Assessments: severity of physical diseases

  The assessment of the severity of physical diseases will be performed using the Modified Cumulative Illness Rating Scale (CIRS). It includes elements related to 13 clinical areas: heart; hypertension; circulation; respiratory system; head and neck; upper digestive tract; lower digestive tract; liver; kidney; genitourinary system; musculoskeletal and integumentary systems; nervous system and endocrine-metabolic system. For each system, in case two or more pathologies are present, only the one with the greatest clinical impact or associated with the greatest disability will be scored; each score ranges from 0 (the system is not affected by any pathology,) to 4 (very serious pathology and/or need for urgent treatment and/or organ failure and/or severe functional disability). The scale will generate four scores: total score, number of affected systems, severity index (total score/number of affected systems) and number of affected systems with scores of 4-5 (serious or extremely serious).

  At recruitment (T0)

• Assessment of disability

  The World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS-II) will be used to assess disability. It is a 36-item self-administered questionnaire on health-related difficulties experienced in the previous month. The instrument evaluates six domains: communication, mobility, self-care, getting along with people, life activities (divided into household and work) and participation in society. Answers are rated on a 5-point scale, from "no difficulties" to "cannot do the activity". Total and subscale scores are calculated, with higher scores reflecting greater disability.

  At recruitment (T0)

• Assessment of quality of life

  The 12-Item Short Form Health Survey (SF-12), a brief, self-administered questionnaire, will assess health-related quality of life, including eight domains: physical functioning, role limitations due to physical health, pain, general health, vitality (energy/fatigue), social functioning, role limitations due to mental health. Items are rated on a dichotomous or a Likert scale. The score of each dimension is computed and transformed into a scale from zero (worst health) to 100 (best health). The 8 scales can be summarized into a mental component summary (MCS) score and a physical component summary (PCS) score, that are expressed as T-scores.

  At recruitment (T0)

• Neurocognitive domains

  Neurocognition will be evaluated by means of the Cambridge Neuropsychological Test Automated Battery (CANTAB), a computer-based cognitive assessment system. It consists of a battery of neuropsychological tests that can be administered via an iPad.

  At recruitment (T0)

• Coping skills

  Coping skills will be assessed using the Coping Orientation to Problems Experienced inventory - Brief (Brief-COPE) including 28 items and 14 subscales: positive reframing, self-distraction, expression, use of instrumental support, active coping, denial, religion, humor, behavioral disengagement, use of emotional support, substance use, acceptance, planning, self-blame. Sum of item scores ranges from 28 to 112.

  At recruitment (T0)

• Stigma

  The Stigma Scale for Chronic Illness-8 (SSCI-8) will be used to assess internalized stigma (patient feelings and thoughts concerning his/her condition) and externalized stigma (instances of actual discrimination related to the disease) related to chronic diseases.

  At recruitment (T0)

• Plasma levels of IL-1α

  Plasma concentration of IL-1α will be measured by ELISA kits. The assay will be run in duplicate for each patient, along with a standard curve from which plasma concentrations of the analytes will be derived.

  At recruitment (T0)

• Plasma levels of IL-6

  Plasma concentration of IL-6 will be measured by ELISA kits. The assay will be run in duplicate for each patient, along with a standard curve from which plasma concentrations of the analytes will be derived.

  At recruitment (T0)

• Plasma levels of TNF-α

  Plasma concentration of TNF-α will be measured by ELISA kits. The assay will be run in duplicate for each patient, along with a standard curve from which plasma concentrations of the analytes will be derived.

  At recruitment (T0)

• Plasma levels of ICAM-1

  Plasma concentration of ICAM-1 will be measured by ELISA kits. The assay will be run in duplicate for each patient, along with a standard curve from which plasma concentrations of the analytes will be derived.

  At recruitment (T0)

• Plasma levels of VCAM-1

  Plasma concentration of VCAM-1 will be measured by ELISA kits. The assay will be run in duplicate for each patient, along with a standard curve from which plasma concentrations of the analytes will be derived.

  At recruitment (T0)

• Assessment of D-dimers levels

  D-dimers will be assessed in the clinical and molecular laboratory services of the University Hospital.

  At recruitment (T0)

• Assessment of Fibrogen levels

  Fibrinogen levels will be assessed in the clinical and molecular laboratory services of the University Hospital.

  At recruitment (T0)

• Assessment of white blood cells levels

  White blood cells (WBC) levels will be assessed in the clinical and molecular laboratory services of the University Hospital.

  At recruitment (T0)

• Assessment of PLT levels

  PLT levels will be assessed in the clinical and molecular laboratory services of the University Hospital.

  At recruitment (T0)

• Assessment CD4 and CD8

  Levels of CD4 and CD8 will be assessed by calculating the CD4/CD8 ratio through plasma analysis in the clinical and molecular laboratory services of the University Hospital.

  At recruitment (T0)

• Assessment of hs-CRP levels

  Levels of a high-sensitivity C-reactive protein (hs-CRP) will be assessed through plasma analysis in the clinical and molecular laboratory services of the University Hospital.

  At recruitment (T0)

• Markers of subclinical inflammatory damage: assessment of subclinical endothelial damage

  To assess markers of subclinical endothelial damage, an Ultrasonography of the epi-aortic vessels will be performed by using a power colour-Doppler instrument with 7.5 MHz probes. Characteristics of the intima will be evaluated. A minimum of three measurements will be collected on the common carotid artery (1 cm before the carotid bifurcation and at carotid bifurcation) and on the internal carotid (1 cm after the carotid bifurcation and 2 cm after the carotid bifurcation). An intima-media thickness (IMT) of \>1 mm will be considered to be pathological. Atherosclerotic plaques, if present, will be described. All images will be photographed and properly archived.

  At recruitment (T0)

• Markers of subclinical inflammatory damage: assessment of bone quality

  Markers of bone quality will be evaluated by means of Bone quantitative ultrasound (QUS), a technique based on high frequency sound waves generated by the device to determine bone health status. T-scores and Z-scores will be calculated.

  At recruitment (T0)

Study Arms (2)

Subjects with dermatological diseases

500 Subjects attending the Dermatology outpatient clinic of the Vanvitelli University hospital with a diagnosis of psoriasis or hidradenitis suppurativa or atopic dermatitis of any grade of severity.

Subjects with HIV or HBV

500 Subjects attending the Infectious diseases outpatient clinic of the Vanvitelli University hospital and with HIV or HBV infection.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinically stable outpatients among those attending the Dermatology or Infectious disease outpatient clinics of the University of Campania Hospital.

You may qualify if:

• diagnosis of psoriasis, hidradenitis suppurativa, or atopic dermatitis, any grade of severity;
• stability of the cutaneous disease;
• ongoing treatment.
• documented HIV or HBV infection;
• treatment with antiviral therapy;
• viral suppression (HIV-RNA or HBV-DNA) for at least 6 months.
• age ≥ 18 years
• willingness to provide informed consent.

You may not qualify if:

• \- a history of intellectual disability, bipolar disorder, psychosis or schizophrenia, or current high suicide risk.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Department of Psychiatry - University of Campania "Luigi Vanvitelli"

Napoli, 80138, Italy

Location

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MeSH Terms

Conditions

Persistent Infection; Mental Disorders; Psoriasis; Hidradenitis Suppurativa; Dermatitis, Atopic; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Hidradenitis; Sweat Gland Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes

Study Officials

• Silvana Galderisi

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: November 18, 2021
• Study Start: April 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

IT (1)