Impact of Depression Severity on Sexual Dysfunction (IODOEDPE)

# Detailed Study Procedure and Assessment Description

All participants included in this study will undergo a comprehensive psychiatric, psychosocial, medical, and sexual health assessment using a structured clinical interview conducted by trained psychiatry residents under the supervision of senior psychiatric staff at Sohag University Hospitals and Sohag Psychiatric Hospital. The assessment process will begin after explaining the purpose, objectives, confidentiality measures, and voluntary nature of participation to each participant, followed by obtaining informed written consent. Each participant will then be assigned an anonymous identification code to maintain privacy and confidentiality throughout all stages of data collection, analysis, and reporting. The interview will be conducted in a private and comfortable clinical setting to ensure accurate disclosure of sensitive sexual and psychological information and to minimize embarrassment, social desirability bias, or fear of stigma. Sociodemographic information will first be collected including age, residence, educational level, occupation, socioeconomic status, religion, duration of marriage, number of children, marital stability, and living arrangements. Additional marital and relationship-related data will also be obtained including quality of marital communication, emotional intimacy, presence of ongoing marital conflicts, spouse awareness of depressive symptoms, and the impact of sexual dysfunction on marital satisfaction and emotional bonding. Information regarding occupational stress, financial stressors, caregiving burdens, and family-related psychosocial difficulties will also be documented because of their potential influence on both depressive symptoms and sexual functioning.

A detailed psychiatric history will then be obtained from every participant. This assessment will include age at onset of depressive symptoms, duration of illness, pattern and course of depressive episodes, precipitating psychosocial stressors, previous psychiatric admissions, history of suicidal ideation or suicide attempts, family history of psychiatric disorders, and previous psychiatric treatments including antidepressant medications, psychotherapy, electroconvulsive therapy, or combined treatment approaches. Special emphasis will be placed on antidepressant medication history, particularly selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, and atypical antidepressants because of their possible association with sexual dysfunction. Drug dosage, duration of treatment, adherence, and temporal relationship between medication initiation and onset of sexual symptoms will be carefully explored. The severity of depressive symptoms will be assessed using the Hamilton Depression Rating Scale (HAM-D), Arabic version, which is a validated clinician-administered scale widely used to quantify depressive symptom severity. The HAM-D assessment will be performed by trained clinicians to ensure standardization and reliability of scoring. The scale evaluates multiple domains including depressed mood, guilt feelings, suicidal thoughts, insomnia, psychomotor retardation, agitation, anxiety symptoms, somatic symptoms, and impairment in work and daily activities. Based on total HAM-D scores, patients will be categorized into mild, moderate, severe, or very severe depression groups for further statistical analysis and comparison.

A detailed sexual history will subsequently be obtained in a respectful, confidential, and nonjudgmental manner. Participants will be asked about age at onset of sexual activity, frequency of sexual intercourse, level of sexual desire, quality of erections, ejaculation timing, sexual satisfaction, performance anxiety, and changes in sexual activity following the onset of depressive symptoms. Assessment of erectile dysfunction will include onset, duration, severity, progression, and whether symptoms are generalized or situational. Questions regarding morning erections and nocturnal erections will be included to help differentiate psychogenic from possible organic components of erectile dysfunction. Assessment of premature ejaculation will include estimated intravaginal ejaculatory latency time, degree of voluntary control over ejaculation, associated distress, frustration, interpersonal difficulties, and avoidance of sexual intimacy. Participants will also be asked about previous medical consultations for sexual dysfunction, prior pharmacological or behavioral treatments, and perceived effects of sexual dysfunction on self-esteem, masculinity, confidence, and marital relationship quality.

To objectively evaluate erectile dysfunction, the International Index of Erectile Function-5 (IIEF-5), Arabic validated version, will be administered to all participants. The IIEF-5 is a self-reported questionnaire designed to assess erectile confidence, erection firmness, maintenance ability, intercourse satisfaction, and overall erectile function during the previous six months. According to established cut-off scores, participants will be classified into no erectile dysfunction, mild, mild-to-moderate, moderate, or severe erectile dysfunction categories. Similarly, premature ejaculation will be assessed using the Premature Ejaculation Diagnostic Tool (PEDT), Arabic validated version. The PEDT is a standardized self-administered questionnaire that evaluates ejaculatory control, frequency of rapid ejaculation, distress associated with ejaculation timing, interpersonal difficulties, and overall satisfaction with sexual performance. Based on PEDT scoring, participants will be classified as having no premature ejaculation, probable premature ejaculation, or definite premature ejaculation. The use of validated Arabic versions of both assessment tools aims to improve reliability, cultural appropriateness, and participant comprehension.

Comprehensive medical and neurological history taking will also be performed to identify possible confounding factors associated with sexual dysfunction. Particular attention will be directed toward chronic medical illnesses known to impair sexual functioning including diabetes mellitus, hypertension, ischemic heart disease, chronic kidney disease, chronic liver disease, obesity, metabolic syndrome, endocrine disorders, thyroid dysfunction, benign prostatic hyperplasia, and neurological diseases such as stroke, epilepsy, multiple sclerosis, spinal cord disorders, or peripheral neuropathy. History of smoking, alcohol intake, substance abuse, caffeine intake, physical activity level, sleep quality, and dietary habits will also be documented because of their possible relationship with depressive symptoms and sexual health. Current and previous medications other than antidepressants will be reviewed carefully to exclude medications known to contribute to erectile dysfunction or premature ejaculation such as antihypertensive agents, antipsychotics, antiepileptic drugs, hormonal therapies, and recreational substances. Participants with primary sexual dysfunction predating depressive illness or with severe uncontrolled medical conditions significantly affecting sexual performance will be excluded from the study according to the exclusion criteria.

A focused physical and mental state examination will be carried out for all participants. Mental state examination will include assessment of appearance, behavior, speech, mood, affect, thought process, thought content, cognition, insight, and judgment. Assessment for psychotic symptoms, anxiety manifestations, obsessive symptoms, and substance misuse will also be conducted to identify psychiatric comorbidities that may influence sexual functioning or depressive severity. When clinically indicated, laboratory investigations may be requested including fasting blood glucose, HbA1c, liver function tests, kidney function tests, thyroid function tests, serum testosterone levels, prolactin levels, and lipid profile to exclude endocrine or metabolic contributors to sexual dysfunction. These investigations will not be mandatory for all participants but may be performed in selected cases according to clinical judgment.

All collected data will be entered into a coded electronic database and analyzed using the Statistical Package for Social Sciences (SPSS). Quantitative variables will be presented as means and standard deviations, while qualitative variables will be presented as frequencies and percentages. Comparative statistical analyses will be performed to determine the prevalence of erectile dysfunction and premature ejaculation among depressed patients and to evaluate the relationship between severity of depression and severity of sexual dysfunction. Correlation analyses will be used to assess the strength and direction of associations between HAM-D scores, IIEF-5 scores, and PEDT scores. Multivariate analyses may also be performed to control for confounding variables such as age, smoking status, chronic medical diseases, duration of marriage, and antidepressant use. Statistical significance will be considered at a p-value less than 0.05.

Throughout the study, all ethical principles related to biomedical research involving human participants will be strictly followed. Participants will have the full right to refuse participation or withdraw from the study at any stage without affecting their access to medical care. Confidentiality and anonymity will be maintained by storing data securely and restricting access only to the research team. Because the study addresses sensitive sexual and psychiatric topics, participants experiencing severe depressive symptoms, suicidal thoughts, severe marital distress, or significant untreated sexual dysfunction will be referred for appropriate psychiatric or sexual health management whenever needed. The findings of this study are expected to provide valuable information regarding the prevalence and severity of erectile dysfunction and premature ejaculation among depressed male patients in Sohag Governorate and may contribute to improving early detection, comprehensive psychiatric assessment, and integrated management strategies addressing both depression and sexual health in psychiatric practice.