Clinical trial NCT06996925: Depression, Illness Perception, and Erectile Dysfunction Outcomes
Official title: Erectile Dysfunction and the Mind: Evaluating the Influence of Depression and Illness Beliefs on Treatment Progression
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Erectile Dysfunction
Depression
Perception and Beliefs
Keywords: erectile dysfunction
Depression
self perception
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from the outpatient urology clinics of Haseki Training and Research Hospital and collaborating centers. All participants will be adult male patients who present with complaints consistent with erectile dysfunction and meet the diagnostic criteria during clinical evaluation.

Brief summary: The goal of this observational study is to evaluate the impact of illness perception and depressive symptoms on treatment outcomes in adult male patients diagnosed with erectile dysfunction (ED).

The main questions it aims to answer are:

Is there a relationship between negative illness perception and increased severity of depressive symptoms in ED patients? Does the change in illness perception over time correlate with changes in erectile function and depression levels?

Participants will:

Complete the IIEF-5 (International Index of Erectile Function - 5) to assess erectile dysfunction severity, Complete the B-IPQ (Brief Illness Perception Questionnaire) to evaluate their cognitive and emotional representations of ED, Complete the PHQ-9 (Patient Health Questionnaire - 9) to measure depressive symptoms, Repeat these assessments at baseline and at a 1-month follow-up. This study does not involve any intervention or comparison group. It is designed to track psychological and clinical changes over time and explore modifiable psychological predictors in the management of ED.

Detailed description: This prospective, observational study aims to investigate the relationship between illness perception and depressive symptoms in patients diagnosed with erectile dysfunction (ED), and how these factors influence treatment response over time. Erectile dysfunction is a multifactorial condition that significantly affects quality of life and can be shaped by psychological and cognitive factors, including patients' perceptions of their disease.

A total of 120 adult male participants (aged \>18 years) diagnosed with ED will be enrolled from multiple urology centers. Patients will complete three validated instruments at baseline and again at a 1-month follow-up:

IIEF-5 (International Index of Erectile Function - 5): to assess severity of erectile dysfunction.

B-IPQ (Brief Illness Perception Questionnaire): to evaluate cognitive and emotional representations of their condition.

PHQ-9 (Patient Health Questionnaire - 9): to screen for and quantify depressive symptoms.

The primary outcome of the study is to determine the association between baseline illness perception (as measured by B-IPQ) and the severity of depressive symptoms (PHQ-9 scores). Secondary outcomes include changes in erectile function (IIEF-5) and depressive symptoms at 1 month, and whether these changes correlate with changes in illness perception. Additionally, specific components of illness perception such as personal control, treatment control, concern, and emotional response will be analyzed in relation to treatment adherence and psychological well-being.

Data Quality and Management Procedures:

A structured case report form (CRF) will be used for consistent data entry. A data dictionary will define each variable and ensure uniform interpretation of collected data.

Data checks will be performed to validate internal consistency (e.g., checking for missing or out-of-range values).

Source data verification will involve comparison of collected responses with patients' medical records when applicable.

Standard Operating Procedures (SOPs) will be followed for data collection, participant follow-up, and data management.

Sample Size and Statistical Plan:

A power analysis indicated a required sample size of 120 participants to detect a moderate correlation (r = 0.3) between illness perception and depressive symptoms with 80% power and a 5% significance level.

Statistical analysis will include:

Descriptive statistics for demographic and clinical variables. Pearson or Spearman correlation analysis between B-IPQ, PHQ-9, and IIEF-5 scores.

Paired t-tests or Wilcoxon signed-rank tests to assess within-group changes over time.

Multivariate regression analysis to control for potential confounders such as age, comorbidities, and duration of ED.

Missing Data Plan:

Cases with missing responses will be addressed using multiple imputation methods where appropriate. Sensitivity analyses will be conducted to assess the impact of missing data on study outcomes.

This study will provide insight into how modifiable psychological factors such as illness beliefs influence both psychological distress and sexual health, potentially informing future patient education and intervention strategies.

Eligibility criteria: Inclusion Criteria:

* Male patients aged 18 years or older
* Diagnosed with erectile dysfunction by a physician
* Able and willing to provide written informed consent

Exclusion Criteria:

* History of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder)
* Ongoing or prior hormonal therapy or active cancer treatment
* Neurological conditions that could impact erectile function

Primary outcomes:
measure: Association between illness perception and depressive symptoms
timeFrame: Baseline and 1-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haseki Education and Research Hospital
Study officials:
affiliation: Haseki Education and Research Hospital
name: Furkan Gunay, Medical doctor
role: PRINCIPAL_INVESTIGATOR
References: