Erectile DysfunctionNCT06996925
Depression, Illness Perception, and Erectile Dysfunction Outcomes
An observational study of Erectile Dysfunction and Depression, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction, Depression, Perception and Beliefs
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Mar 2025to 30 Sep 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Male patients aged 18 years or older
- Diagnosed with erectile dysfunction by a physician
- Able and willing to provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Haseki Education and Research Hospital
Istanbul
About this study
Official title: Erectile Dysfunction and the Mind: Evaluating the Influence of Depression and Illness Beliefs on Treatment Progression
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:
Read more
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.
Read the 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.
- Conditions
- Erectile Dysfunction, Depression, Perception and Beliefs
- Keywords
- erectile dysfunction, Depression, self perception
- Medical subject headings
- Erectile Dysfunction, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Erectile Dysfunction | This study includes adult male participants aged 18 and older who have been clinically diagnosed with erectile dysfunction (ED). All participants will have the condition of interest (ED), and there is no control group without the condition. The study group is homogeneous in that it consists solely of patients with ED, allowing for the evaluation of intra-individual changes over time in illness perception, depressive symptoms, and erectile functio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between illness perception and depressive symptoms
Change in depressive symptom scores (Patient Health Questionnaire-9, PHQ-9; range 0-27; higher scores indicate worse depressive symptoms) in relation to illness perception scores (Brief Illness Perception Questionnaire, B-IPQ; range 0-80; higher scores indicate more negative illness perceptions) at baseline and 1-month follow-up.
Measured: Baseline and 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start31 Mar 2025
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazım Furkan Günay, Haseki Training and Research Hospital
- Investigators
- Furkan Gunay, Medical doctor, Principal investigator, Haseki Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996925
- Sponsor's protocol ID
- 19.03.2025/23-2025
- Status last verified
- Aug 2025
- First submitted
- 21 May 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be made available to qualified researchers upon reasonable request. Requests will be evaluated by the principal investigator to ensure that the proposed use is scientifically and ethically appropriate. Data will be shared under a formal data use agreement that protects participant confidentiality and complies with ethical standards.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erectile Dysfunction and the Mind: Evaluating the Influence of Depression and Illness Beliefs on Treatment Progression
- ClinicalTrials.gov ID
- NCT06996925
- Acronym / sponsor ID
- 19.03.2025/23-2025
- Conditions
- Erectile Dysfunction, Depression, Perception and Beliefs
- Keywords
- erectile dysfunction, Depression, self perception
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erectile Dysfunction | – | –This study includes adult male participants aged 18 and older who have been clinically diagnosed with erectile dysfunction (ED). All participants will have the condition of interest (ED), and there is no control group without the condition. The study group is homogeneous in that it consists solely of patients with ED, allowing for the evaluation of intra-individual changes over time in illness perception, depressive symptoms, and erectile functio |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Male patients aged 18 years or older
- Diagnosed with erectile dysfunction by a physician
- Able and willing to provide written informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between illness perception and depressive symptoms
Time frame: Baseline and 1-month follow-up
Change in depressive symptom scores (Patient Health Questionnaire-9, PHQ-9; range 0-27; higher scores indicate worse depressive symptoms) in relation to illness perception scores (Brief Illness Perception Questionnaire, B-IPQ; range 0-80; higher scores indicate more negative illness perceptions) at baseline and 1-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be made available to qualified researchers upon reasonable request. Requests will be evaluated by the principal investigator to ensure that the proposed use is scientifically and ethically appropriate. Data will be shared under a formal data use agreement that protects participant confidentiality and complies with ethical standards.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Furkan Gunay, Medical doctor principal investigator
Haseki Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction and Depression, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between illness perception and depressive symptoms (time frame: Baseline and 1-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.