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IRCT20261012071397N1 IRCT 2026-10-16 Shahed University Exploring the Lived Experiences of Women with Husbands Suffering from Premature Ejaculation: Improvement, Feasibility, and Efficacy of an Individual Cognitive-Behavioral Treatment Package into a Couple-Oriented Package Based on the Findings of a Qualitative Study Exploring the Lived Experiences of Women with Husbands Suffering from Premature Ejaculation: Improvement, Feasibility, and Efficacy of an Individual Cognitive-Behavioral Treatment Package into a Couple-Oriented Package Based on the Findings of a Qualitative Study 2027-02-20 anticipated 8 Pending https://irct.ir/trial/94009 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Other design features: Unique Design Features of the Study: 1. Multi-Phase Design: This study consists of four distinct phases: (a) a qualitative phenomenological study exploring the lived experiences of women with husbands suffering from premature ejaculation; (b) development and improvement of an individual CBT package into a couple-oriented package based on qualitative findings; (c) feasibility assessment of the developed package based on experts', therapist's, and couples' opinions; (d) efficacy evaluation of the final package using a single-case experimental design. 2. Single-Case Experimental Design (SCED): The fourth phase employs a single-case design with multiple baselines. In this design, each couple serves as their own control, and data are collected during baseline, intervention, and follow-up phases. Classical randomization is not used; instead, phase assignment is based on baseline scheduling. 3. Couple-Oriented Nature of the Intervention: Unlike conventional individual- and symptom-focused treatments for premature ejaculation, this study designs a couple-oriented intervention, actively involving wives in treatment and addressing women's sexual needs and expectations. This approach is based on Phase 1 qualitative findings and women's lived experiences. 4. Mixed-Methods Approach: The present study employs a mixed-methods approach, in which the qualitative findings of the first phase inform the development of the treatment package in the second phase, which is then evaluated quantitatively in the third and fourth phases (feasibility and single-case). 5. Absence of Full Blinding: Due to the nature of the psychological intervention (couple-oriented CBT), full blinding of participants and therapists is not feasible. 6.Presence of a Male Research Collaborator: Given cultural considerations and the necessity of observing religious boundaries in sexual health interventions, male-specific sessions and joint couple sessions are conducted with the presence of a male therapist (Dr. Seyed Kazem Foroutan, Urologist and Head of the Family Health Clinic at Shahed University. 7.Emphasis on Theoretical Saturation in the Qualitative Study: The sample size in the first study is determined based on theoretical saturation (estimated 12–20 participants), and purposive sampling is employed. 8. Limited Sample Size in the Efficacy Study: The fourth study is conducted with 4 couples (plus 1 pilot couple), which is consistent with the nature of the single-case design and the goal of in-depth examination of the change process. N/A Premature ejaculation. **Intervention name:** Couple-oriented cognitive-behavioral therapy based on qualitative findings for premature ejaculation. **Intervention type:** Psychological – Cognitive/Behavioral (CBT). **Therapeutic method:** This intervention is based on a cognitive-behavioral treatment package initially developed in an individual format and then improved into a couple-oriented package using qualitative research findings (women's lived experiences) and active participation of couples. The main approach is a combination of cognitive techniques (correcting dysfunctional sexual thoughts and beliefs), behavioral techniques (exposure exercises, stop-start, communication), and couple-oriented techniques (increasing intimacy, communication skills, attention to women's sexual needs). **Number and duration of sessions:** Total sessions: 10. Duration per session: 60 to 90 minutes. Course duration: 10 weeks (one session per week). **Session content and structure:** Includes cognitive-behavioral education on premature ejaculation, ejaculation control techniques (stop-start, squeeze), anxiety management, and correcting dysfunctional sexual beliefs. Introductory education on sexual anatomy and physiology of men and women, communication and sexual dialogue skills, foreplay and intimacy exercises, attention to women's sexual needs and expectations, and couple-based homework. **Setting:** Family Health Clinic, Shahed University. **Equipment:** Private counseling room, printed questionnaires and worksheets, and educational materials. **Homework and worksheets:** Couple-based homework and in-session/out-of-session worksheets.. Yes - There is a plan to make this available What will be shared: Primary and Secondary Outcome Data Qualitative Data (Interviews) Protocol and Treatment Package Analytical Data and Results When: Access start date: 6 months after publication of the main results in a reputable scientific journal. Time frame: Unlimited. To whom: Academic and Scientific Institution Researchers Clinical Specialists and Therapists Ethics Committees and Scientific Reviewers Conditions: Request Conditions: Official request form + introduction letter + practice license + ethics approval + confidentiality agreement + DUA. Permitted analyses: Descriptive, inferential, statistical, qualitative. Not permitted analyses: Commercial, re-identification, destructive. Permitted use of documentation: Scientific, educational, clinical with citation. Not permitted use: Reproduction, sale, ownership claims, commercial use. Governing mechanisms: PI supervision, reporting, citation, no third-party transfer, specified validity period. Qualitative data: Key quotes only, without identifying information. Where to obtain: Applicants may request access to data or documentation through the following channels, in order of priority: 1. Principal Investigator (First Priority): Name: Zahra Khaksari Role: Principal Investigator Email: zahra.khaksari@shahed.ac.ir Mobile:00989046466233 Postal Address: Tehran, Palestine Street, Italia Street, Next to Shahid Mostafa Khomeini Hospital, Family Health Clinic, Shahed University 2. Supervisor (Second Priority): Name: Dr. Seyed Kazem Foroutan Role: Supervisor, Urologist Email: foroutan@shahed.ac.ir Postal Address: Tehran, Beginning of Tehran-Qom Freeway, Opposite the Holy Shrine of Imam Khomeini, Shahed University, Family Health Clinic How to obtain: Request Process: Submit form + introduction letter (1 week) PI review (1-2 weeks) Ethics approval (2-4 weeks) Sign confidentiality agreement + DUA (1 week) Data preparation and delivery (1-2 weeks) Post-use reporting Comments:
public Zahra Khaksari
No. 9, Italia Street, Palestine Street, Keshavarz Boulevard, Vali-e-Asr Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1416643491 +98 21 8898 5918 zahra.khaksari@shahed.ac.ir Shahed University scientific Seyed Kazem foroutan
No. 9, Italia Street, Palestine Street, Keshavarz Boulevard, Vali-e-Asr Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1416643491 +98 21 8898 5918 foroutan@shahed.ac.ir Shahed University Iran (Islamic Republic of) Couples with a husband diagnosed with premature ejaculation Confirmed diagnosis of the husband's premature ejaculation based on clinical interview and the PEDT questionnaire Absence of major psychiatric disorders (based on SCL-27) and personality disorders (based on PID-5-BF) in either spouse Absence of major marital conflicts No use of psychiatric medications affecting premature ejaculation within the past three months Willingness to participate and ability to communicate verbally At least two years of marital life Age 25 years and older for both spouses 25 years 45 years Both Presence of other sexual dysfunctions (e.g., erectile dysfunction) requiring independent treatment F52.4 Premature ejaculation Treatment - Other **Intervention name:** Couple-oriented cognitive-behavioral therapy based on qualitative findings for premature ejaculation. **Intervention type:** Psychological – Cognitive/Behavioral (CBT). **Therapeutic method:** This intervention is based on a cognitive-behavioral treatment package initially developed in an individual format and then improved into a couple-oriented package using qualitative research findings (women's lived experiences) and active participation of couples. The main approach is a combination of cognitive techniques (correcting dysfunctional sexual thoughts and beliefs), behavioral techniques (exposure exercises, stop-start, communication), and couple-oriented techniques (increasing intimacy, communication skills, attention to women's sexual needs). **Number and duration of sessions:** Total sessions: 10. Duration per session: 60 to 90 minutes. Course duration: 10 weeks (one session per week). **Session content and structure:** Includes cognitive-behavioral education on premature ejaculation, ejaculation control techniques (stop-start, squeeze), anxiety management, and correcting dysfunctional sexual beliefs. Introductory education on sexual anatomy and physiology of men and women, communication and sexual dialogue skills, foreplay and intimacy exercises, attention to women's sexual needs and expectations, and couple-based homework. **Setting:** Family Health Clinic, Shahed University. **Equipment:** Private counseling room, printed questionnaires and worksheets, and educational materials. **Homework and worksheets:** Couple-based homework and in-session/out-of-session worksheets. Severity of premature ejaculation symptoms in men. Timepoint: Severity of premature ejaculation symptoms in men is measured at the following time points: 1. Baseline: At least three measurements before the start of the intervention, at one-week intervals, to establish the baseline trend and symptom stability. 2. During Intervention: After the start of the intervention, assessments are conducted at the end of sessions 3, 6, and 9 (i.e., weeks 3, 6, and 9, respectively). 3. Post-Intervention (Post-test): Immediately after the completion of the 10-week sessions. Follow-up: 1.5 months after the end of the intervention. Method of measurement: Tool: Premature Ejaculation Diagnostic Tool (PEDT) and Intravaginal Ejaculatory Latency Time (IELT) measurement.Method: The PEDT questionnaire is completed by the affected man. The IELT is measured based on the couples' self-report. Men's Sexual Quality of Life. Timepoint: Men's sexual quality of life is measured at the following time points:1. Baseline: At least three measurements before the start of the intervention, at one-week intervals, to establish the baseline trend and symptom stability. 2. During Intervention: After the start of the intervention, assessments are conducted at the end of sessions 3, 6, and 9 (i.e., weeks 3, 6, and 9, respectively). 3. Post-Intervention (Post-test): Immediately after the completion of the 10-week sessions. Follow-up: 1.5 months after the end of the intervention. Method of measurement: Sexual Quality of Life Questionnaire for Men (SQOL-M) by Abraham et al. (2008). Couples' sexual satisfaction. Timepoint: Couples' sexual satisfaction is measured at the following time points:1. Baseline: At least three measurements before the start of the intervention, at one-week intervals, to establish the baseline trend and symptom stability. 2. During Intervention: After the start of the intervention, assessments are conducted at the end of sessions 3, 6, and 9 (i.e., weeks 3, 6, and 9, respectively). 3. Post-Intervention (Post-test): Immediately after the completion of the 10-week sessions. Follow-up: 1.5 months after the end of the intervention. Method of measurement: Golombok-Rust Sexual Satisfaction Questionnaire. Couples' marital adjustment. Timepoint: Couples' marital adjustment is measured at the following time points:1. Baseline: At least three measurements before the start of the intervention, at one-week intervals, to establish the baseline trend and symptom stability. 2. During Intervention: After the start of the intervention, assessments are conducted at the end of sessions 3, 6, and 9 (i.e., weeks 3, 6, and 9, respectively). 3. Post-Intervention (Post-test): Immediately after the completion of the 10-week sessions. Follow-up: 1.5 months after the end of the intervention. Method of measurement: Revised Dyadic Adjustment Scale (RDAS) by Busby et al. Female sexual function. Timepoint: Female sexual function is measured at the following time points:1. Baseline: At least three measurements before the start of the intervention, at one-week intervals, to establish the baseline trend and symptom stability. 2. During Intervention: After the start of the intervention, assessments are conducted at the end of sessions 3, 6, and 9 (i.e., weeks 3, 6, and 9, respectively).3. Post-Intervention (Post-test): Immediately after the completion of the 10-week sessions. Follow-up: 1.5 months after the end of the intervention. Method of measurement: Female Sexual Function Index (FSFI) self-report questionnaire by Rosen et al. Sexual Quality of Life-Female. Timepoint: Sexual Quality of Life-Female is measured at the following time points:1. Baseline: At least three measurements before the start of the intervention, at one-week intervals, to establish the baseline trend and symptom stability. 2. During Intervention: After the start of the intervention, assessments are conducted at the end of sessions 3, 6, and 9 (i.e., weeks 3, 6, and 9, respectively). 3. Post-Intervention (Post-test): Immediately after the completion of the 10-week sessions. Follow-up: 1.5 months after the end of the intervention. Method of measurement: Sexual Quality of Life-Female questionnaire (SQOL-F) by Symonds et al (2005). Shahed University Approved 2026-09-01 Ethics committee of Shahd University of Medical Sciences Khalij-e Fars Highway (Beginning of Tehran-Qom Freeway), Opposite the Holy Shrine of Imam Khomeini, Shahed University Tehran Tehran Iran (Islamic Republic of)