Situational Erectile Dysfunction Clinical Trial
— PRIMEDOfficial title:
Providing Insight Into and Mindfulness for Situational Erectile Dysfunction
NCT number | NCT04341025 |
Other study ID # | H18-00665 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 14, 2020 |
Est. completion date | December 2024 |
Erectile dysfunction (ED) is among the most common sexual dysfunctions experienced by men, affecting at least one third of men across the lifespan. Although pharmacological treatments are available, adherence to these treatments is poor, suggesting the need for integration of psychological interventions. This study will determine if a 6-session mindfulness-based psychosexual therapy (MBPST) group will be effective and feasible for men with situational ED. This study is adapted from a previously published 4-session MBPST protocol which was found to be beneficial for men with situational ED. Outcomes are measured using self-report questionnaires on sexual functioning/enjoyment, relationship satisfaction, and treatment acceptability.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: This study is open to individuals who are: - Diagnosed with situational erectile dysfunction (ED) of at least 6 months duration, as assessed by a physician at the BC Centre for Sexual Medicine according to DSM-5 criteria - 19 years of age or older - Fluent enough in English to participate in group - Willing to abstain from using medications for ED (i.e., PDE5 inhibitors, intracavernosal injections, MUSE etc.) from the start of treatment until the 1-month follow-up (totaling 10 weeks) - Comfortable and interested in participating in a small group format with 6-10 others Exclusion Criteria: This study is not suitable for individuals who: - Do not experience an exacerbation of ED in the partnered context - Have a current unmanaged health condition (e.g., unmanaged diabetes mellitus) or unstable mental health condition (e.g., severe depression/anxiety, active suicidal ideation) that would interfere with self- or partnered-sexual activities or with group participation - Do no feel comfortable participating in a small group format with 6-10 others |
Country | Name | City | State |
---|---|---|---|
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Vancouver Coastal Health |
Canada,
Bossio JA, Basson R, Driscoll M, Correia S, Brotto LA. Mindfulness-Based Group Therapy for Men With Situational Erectile Dysfunction: A Mixed-Methods Feasibility Analysis and Pilot Study. J Sex Med. 2018 Oct;15(10):1478-1490. doi: 10.1016/j.jsxm.2018.08.0 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient Satisfaction towards therapy group and Self-reported Impact on Quality of Sexual Life as measured by Patient Global Impression of Change Scale - Revised | (adapted from Hurst & Bolton, 2004) This is a single self-report question on participants overall satisfaction from and impact from the treatment group | Change from baseline to immediately post treatment (6 weeks) | |
Other | Patient Satisfaction towards therapy group and Self-reported Impact on Quality of Sexual Life as measured by Patient Global Impression of Change Scale - Revised | (adapted from Hurst & Bolton, 2004). This is a single self-report question on participants overall satisfaction from and impact from the treatment group | Change from baseline to one month post-treatment (10 weeks) | |
Other | Patient Satisfaction towards therapy group and Self-reported Impact on Quality of Sexual Life as measured by Patient Global Impression of Change Scale - Revised | (adapted from Hurst & Bolton, 2004) This is a single self-report question on participants overall satisfaction from and impact from the treatment group | Change from baseline to four months post-treatment (22 weeks) | |
Other | PDE5 inhibitor Medication Use | As measured by self-report questions asking men about their use of PDE5 inhibitor medications to erectile functioning, and their perception of these medications usefulness | Change from baseline to immediately post treatment (6 weeks) | |
Other | PDE5 inhibitor Medication Use | As measured by self-report questions asking men about their use of PDE5 inhibitor medications to erectile functioning, and their perception of these medications usefulness | Change from baseline to one month post-treatment (10 weeks) | |
Other | PDE5 inhibitor Medication Use | As measured by self-report questions asking men about their use of PDE5 inhibitor medications to erectile functioning, and their perception of these medications usefulness | Change from baseline to four months post-treatment (22 weeks) | |
Other | Mindfulness and Sexual Activities Practice as measured by investigator-created questionnaire | Daily log of types of activities and minutes practiced | Change from baseline to immediately post treatment (6 weeks) | |
Other | Mindfulness and Sexual Activities Practice as measured by investigator-created questionnaire | Daily log of types of activities and minutes practiced | Change from baseline to one month post-treatment (10 weeks) | |
Other | Mindfulness and Sexual Activities Practice as measured by investigator-created questionnaire | Daily log of types of activities and minutes practiced | Change from baseline to four months post-treatment (22 weeks) | |
Primary | Self-reported Erectile Functioning as measured by International Index of Erectile Function - 5 | (IIEF-5; Rosen, Cappelleri, Smith, Lipsky, & Pena, 1999); 5 item questionnaire | Change from baseline to immediately post treatment (6 weeks) | |
Primary | Self-reported Erectile Functioning as measured by International Index of Erectile Function - 5 | (IIEF-5; Rosen, Cappelleri, Smith, Lipsky, & Pena, 1999); 5 item questionnaire | Change from baseline to one month post-treatment (10 weeks) | |
Primary | Self-reported Erectile Functioning as measured by International Index of Erectile Function - 5 | (IIEF-5; Rosen, Cappelleri, Smith, Lipsky, & Pena, 1999); 5 item questionnaire | Change from baseline to four months post-treatment (22 weeks) | |
Primary | Self-reported Sexual Distress as measured by Sexual Distress Scale-Revised | (Derogatis, Clayton, Lewis-D'Agostino, Wunderlich, & Fu, 2008). This scale was recently validated for measuring sexual distress in men (Santos-Iglesias, Mohamed, Danko, & Walker, 2018); 13 item rating scale | Change from baseline to immediately post treatment (6 weeks) | |
Primary | Self-reported Sexual Distress as measured by Sexual Distress Scale-Revised | (Derogatis, Clayton, Lewis-D'Agostino, Wunderlich, & Fu, 2008). This scale was recently validated for measuring sexual distress in men (Santos-Iglesias, Mohamed, Danko, & Walker, 2018); 13 item rating scale | Change from baseline to one month post-treatment (10 weeks) | |
Primary | Self-reported Sexual Distress as measured by Sexual Distress Scale-Revised | (Derogatis, Clayton, Lewis-D'Agostino, Wunderlich, & Fu, 2008). This scale was recently validated for measuring sexual distress in men (Santos-Iglesias, Mohamed, Danko, & Walker, 2018); 13 item rating scale | Change from baseline to four months post-treatment (22 weeks) | |
Primary | Self-reported Confidence in Sexual and Erectile Competence as measured by Sexual Self-Efficacy Scale - Erectile Functioning | (Fichten, Spector, Amsel, Creti, Brender, & Libman, 1998), which measures confidence in sexual and erectile competence; 25 item rating scale | Change from baseline to immediately post treatment (6 weeks) | |
Primary | Self-reported Confidence in Sexual and Erectile Competence as measured by Sexual Self-Efficacy Scale - Erectile Functioning | (Fichten, Spector, Amsel, Creti, Brender, & Libman, 1998), which measures confidence in sexual and erectile competence; 25 item rating scale | Change from baseline to one month post-treatment (10 weeks) | |
Primary | Self-reported Confidence in Sexual and Erectile Competence as measured by Sexual Self-Efficacy Scale - Erectile Functioning | (Fichten, Spector, Amsel, Creti, Brender, & Libman, 1998), which measures confidence in sexual and erectile competence; 25 item rating scale | Change from baseline to four months post-treatment (22 weeks) | |
Primary | Self-reported Sexual Satisfaction and Pleasure as measured by International Index of Erectile Function - Overall Satisfaction Subscale. | (Rosen, Riley, Wagner, Osterloh, Kirkpatrick, & Mishra, 1997), which measures sexual satisfaction. 2-item questionnaire | Change from baseline to immediately post treatment (6 weeks) | |
Primary | Self-reported Sexual Satisfaction and Pleasure as measured by International Index of Erectile Function - Overall Satisfaction Subscale | (Rosen, Riley, Wagner, Osterloh, Kirkpatrick, & Mishra, 1997), which measures sexual satisfaction. 2-item questionnaire | Change from baseline to one month post-treatment (10 weeks) | |
Primary | Self-reported Sexual Satisfaction and Pleasure as measured by International Index of Erectile Function - Overall Satisfaction Subscale | (Rosen, Riley, Wagner, Osterloh, Kirkpatrick, & Mishra, 1997), which measures sexual satisfaction. 2-item questionnaire | Change from baseline to four months post-treatment (22 weeks) | |
Primary | Self-reported Sexual Pleasure as measured by an investigator-created Questionnaire | 2-item self report questionnaire on a 5-point scale assessing physical and emotional sexual pleasure. | Change from baseline to immediately post treatment (6 weeks) | |
Primary | Self-reported Sexual Pleasure as measured by an investigator-created Questionnaire | 2-item self report questionnaire on a 5-point scale assessing physical and emotional sexual pleasure. | Change from baseline to one month post-treatment (10 weeks) | |
Primary | Self-reported Sexual Pleasure as measured by an investigator-created Questionnaire | 2-item self report questionnaire on a 5-point scale assessing physical and emotional sexual pleasure. | Change from baseline to four months post-treatment (22 weeks) | |
Secondary | Anxiety Symptoms as measured by Generalized Anxiety Disorder-7 | (Spitzer, Kroenke, Williams, & Lowe, 2006),7-item questionnaire | Change from baseline to immediately post treatment (6 weeks) | |
Secondary | Anxiety Symptoms as measured by Generalized Anxiety Disorder-7 | (Spitzer, Kroenke, Williams, & Lowe, 2006), 7-item questionnaire | Change from baseline to one month post-treatment (10 weeks) | |
Secondary | Anxiety Symptoms as measured by Generalized Anxiety Disorder-7 | (Spitzer, Kroenke, Williams, & Lowe, 2006), 7-item questionnaire | Change from baseline to four months post-treatment (22 weeks) | |
Secondary | Degree of Mindfulness as measured by the Five Facet Mindfulness Questionnaire-15 | (Baer, Carmody, Hunsinger, 2012; Gu, Strauss, Crane, Barnhofer, Karl, Cavanagh, & Kuyken, 2016),15-item questionnaire | Change from baseline to immediately post treatment (6 weeks) | |
Secondary | Degree of Mindfulness as measured by the Five Facet Mindfulness Questionnaire-15 | (Baer, Carmody, Hunsinger, 2012; Gu, Strauss, Crane, Barnhofer, Karl, Cavanagh, & Kuyken, 2016),15-item questionnaire | Change from baseline to one month post-treatment (10 weeks) | |
Secondary | Degree of Mindfulness as measured by the Five Facet Mindfulness Questionnaire-15 | (Baer, Carmody, Hunsinger, 2012; Gu, Strauss, Crane, Barnhofer, Karl, Cavanagh, & Kuyken, 2016),15-item questionnaire | Change from baseline to four months post-treatment (22 weeks) | |
Secondary | Non-attachment mindfulness skill as measured by Nonattachment Scale-7 | (Sahdra, Ciarrochi, Parker, Marshall, & Heaven, 2015) Non-attachment is a specific facet of mindfulness measured by this 7-item questionnaire | Change from baseline to immediately post treatment (6 weeks) | |
Secondary | Non-attachment mindfulness skill as measured by Nonattachment Scale-7 | (Sahdra, Ciarrochi, Parker, Marshall, & Heaven, 2015) Non-attachment is a specific facet of mindfulness measured by this 7-item questionnaire | Change from baseline to one month post-treatment (10 weeks) | |
Secondary | Non-attachment mindfulness skill as measured by Nonattachment Scale-7 | (Sahdra, Ciarrochi, Parker, Marshall, & Heaven, 2015) Non-attachment is a specific facet of mindfulness measured by this 7-item questionnaire | Change from baseline to four months post-treatment (22 weeks) | |
Secondary | Relationship satisfaction as measured by Relationship Assessment Scale | (Hendrick, 1988) 7-item questionnaire | Change from baseline to immediately post treatment (6 weeks) | |
Secondary | Relationship satisfaction as measured by Relationship Assessment Scale | (Hendrick, 1988) 7-item questionnaire | Change from baseline to one month post-treatment (10 weeks) | |
Secondary | Relationship satisfaction as measured by Relationship Assessment Scale | (Hendrick, 1988)7-item questionnaire | Change from baseline to four months post-treatment (22 weeks) |