Providing Insight Into and Mindfulness for Situational Erectile Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Self-reported Sexual Distress as measured by Sexual Distress Scale-Revised
研究概览
简要总结
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.
详细描述
PURPOSE The purpose of this study is to assess the feasibility and efficacy of a 6-session mindfulness-based psychosexual therapy (MBPST) treatment protocol using self-report questionnaires. The current protocol is adapted from a pre-existing 4-session mindfulness-based psychosexual therapy (MBPST) protocol from a pilot study which has already demonstrated benefits in the treatment of situational erectile dysfunction (ED). The six sessions include elements of psychoeducation, cognitive therapy, mindfulness training, and sex therapy techniques. The elements comprising the six sessions are evidence-based, as their effectiveness has been demonstrated in female samples (e.g., Brotto et al., 2012; Paterson et al., 2017), and more recently in the context of a four-session pilot in men with situational ED (H15-03172; published in Bossio et al., 2018). The rationale for an increase from a 4 to 6-session approach came from qualitative analysis of participant perspectives in the pilot study and from investigator experience.
HYPOTHESES
- Men who undergo MBPST treatment will show significant post-treatment improvements at follow-up (immediately following treatment and at 1- and 4-months after treatment completion), compared to baseline, to primary endpoints of: (i) erectile functioning; (ii) sexual distress; (iii) sexual satisfaction and pleasure.
- Men who undergo MBPST treatment will show significant post-treatment improvements at follow-up (immediately following treatment and at 1- and 4-months after treatment completion), compared to baseline, to secondary endpoints of: (i) psychological variables/mental status (i.e., anxiety); (ii) mindfulness-related variables; and (iii) relationship satisfaction. The role of secondary endpoints as mediators to primary endpoints of sexual functioning will also be assessed.
- Men will report significantly less use of medications for ED (i.e., PDE5 inhibitors and intracavernosal injections) at 4-month follow-up compared to pre-treatment.
JUSTIFICATION Sexual dysfunction affects at least one third of men across the lifespan (Laumann, Paik, & Rosen, 1999), and can have significant impact on quality of life and on intimate relationships (Hatzimouratidis et al., 2010). Erectile dysfunction (ED), or the inability to attain and/or maintain an erection sufficient for satisfactory sexual activity (NIH, 1993), is among the most common sexual dysfunctions experienced by men. The aetiology of ED is complex and can result from a variety of physiological (e.g., age, cardiovascular health, medication use), psychological (e.g., anxiety), and lifestyle factors (e.g., smoking status; Nicolosi, Moreira, Shirai, Tambi, & Glasser, 2003). Situational ED refers to ED that occurs in certain contexts (e.g., with a partner), but not others (e.g., masturbation, nocturnal erections).
Although pharmacological interventions (i.e., PDE5 inhibitors) have been available to treat ED since the 1990's, adherence to these treatments is poor, with approximately 50% of men failing to re-fill their first prescription (Carvalheira, Pereira, Maroco, & Forjaz, 2012; Hanash, 1997), despite the restoration of erections (Giannitsas, Konstantinopoulos, Patsialas, & Perimenis, 2008). This low adherence to pharmacological treatments suggests that there are aspects of ED, beyond the rigidity of erections that are not being addressed by medications. This may be particularly true in the case of situational ED, where psychogenic factors are playing a major role (McCabe et al., 2016).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Single Arm
Patients are compared to themselves before and after the treatment.
干预措施: Mindfulness based psychosexual therapy ( MBPST) (Behavioral)
结局指标
主要结局
Self-reported Sexual Distress as measured by Sexual Distress Scale-Revised
时间窗: Change from baseline to four months post-treatment (22 weeks)
(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
Self-reported Sexual Pleasure as measured by an investigator-created Questionnaire
时间窗: Change from baseline to four months post-treatment (22 weeks)
2-item self report questionnaire on a 5-point scale assessing physical and emotional sexual pleasure.
Self-reported Erectile Functioning as measured by International Index of Erectile Function - 5
时间窗: Change from baseline to four months post-treatment (22 weeks)
(IIEF-5; Rosen, Cappelleri, Smith, Lipsky, \& Pena, 1999); 5 item questionnaire
Self-reported Sexual Satisfaction and Pleasure as measured by International Index of Erectile Function - Overall Satisfaction Subscale.
时间窗: Change from baseline to immediately post treatment (6 weeks)
(Rosen, Riley, Wagner, Osterloh, Kirkpatrick, \& Mishra, 1997), which measures sexual satisfaction. 2-item questionnaire
Self-reported Sexual Satisfaction and Pleasure as measured by International Index of Erectile Function - Overall Satisfaction Subscale
时间窗: Change from baseline to four months post-treatment (22 weeks)
(Rosen, Riley, Wagner, Osterloh, Kirkpatrick, \& Mishra, 1997), which measures sexual satisfaction. 2-item questionnaire
Self-reported Confidence in Sexual and Erectile Competence as measured by Sexual Self-Efficacy Scale - Erectile Functioning
时间窗: Change from baseline to four months post-treatment (22 weeks)
(Fichten, Spector, Amsel, Creti, Brender, \& Libman, 1998), which measures confidence in sexual and erectile competence; 25 item rating scale
Self-reported Erectile Functioning as measured by International Index of Erectile Function - 5
时间窗: Change from baseline to immediately post treatment (6 weeks)
(IIEF-5; Rosen, Cappelleri, Smith, Lipsky, \& Pena, 1999); 5 item questionnaire
Self-reported Erectile Functioning as measured by International Index of Erectile Function - 5
时间窗: Change from baseline to one month post-treatment (10 weeks)
(IIEF-5; Rosen, Cappelleri, Smith, Lipsky, \& Pena, 1999); 5 item questionnaire
Self-reported Sexual Distress as measured by Sexual Distress Scale-Revised
时间窗: Change from baseline to immediately post treatment (6 weeks)
(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
Self-reported Sexual Distress as measured by Sexual Distress Scale-Revised
时间窗: Change from baseline to one month post-treatment (10 weeks)
(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
Self-reported Confidence in Sexual and Erectile Competence as measured by Sexual Self-Efficacy Scale - Erectile Functioning
时间窗: Change from baseline to immediately post treatment (6 weeks)
(Fichten, Spector, Amsel, Creti, Brender, \& Libman, 1998), which measures confidence in sexual and erectile competence; 25 item rating scale
Self-reported Confidence in Sexual and Erectile Competence as measured by Sexual Self-Efficacy Scale - Erectile Functioning
时间窗: Change from baseline to one month post-treatment (10 weeks)
(Fichten, Spector, Amsel, Creti, Brender, \& Libman, 1998), which measures confidence in sexual and erectile competence; 25 item rating scale
Self-reported Sexual Satisfaction and Pleasure as measured by International Index of Erectile Function - Overall Satisfaction Subscale
时间窗: Change from baseline to one month post-treatment (10 weeks)
(Rosen, Riley, Wagner, Osterloh, Kirkpatrick, \& Mishra, 1997), which measures sexual satisfaction. 2-item questionnaire
Self-reported Sexual Pleasure as measured by an investigator-created Questionnaire
时间窗: Change from baseline to immediately post treatment (6 weeks)
2-item self report questionnaire on a 5-point scale assessing physical and emotional sexual pleasure.
Self-reported Sexual Pleasure as measured by an investigator-created Questionnaire
时间窗: Change from baseline to one month post-treatment (10 weeks)
2-item self report questionnaire on a 5-point scale assessing physical and emotional sexual pleasure.
次要结局
- Non-attachment mindfulness skill as measured by Nonattachment Scale-7(Change from baseline to four months post-treatment (22 weeks))
- Relationship satisfaction as measured by Relationship Assessment Scale(Change from baseline to four months post-treatment (22 weeks))
- Anxiety Symptoms as measured by Generalized Anxiety Disorder-7(Change from baseline to four months post-treatment (22 weeks))
- Degree of Mindfulness as measured by the Five Facet Mindfulness Questionnaire-15(Change from baseline to four months post-treatment (22 weeks))
- Anxiety Symptoms as measured by Generalized Anxiety Disorder-7(Change from baseline to immediately post treatment (6 weeks))
- Anxiety Symptoms as measured by Generalized Anxiety Disorder-7(Change from baseline to one month post-treatment (10 weeks))
- Degree of Mindfulness as measured by the Five Facet Mindfulness Questionnaire-15(Change from baseline to immediately post treatment (6 weeks))
- Degree of Mindfulness as measured by the Five Facet Mindfulness Questionnaire-15(Change from baseline to one month post-treatment (10 weeks))
- Non-attachment mindfulness skill as measured by Nonattachment Scale-7(Change from baseline to immediately post treatment (6 weeks))
- Non-attachment mindfulness skill as measured by Nonattachment Scale-7(Change from baseline to one month post-treatment (10 weeks))
- Relationship satisfaction as measured by Relationship Assessment Scale(Change from baseline to immediately post treatment (6 weeks))
- Relationship satisfaction as measured by Relationship Assessment Scale(Change from baseline to one month post-treatment (10 weeks))
研究者
Miriam Driscoll
PI
Vancouver Coastal Health