Providing Insight Into and Mindfulness for Situational Erectile Dysfunction

Situational Erectile Dysfunction Clinical Trial

— PRIMED  

Official title:

Providing Insight Into and Mindfulness for Situational Erectile Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04341025
• Other study ID #: H18-00665
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2020
• Est. completion date: December 2024

Study information

• Verified date: October 2022
• Source: Vancouver Coastal Health
• Contact: Shauna Correia, MD
• Phone: 604-875-4705
• Email: shauna.correia[@]vch.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

1. 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.

2. 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.

3. 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).

There is increasing evidence documenting the benefits of MBCT for women with sexual dysfunction (Brotto, Basson, & Luria, 2008; Brotto et al., 2008; Brotto et al., 2012; Brotto, Seal, & Rellini, 2012; Brotto & Basson, 2014; Paterson, Handy, & Brotto, 2017). Further, the investigators recently adapted a pre-existing 4-session MBPST protocol, which had already been shown to be effective in the treatment of female sexual dysfunction, to fit the needs of men with situational ED and pilot-tested it in group format (H15-03172). Our pilot data suggest significant benefits for men with situational ED (Bossio, Basson, Driscoll, Correia, & Brotto, 2019). However, feedback from the pilot participants indicated a need for additional sessions as they had only begun to establish a regular mindfulness practice. Mindfulness-based interventions consisting of eight sessions are common and have been shown to be effective in reducing depressive symptoms (Sipe & Eisendrath, 2012), depressive relapse (Teasdale, Segal, Williams, Ridgeway, Soulsby, & Lau, 2000), and anxiety (Evans, Ferrando, Findler, Stowell, Smart, & Haglin, 2008). However, the investigators were skeptical about the willingness and ability of patients to commit to eight consecutive weeks of treatment. Therefore, the current project is a pilot study intended to assess the feasibility and efficacy of a 6-session MBPST program for situational ED.

OBJECTIVES The main objective of this study is to test the feasibility and efficacy of a 6-session MBPST protocol for men with situational ED. Specifically, the investigators hope to find that men who undergo this treatment will experience improvements in primary (e.g., decreased erectile dysfunction and sexual distress), and secondary endpoints (e.g., increased relationship satisfaction and mental well-being). Further, the investigators hope to find that gains in the primary and secondary endpoints are maintained at 1- and 4-months.

RESEARCH DESIGN Participants (N=60) will take part in a 6-session MBPST group (n=6-10) for treatment of situational ED, either in-person or in an online format. Each session will be 2 hours in length and will be spaced one week apart, for a total of 12 hours of treatment time. Participants will also take part in supportive group follow-up sessions at 1- and 4-months following group completion where participants are free to share their experiences with the group, ask questions, and participate in troubleshooting. Treatment endpoints will be assessed at four time-points (pre-treatment (Time 1), immediate post-treatment (Time 2), 1-month post-treatment (Time 3), and 4-months post-treatment (Time 4)).

STATISTICAL ANALYSIS One-way repeated-measures multivariate analysis of variance (MANOVA) will be used to assess our primary hypothesis-that men will show improvements in primary (i.e., sexual functioning) endpoints following treatment-with the primary endpoint measures as the dependent variables (e.g., ED severity, sexual distress, sexual satisfaction, pleasure), time-point (pre-treatment, immediate post-treatment, 1-month post-treatment, and 4-months post-treatment) as the independent variable, and age as a covariate.

Our secondary hypotheses-that men will show improvements secondary endpoints (i.e., mindfulness-related variables, mental status, and relationship factors) following treatment-will also be examined using the same repeated-measures MANOVA strategy described above. The hypothesis that secondary endpoints act as mediators of sexual functioning following treatment will also be examined using repeated-measures ANOVAs with primary endpoint measures as the dependent variable (i.e., sexual functioning), time-point (pre-treatment, immediate post-treatment, 1-month post-treatment, and 4-months post-treatment) as the independent variable, and secondary endpoints (e.g., change in relationship satisfaction) as mediators.

Our tertiary hypothesis-that men will report using medications for ED significantly less 4-months after treatment conclusion compared with pre-treatment use-will be assessed using paired-sample t-tests comparing frequency of use and dose before treatment and 4-months after treatment.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Situational Erectile Dysfunction

Intervention

Behavioral:
• Mindfulness based psychosexual therapy ( MBPST)
The group treatment sessions will integrate empirically supported elements of psychoeduation, cognitive behavioural therapy, and mindfulness skills. Each of the six sessions will follow the well-defined manualized treatment protocol. The treatment is adapted from the study team's previous mindfulness-based treatment group (H15-03172), for situational ED which has been shown to be effective. Participants will be provided with handouts and asked to complete approximately 10-60 minutes/day of at-home practice/skills, which may include reading material, mindfulness exercises, and/or behavioural exercises between sessions. During the 2 follow-up sessions, participants will be invited to share their experience since the conclusion of group, ask questions, and participate in troubleshooting.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Vancouver Coastal Health

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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

Outcome

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)