Recruiting

Mindfulness

Sponsor:

Vancouver Coastal Health

Code:

NCT04341025

Conditions

Situational Erectile Dysfunction

Eligibility Criteria

Sex: Male

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Mindfulness based psychosexual therapy ( MBPST)

Study Details

Brief 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.

Conditions

Situational Erectile Dysfunction

Study ID

NCT04341025

Start date

Apr 14, 2020

Status verified date

Oct, 2022

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Single Arm

Patients are compared to themselves before and after the treatment.

Interventions

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.

Primary outcome measure

  • Self-reported Erectile Functioning as measured by International Index of Erectile Function - 5 [ Time Frame: Change from baseline to immediately post treatment (6 weeks) ]
  • Self-reported Erectile Functioning as measured by International Index of Erectile Function - 5 [ Time Frame: Change from baseline to one month post-treatment (10 weeks) ]
  • Self-reported Erectile Functioning as measured by International Index of Erectile Function - 5 [ Time Frame: Change from baseline to four months post-treatment (22 weeks) ]
  • Self-reported Sexual Distress as measured by Sexual Distress Scale-Revised [ Time Frame: Change from baseline to immediately post treatment (6 weeks) ]
  • Self-reported Sexual Distress as measured by Sexual Distress Scale-Revised [ Time Frame: Change from baseline to one month post-treatment (10 weeks) ]
  • Self-reported Sexual Distress as measured by Sexual Distress Scale-Revised [ Time Frame: Change from baseline to four months post-treatment (22 weeks) ]
  • Self-reported Confidence in Sexual and Erectile Competence as measured by Sexual Self-Efficacy Scale - Erectile Functioning [ Time Frame: Change from baseline to immediately post treatment (6 weeks) ]
  • Self-reported Confidence in Sexual and Erectile Competence as measured by Sexual Self-Efficacy Scale - Erectile Functioning [ Time Frame: Change from baseline to one month post-treatment (10 weeks) ]
  • Self-reported Confidence in Sexual and Erectile Competence as measured by Sexual Self-Efficacy Scale - Erectile Functioning [ Time Frame: Change from baseline to four months post-treatment (22 weeks) ]
  • Self-reported Sexual Satisfaction and Pleasure as measured by International Index of Erectile Function - Overall Satisfaction Subscale. [ Time Frame: Change from baseline to immediately post treatment (6 weeks) ]
  • Self-reported Sexual Satisfaction and Pleasure as measured by International Index of Erectile Function - Overall Satisfaction Subscale [ Time Frame: Change from baseline to one month post-treatment (10 weeks) ]
  • Self-reported Sexual Satisfaction and Pleasure as measured by International Index of Erectile Function - Overall Satisfaction Subscale [ Time Frame: Change from baseline to four months post-treatment (22 weeks) ]
  • Self-reported Sexual Pleasure as measured by an investigator-created Questionnaire [ Time Frame: Change from baseline to immediately post treatment (6 weeks) ]
  • Self-reported Sexual Pleasure as measured by an investigator-created Questionnaire [ Time Frame: Change from baseline to one month post-treatment (10 weeks) ]
  • Self-reported Sexual Pleasure as measured by an investigator-created Questionnaire [ Time Frame: Change from baseline to four months post-treatment (22 weeks) ]

Central Contacts and Locations

Central contacts

Shauna Correia, MD

604-875-4705shauna.correia@vch.ca

Miriam Driscoll, MD

604-875-4705miriam.driscoll@vch.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

More Information

Sponsor

Vancouver Coastal Health

Last update posted

Oct 19, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vancouver Coastal Health on 2022-10-19.