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Mindfulness-Based Therapy for Erectile Dysfunction (PRIMED Trial)

N/A

Recruiting

Led By Miriam Driscoll, MD

Research Sponsored by Vancouver Coastal Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

19 years of age or older

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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to four months post-treatment (22 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a 6-session mindfulness-based therapy group will help men with erectile dysfunction who have poor adherence to pharmacological treatments.

Who is the study for?

This trial is for men over 19 with situational erectile dysfunction (ED) lasting at least 6 months, who are comfortable in small groups and can communicate in English. Participants must not use ED medications from the start until 10 weeks into the study and should have no unmanaged health or severe mental conditions.

What is being tested?

The trial tests a mindfulness-based psychosexual therapy (MBPST) across six sessions to see if it helps men with situational ED. It builds on a previous successful protocol, measuring outcomes through questionnaires about sexual function, relationship satisfaction, and treatment acceptability.

What are the potential side effects?

Since MBPST involves psychological therapy rather than medication, typical side effects associated with drugs may not apply. However, participants might experience emotional discomfort or distress during therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 19 years old or older.

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I have been diagnosed with situational ED for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have uncontrolled health or severe mental health issues affecting my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to four months post-treatment (22 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to four months post-treatment (22 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to four months post-treatment (22 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Self-reported Confidence in Sexual and Erectile Competence as measured by Sexual Self-Efficacy Scale - Erectile Functioning

Self-reported Erectile Functioning as measured by International Index of Erectile Function - 5

Self-reported Sexual Distress as measured by Sexual Distress Scale-Revised

+3 more

Secondary study objectives

Anxiety Symptoms as measured by Generalized Anxiety Disorder-7

Degree of Mindfulness as measured by the Five Facet Mindfulness Questionnaire-15

Non-attachment mindfulness skill as measured by Nonattachment Scale-7

+1 more

Other study objectives

Mindfulness and Sexual Activities Practice as measured by investigator-created questionnaire

PDE5 inhibitor Medication Use

Patient Satisfaction towards therapy group and Self-reported Impact on Quality of Sexual Life as measured by Patient Global Impression of Change Scale - Revised