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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

PRIMED Trial 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.Check my eligibility

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.See study design

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.

PRIMED Trial 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.

PRIMED Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

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

PRIMED Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Patients are compared to themselves before and after the treatment.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vancouver Coastal HealthLead Sponsor

37 Previous Clinical Trials

711,852 Total Patients Enrolled

Miriam Driscoll, MDPrincipal InvestigatorUBC

Media Library

Mindfulness based psychosexual therapy ( MBPST) Clinical Trial Eligibility Overview. Trial Name: NCT04341025 — N/A

Erectile Dysfunction Research Study Groups: Single Arm

Erectile Dysfunction Clinical Trial 2023: Mindfulness based psychosexual therapy ( MBPST) Highlights & Side Effects. Trial Name: NCT04341025 — N/A

Mindfulness based psychosexual therapy ( MBPST) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04341025 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aims does this trial seek to accomplish?

"The principal evaluation of this trial, conducted over a 22 week period from the baseline to post-treatment, will assess patients' Self-reported Confidence in Sexual and Erectile Competence with the Sexual Self-Efficacy Scale. Secondary metrics include Nonattachment Scale - 7 which evaluates mindfulness levels (Sahdra et al., 2015), Relationship Assessment Scale for assessing relationship satisfaction (Hendrick 1988), and Five Facet Mindfulness Questionnaire - 15 to gauge degree of mindfulness skills (Baer et al., 2012; Gu et al., 2016)."

Answered by AI

How many participants are currently engaged in this research project?

"Affirmative. According to information found on clinicaltrials.gov, this research program is currently looking for participants and was first published April 14th 2020. The study requires 60 subjects at a single site and was most recently edited October 17th 2022."

Answered by AI

Are individuals eligible to join this experiment at the moment?

"Affirmative. Clinicaltrials.gov data suggests that this clinical trial, which was first posted on April 14th 2020, is presently recruiting participants. Approximately 60 patients need to be enlisted from a single testing site."

Answered by AI

Recent research and studies

The Journal of Sexual MedicineJournal

Mindfulness-based Group Therapy for Men with Situational Erectile Dysfunction: A Mixed-methods Feasibility Analysis and Pilot Study

Bossio, Jennifer A., Rosemary Basson, Miriam Driscoll, Shauna Correia, and Lori A. Brotto. 2018. “Mindfulness-based Group Therapy for Men with Situational Erectile Dysfunction: A Mixed-methods Feasibility Analysis and Pilot Study”. The Journal of Sexual Medicine. Elsevier BV. doi:10.1016/j.jsxm.2018.08.013.

clinicaltrials.govStudy

Providing Insight Into and Mindfulness for Situational Erectile Dysfunction

Miriam Driscoll 2020. "Providing Insight Into and Mindfulness for Situational Erectile Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04341025.

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