Providing Insight Into and Mindfulness for Situational Erectile Dysfunction

NCT04341025 | Unknown

• 1 other identifier: H18-00665
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (15)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (12)

• 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)

• 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 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)

Other Outcomes (9)

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

  Change from baseline to immediately post treatment (6 weeks)

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

  Change from baseline to one month post-treatment (10 weeks)

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

  Change from baseline to four months post-treatment (22 weeks)

Study Arms (1)

Single Arm

OTHER

Patients are compared to themselves before and after the treatment.

Behavioral: Mindfulness based psychosexual therapy ( MBPST)

Interventions

Mindfulness based psychosexual therapy ( MBPST) BEHAVIORAL

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.

Also known as: MBCT ( Mindfulness based cognitive therapy )

Single Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vancouver Coastal Health: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Related 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.2018.08.013.

  PMID: 30297094 RESULT

MeSH Terms

Interventions

Mindfulness-Based Cognitive Therapy

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Miriam Driscoll, MD

  UBC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shauna Correia, MD

CONTACT

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

Miriam Driscoll, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: Participants will take part in a 6-session MBPST group for treatment of situational ED. 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. Treatment endpoints will be assessed at four time-points (pre-treatment, immediate post-treatment, 1-month post-treatment, and 4-months post-treatment).

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: April 10, 2020
• Study Start: April 14, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)