A Mindfulness-based Intervention for Older Women With Low Sexual Desire

Sexual Dysfunction Clinical Trial

Official title:

A Mindfulness-based Intervention for Older Women With Low Sexual Desire

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03232801
• Other study ID #: PRO15060240
• Secondary ID: K23AG052628
• Status: Completed
• Phase: N/A
• Start date: October 8, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: October 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall aim of this research is to adapt and pilot test a multi-component, mindfulness-based behavioral intervention for women age 50 and older with low sexual desire.

Description:

Specifically, the investigators will conduct a pilot randomized controlled trial to assess the feasibility, acceptability, and preliminary efficacy of the intervention. Fifty women will be randomized to the mindfulness intervention or an educational control group. Both groups will be conducted in 3 sessions over 6 weeks in groups of 10 women. Feasibility, acceptability, facilitators, and barriers will be assessed by surveys after each session and after intervention completion. Preliminary efficacy will be assessed by measures of sexual desire, sexual function, and overall sexual satisfaction at 6 and 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• meet criteria for a diagnosis of Female Sexual Interest/Arousal Disorder

• English-speaking

• have a current sexual partner with whom they are or would like to be sexually active

Exclusion Criteria:

• active major depression

• active substance abuse

• current intimate partner violence

• partner with active major depression

• partner with active major substance abuse

• significant relationship dissatisfaction

• current use of antidepressants

• untreated dyspareunia (sexual pain)

Related Conditions & MeSH terms

• Female Sexual Dysfunction
• Hypoactive Sexual Desire Disorder
• Hypokinesia
• Sexual Dysfunction
• Sexual Dysfunctions, Psychological

Intervention

Behavioral:
• mindfulness-based multicomponent intervention
A group-based, multicomponent behavioral intervention rooted in mindfulness
• general health education group
A general health and aging education group

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Overall Sexual Function	Total Female Sexual Function Index (FSFI) score from baseline to 12 weeks. The FSFI score can range from 2.0 to 36.0, and a higher score indicates worse sexual function.	Baseline and 12 weeks
Other	Comprehensive Sexual Desire	Sexual Interest and Desire Inventory (SIDI)	6 weeks and 12 weeks
Other	Sexual Distress	Female Sexual Distress Scale - Revised (FSDS-R)	6 weeks and 12 weeks
Other	Quality of Life - SF 36	Quality of life as measured by Short Form-36 (SF-36)	6 weeks and 12 weeks
Primary	Feasibility - Number of Enrolled Women Participating in All Sessions	Number of enrolled women participating in all sessions	6 weeks
Primary	Acceptability - Number of Women Indicating "Somewhat" or "Very Satisfied" on a 5-point Likert Scale Measure of Intervention Satisfaction	Number of women indicating "somewhat" or "very satisfied" on a 5-point Likert scale measure of intervention satisfaction	6 weeks
Secondary	Change in FSFI Desire Score	Change in Female Sexual Function Index (FSFI) desire score from baseline to 12 weeks. The FSFI Desire score is a subscale of the FSFI. Scores range from 1.0 to 5.0, with higher scores indicating worse sexual desire. Minimum score is 1.0 and maximum score is 5.0.	Baseline and 12 weeks