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

Not Applicable

Completed

• Conditions: Hypoactive Sexual Desire Disorder; Female Sexual Dysfunction; Sexual Dysfunction
• Interventions: Behavioral: general health education group; Behavioral: mindfulness-based multicomponent intervention

• Registration Number: NCT03232801
• Lead Sponsor: University of Pittsburgh

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-28
• Study Start: 2020-10-08
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Results First Submitted: 2022-08-16
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-11
• Last Update Submitted: 2022-10-11
• Results First Posted: 2022-10-13
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
educational group	general health education group	A general midlife health and aging educational group, administered in 3 sessions over 6 weeks
mindfulness group	mindfulness-based multicomponent intervention	A multicomponent group-based intervention rooted in mindfulness, administered in 3 sessions over 6 weeks

Primary Outcome Measures

Name	Time	Method
Feasibility - Number of Enrolled Women Participating in All Sessions	6 weeks	Number of enrolled women participating in all sessions
Acceptability - Number of Women Indicating "Somewhat" or "Very Satisfied" on a 5-point Likert Scale Measure of Intervention Satisfaction	6 weeks	Number of women indicating "somewhat" or "very satisfied" on a 5-point Likert scale measure of intervention satisfaction

Secondary Outcome Measures

Name	Time	Method
Change in FSFI Desire Score	Baseline and 12 weeks	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.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States