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

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.

Study Overview

• Status: Completed
• Conditions: Sexual Dysfunction; Female Sexual Dysfunction; Hypoactive Sexual Desire Disorder
• Intervention / Treatment: Behavioral: mindfulness-based multicomponent intervention; Behavioral: general health education group

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: mindfulness group; A multicomponent group-based intervention rooted in mindfulness, administered in 3 sessions over 6 weeks	Behavioral: mindfulness-based multicomponent intervention; A group-based, multicomponent behavioral intervention rooted in mindfulness
ACTIVE_COMPARATOR: educational group; A general midlife health and aging educational group, administered in 3 sessions over 6 weeks	Behavioral: general health education group; A general health and aging education group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - Number of Enrolled Women Participating in All Sessions	Number of enrolled women participating in all sessions	6 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Comprehensive Sexual Desire	Sexual Interest and Desire Inventory (SIDI)	6 weeks and 12 weeks
Sexual Distress	Female Sexual Distress Scale - Revised (FSDS-R)	6 weeks and 12 weeks
Quality of Life - SF 36	Quality of life as measured by Short Form-36 (SF-36)	6 weeks and 12 weeks

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institutes of Health (NIH); National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 8, 2020
• Primary Completion (ACTUAL): September 1, 2021
• Study Completion (ACTUAL): September 1, 2021

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (ACTUAL): July 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: sexual dysfunction; female sexual dysfunction; low libido; hypoactive sexual desire disorder; female sexual interest-arousal disorder; low desire
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Hypokinesia; Sexual Dysfunctions, Psychological
• Other Study ID Numbers: PRO15060240; K23AG052628 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No