Skip to main content
OpenTrials
Completed

NCT Number: NCT03232801

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypoactive Sexual Desire Disorder Female Sexual Dysfunction Genital Diseases Mental Disorders Sexual Dysfunction Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

mindfulness-based multicomponent intervention

Behavioral

A group-based, multicomponent behavioral intervention rooted in mindfulness

general health education group

Behavioral

A general health and aging education group

Primary outcomes

  1. Feasibility - Number of Enrolled Women Participating in All Sessions

    Time frame: 6 weeks

    Number of enrolled women participating in all sessions

  2. Acceptability - Number of Women Indicating "Somewhat" or "Very Satisfied" on a 5-point Likert Scale Measure of Intervention Satisfaction

    Time frame: 6 weeks

    Number of women indicating "somewhat" or "very satisfied" on a 5-point Likert scale measure of intervention satisfaction

Secondary outcomes

  1. Change in FSFI Desire Score

    Time frame: 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.

Other outcomes

  1. Change in Overall Sexual Function

    Time frame: Baseline and 12 weeks

    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.

  2. Comprehensive Sexual Desire

    Time frame: 6 weeks and 12 weeks

    Sexual Interest and Desire Inventory (SIDI)

  3. Sexual Distress

    Time frame: 6 weeks and 12 weeks

    Female Sexual Distress Scale - Revised (FSDS-R)

  4. Quality of Life - SF 36

    Time frame: 6 weeks and 12 weeks

    Quality of life as measured by Short Form-36 (SF-36)

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 28, 2017
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.