Back to resultsA Mindfulness-based Intervention for Older Women With Low Sexual Desire
Primary Purpose
Hypoactive Sexual Desire Disorder, Sexual Dysfunction, Female Sexual Dysfunction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mindfulness-based multicomponent intervention
general health education group
Sponsored by
About this trial
This is an interventional other trial for Hypoactive Sexual Desire Disorder focused on measuring hypoactive sexual desire disorder, female sexual dysfunction, low libido, female sexual interest-arousal disorder, low desire, sexual dysfunction
Eligibility Criteria
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)
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
mindfulness group
educational group
Arm Description
A multicomponent group-based intervention rooted in mindfulness, administered in 3 sessions over 6 weeks
A general midlife health and aging educational group, administered in 3 sessions over 6 weeks
Outcomes
Primary Outcome Measures
Feasibility - Number of Enrolled Women Participating in All Sessions
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
Number of women indicating "somewhat" or "very satisfied" on a 5-point Likert scale measure of intervention satisfaction
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03232801
First Posted
March 10, 2017
Last Updated
October 11, 2022
Sponsor
University of Pittsburgh
Collaborators
National Institute on Aging (NIA), National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT03232801
Brief Title
A Mindfulness-based Intervention for Older Women With Low Sexual Desire
Official Title
A Mindfulness-based Intervention for Older Women With Low Sexual Desire
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 8, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Aging (NIA), National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoactive Sexual Desire Disorder, Sexual Dysfunction, Female Sexual Dysfunction
Keywords
hypoactive sexual desire disorder, female sexual dysfunction, low libido, female sexual interest-arousal disorder, low desire, sexual dysfunction
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mindfulness group
Arm Type
Experimental
Arm Description
A multicomponent group-based intervention rooted in mindfulness, administered in 3 sessions over 6 weeks
Arm Title
educational group
Arm Type
Active Comparator
Arm Description
A general midlife health and aging educational group, administered in 3 sessions over 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
mindfulness-based multicomponent intervention
Intervention Description
A group-based, multicomponent behavioral intervention rooted in mindfulness
Intervention Type
Behavioral
Intervention Name(s)
general health education group
Intervention Description
A general health and aging education group
Primary Outcome Measure Information:
Title
Feasibility - Number of Enrolled Women Participating in All Sessions
Description
Number of enrolled women participating in all sessions
Time Frame
6 weeks
Title
Acceptability - Number of Women Indicating "Somewhat" or "Very Satisfied" on a 5-point Likert Scale Measure of Intervention Satisfaction
Description
Number of women indicating "somewhat" or "very satisfied" on a 5-point Likert scale measure of intervention satisfaction
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in FSFI Desire Score
Description
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.
Time Frame
Baseline and 12 weeks
Other Pre-specified Outcome Measures:
Title
Change in Overall Sexual Function
Description
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.
Time Frame
Baseline and 12 weeks
Title
Comprehensive Sexual Desire
Description
Sexual Interest and Desire Inventory (SIDI)
Time Frame
6 weeks and 12 weeks
Title
Sexual Distress
Description
Female Sexual Distress Scale - Revised (FSDS-R)
Time Frame
6 weeks and 12 weeks
Title
Quality of Life - SF 36
Description
Quality of life as measured by Short Form-36 (SF-36)
Time Frame
6 weeks and 12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
women participants only
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Mindfulness-based Intervention for Older Women With Low Sexual Desire
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