A Mindfulness-based Intervention for Older Women With Low Sexual Desire
2 other identifiers
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2017
CompletedFirst Posted
Study publicly available on registry
July 28, 2017
CompletedStudy Start
First participant enrolled
October 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedResults Posted
Study results publicly available
October 13, 2022
CompletedOctober 13, 2022
October 1, 2022
11 months
March 10, 2017
August 16, 2022
October 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Change in FSFI Desire Score
Baseline and 12 weeks
Other Outcomes (4)
Change in Overall Sexual Function
Baseline and 12 weeks
Comprehensive Sexual Desire
6 weeks and 12 weeks
Sexual Distress
6 weeks and 12 weeks
- +1 more other outcomes
Study Arms (2)
mindfulness group
EXPERIMENTALA multicomponent group-based intervention rooted in mindfulness, administered in 3 sessions over 6 weeks
educational group
ACTIVE COMPARATORA general midlife health and aging educational group, administered in 3 sessions over 6 weeks
Interventions
A group-based, multicomponent behavioral intervention rooted in mindfulness
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- National Institute on Aging (NIA)collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Holly Thomas
- Organization
- University of Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
March 10, 2017
First Posted
July 28, 2017
Study Start
October 8, 2020
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
October 13, 2022
Results First Posted
October 13, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share