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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03232801
Enrollment
62
Registered
2017-07-28
Start date
2020-10-08
Completion date
2021-09-01
Last updated
2022-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Sexual Dysfunction, Hypoactive Sexual Desire Disorder, Sexual Dysfunction

Keywords

hypoactive sexual desire disorder, female sexual dysfunction, low libido, female sexual interest-arousal disorder, low desire, sexual dysfunction

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.

Interventions

BEHAVIORALmindfulness-based multicomponent intervention

A group-based, multicomponent behavioral intervention rooted in mindfulness

BEHAVIORALgeneral health education group

A general health and aging education group

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
National Institutes of Health (NIH)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Feasibility - Number of Enrolled Women Participating in All Sessions6 weeksNumber 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 Satisfaction6 weeksNumber of women indicating somewhat or very satisfied on a 5-point Likert scale measure of intervention satisfaction

Secondary

MeasureTime frameDescription
Change in FSFI Desire ScoreBaseline and 12 weeksChange 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

MeasureTime frameDescription
Change in Overall Sexual FunctionBaseline and 12 weeksTotal 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.
Quality of Life - SF 366 weeks and 12 weeksQuality of life as measured by Short Form-36 (SF-36)
Comprehensive Sexual Desire6 weeks and 12 weeksSexual Interest and Desire Inventory (SIDI)
Sexual Distress6 weeks and 12 weeksFemale Sexual Distress Scale - Revised (FSDS-R)

Countries

United States

Participant flow

Pre-assignment details

81 women were screened. 19 women were ineligible (N=62 enrolled). One woman withdrew after consent but before randomization. N=61 women were randomized.

Participants by arm

ArmCount
Mindfulness
A six-session mindfulness-based intervention focused on sexual health and function. Groups met weekly for 1.5-2 hours over the course of six weeks. Groups were co-led by a primary care physician (the primary investigator) and a trained mindfulness instructor with over 10 years of experience in mindfulness meditation instruction. The intervention contained elements of mindfulness-based stress reduction and sexual psychoeducation. Intervention components including instruction in mindfulness meditation, body scan, awareness of breathing, mindful yoga, and loving kindness meditation, as well as application of these practices to sexual function. At least 30 minutes of each session were spent in mindfulness practice. Sessions also included group discussions and break-out rooms to facilitate discussinos about the practice. Based on prior qualitative research, the intervention also included information about partner sexual dysfunction, body image, and how menopause can affect sexuality. Participants were encouraged to do 60 minutes of mindfulness home practice daily and were provided with audio recordings to facilitate home practice. Home practice included sexuality-specific mindfulness exercises.
28
Education
The control condition was a six-session health education intervention. Groups met weekly for 1.5-2 hours over the course of six weeks. Groups were led by a primary care physician (the primary investigator) alone. The control intervention covered general educational topics relevant to the health of midlife women, such as osteoporosis and heart disease. Sexual health was discussed in one session, but not in detail. At the conclusion of their participation in the group, control group participants were given a brochure with local resources for learning about mindfulness meditation. Participants did not have any homework to complete for this group.
27
Total55

Baseline characteristics

CharacteristicEducationMindfulnessTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants3 Participants6 Participants
Age, Categorical
Between 18 and 65 years
24 Participants25 Participants49 Participants
Age, Continuous55.7 years
STANDARD_DEVIATION 7.5
55.9 years
STANDARD_DEVIATION 7.1
55.8 years
STANDARD_DEVIATION 7.3
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
27 Participants27 Participants54 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Female Sexual Distress Scale - Revised (FSDS-R)18.5 units on a scale
STANDARD_DEVIATION 8.8
23.3 units on a scale
STANDARD_DEVIATION 11.9
20.7 units on a scale
STANDARD_DEVIATION 10.6
Female Sexual Function Index (FSFI)20.5 units on a scale
STANDARD_DEVIATION 7.3
21.1 units on a scale
STANDARD_DEVIATION 6.1
20.7 units on a scale
STANDARD_DEVIATION 6.7
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants3 Participants3 Participants
Race (NIH/OMB)
Black or African American
3 Participants2 Participants5 Participants
Race (NIH/OMB)
More than one race
0 Participants3 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
24 Participants20 Participants44 Participants
Region of Enrollment
United States
27 participants28 participants55 participants
Sex: Female, Male
Female
27 Participants28 Participants55 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 310 / 30
other
Total, other adverse events
0 / 310 / 30
serious
Total, serious adverse events
0 / 310 / 30

Outcome results

Primary

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

Time frame: 6 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
MindfulnessAcceptability - Number of Women Indicating Somewhat or Very Satisfied on a 5-point Likert Scale Measure of Intervention Satisfaction14 Participants
EducationAcceptability - Number of Women Indicating Somewhat or Very Satisfied on a 5-point Likert Scale Measure of Intervention Satisfaction19 Participants
p-value: 0.503Chi-squared
Primary

Feasibility - Number of Enrolled Women Participating in All Sessions

Number of enrolled women participating in all sessions

Time frame: 6 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
MindfulnessFeasibility - Number of Enrolled Women Participating in All Sessions15 Participants
EducationFeasibility - Number of Enrolled Women Participating in All Sessions22 Participants
p-value: 0.027Chi-squared
Secondary

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.

Time frame: Baseline and 12 weeks

ArmMeasureValue (MEAN)Dispersion
MindfulnessChange in FSFI Desire Score0.4 units on a scaleStandard Deviation 0.8
EducationChange in FSFI Desire Score0.7 units on a scaleStandard Deviation 0.7
Other Pre-specified

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.

Time frame: Baseline and 12 weeks

ArmMeasureValue (MEAN)Dispersion
MindfulnessChange in Overall Sexual Function4.0 units on a scaleStandard Deviation 5.1
EducationChange in Overall Sexual Function1.5 units on a scaleStandard Deviation 3
Other Pre-specified

Comprehensive Sexual Desire

Sexual Interest and Desire Inventory (SIDI)

Time frame: 6 weeks and 12 weeks

Other Pre-specified

Quality of Life - SF 36

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

Time frame: 6 weeks and 12 weeks

Other Pre-specified

Sexual Distress

Female Sexual Distress Scale - Revised (FSDS-R)

Time frame: 6 weeks and 12 weeks

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026