Trial Outcomes & Findings for A Mindfulness-based Intervention for Older Women With Low Sexual Desire (NCT NCT03232801)
NCT ID: NCT03232801
Last Updated: 2022-10-13
Results Overview
Number of enrolled women participating in all sessions
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
6 weeks
Results posted on
2022-10-13
Participant Flow
81 women were screened. 19 women were ineligible (N=62 enrolled). One woman withdrew after consent but before randomization. N=61 women were randomized.
Participant milestones
| Measure |
Mindfulness Group
A multicomponent group-based intervention rooted in mindfulness, administered in 3 sessions over 6 weeks
mindfulness-based multicomponent intervention: A group-based, multicomponent behavioral intervention rooted in mindfulness
|
Educational Group
A general midlife health and aging educational group, administered in 3 sessions over 6 weeks
general health education group: A general health and aging education group
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
|
Overall Study
Completed Baseline Survey
|
28
|
27
|
|
Overall Study
Attended at Least One Session
|
18
|
23
|
|
Overall Study
Completed Week 7 Follow-up
|
15
|
22
|
|
Overall Study
Completed Week 12 Follow-up
|
15
|
18
|
|
Overall Study
COMPLETED
|
15
|
18
|
|
Overall Study
NOT COMPLETED
|
16
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Mindfulness-based Intervention for Older Women With Low Sexual Desire
Baseline characteristics by cohort
| Measure |
Mindfulness
n=28 Participants
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.
|
Education
n=27 Participants
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.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
55.8 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
27 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Female Sexual Function Index (FSFI)
|
21.1 units on a scale
STANDARD_DEVIATION 6.1 • n=5 Participants
|
20.5 units on a scale
STANDARD_DEVIATION 7.3 • n=7 Participants
|
20.7 units on a scale
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Female Sexual Distress Scale - Revised (FSDS-R)
|
23.3 units on a scale
STANDARD_DEVIATION 11.9 • n=5 Participants
|
18.5 units on a scale
STANDARD_DEVIATION 8.8 • n=7 Participants
|
20.7 units on a scale
STANDARD_DEVIATION 10.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksNumber of enrolled women participating in all sessions
Outcome measures
| Measure |
Mindfulness
n=31 Participants
Assigned to mindfulness-based intervention group
|
Education
n=30 Participants
Assigned to general menopause education group
|
|---|---|---|
|
Feasibility - Number of Enrolled Women Participating in All Sessions
|
15 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: 6 weeksNumber of women indicating "somewhat" or "very satisfied" on a 5-point Likert scale measure of intervention satisfaction
Outcome measures
| Measure |
Mindfulness
n=15 Participants
Assigned to mindfulness-based intervention group
|
Education
n=22 Participants
Assigned to general menopause education group
|
|---|---|---|
|
Acceptability - Number of Women Indicating "Somewhat" or "Very Satisfied" on a 5-point Likert Scale Measure of Intervention Satisfaction
|
14 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Baseline 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.
Outcome measures
| Measure |
Mindfulness
n=15 Participants
Assigned to mindfulness-based intervention group
|
Education
n=18 Participants
Assigned to general menopause education group
|
|---|---|---|
|
Change in FSFI Desire Score
|
0.4 units on a scale
Standard Deviation 0.8
|
0.7 units on a scale
Standard Deviation 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline 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.
Outcome measures
| Measure |
Mindfulness
n=15 Participants
Assigned to mindfulness-based intervention group
|
Education
n=18 Participants
Assigned to general menopause education group
|
|---|---|---|
|
Change in Overall Sexual Function
|
4.0 units on a scale
Standard Deviation 5.1
|
1.5 units on a scale
Standard Deviation 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeks and 12 weeksSexual Interest and Desire Inventory (SIDI)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeks and 12 weeksFemale Sexual Distress Scale - Revised (FSDS-R)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeks and 12 weeksQuality of life as measured by Short Form-36 (SF-36)
Outcome measures
Outcome data not reported
Adverse Events
Mindfulness Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Educational Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place