Female Sexual Dysfunction, Hypoactive Sexual Desire Disorder, Sexual Dysfunction
Conditions
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
A group-based, multicomponent behavioral intervention rooted in mindfulness
A general health and aging education group
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Number of Enrolled Women Participating in All Sessions | 6 weeks | 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 | 6 weeks | Number of women indicating somewhat or very satisfied on a 5-point Likert scale measure of intervention satisfaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in FSFI Desire Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Overall Sexual Function | 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. |
| Quality of Life - SF 36 | 6 weeks and 12 weeks | Quality of life as measured by Short Form-36 (SF-36) |
| Comprehensive Sexual Desire | 6 weeks and 12 weeks | Sexual Interest and Desire Inventory (SIDI) |
| Sexual Distress | 6 weeks and 12 weeks | Female 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
| Arm | Count |
|---|---|
| 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 |
| Total | 55 |
Baseline characteristics
| Characteristic | Education | Mindfulness | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 25 Participants | 49 Participants |
| Age, Continuous | 55.7 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 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 27 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 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 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 20 Participants | 44 Participants |
| Region of Enrollment United States | 27 participants | 28 participants | 55 participants |
| Sex: Female, Male Female | 27 Participants | 28 Participants | 55 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 30 |
| other Total, other adverse events | 0 / 31 | 0 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 30 |
Outcome results
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness | Acceptability - Number of Women Indicating Somewhat or Very Satisfied on a 5-point Likert Scale Measure of Intervention Satisfaction | 14 Participants |
| Education | Acceptability - Number of Women Indicating Somewhat or Very Satisfied on a 5-point Likert Scale Measure of Intervention Satisfaction | 19 Participants |
Feasibility - Number of Enrolled Women Participating in All Sessions
Number of enrolled women participating in all sessions
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness | Feasibility - Number of Enrolled Women Participating in All Sessions | 15 Participants |
| Education | Feasibility - Number of Enrolled Women Participating in All Sessions | 22 Participants |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness | Change in FSFI Desire Score | 0.4 units on a scale | Standard Deviation 0.8 |
| Education | Change in FSFI Desire Score | 0.7 units on a scale | Standard Deviation 0.7 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness | Change in Overall Sexual Function | 4.0 units on a scale | Standard Deviation 5.1 |
| Education | Change in Overall Sexual Function | 1.5 units on a scale | Standard Deviation 3 |
Comprehensive Sexual Desire
Sexual Interest and Desire Inventory (SIDI)
Time frame: 6 weeks and 12 weeks
Quality of Life - SF 36
Quality of life as measured by Short Form-36 (SF-36)
Time frame: 6 weeks and 12 weeks
Sexual Distress
Female Sexual Distress Scale - Revised (FSDS-R)
Time frame: 6 weeks and 12 weeks