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| ID | Type | Description | Link |
|---|---|---|---|
| K23AG052628 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mindfulness group | Experimental | A multicomponent group-based intervention rooted in mindfulness, administered in 3 sessions over 6 weeks |
|
| educational group | Active Comparator | A general midlife health and aging educational group, administered in 3 sessions over 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mindfulness-based multicomponent intervention | Behavioral | A group-based, multicomponent behavioral intervention rooted in mindfulness |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 weeks |
| Comprehensive Sexual Desire |
Inclusion Criteria:
Exclusion Criteria:
women participants only
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
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81 women were screened. 19 women were ineligible (N=62 enrolled). One woman withdrew after consent but before randomization. N=61 women were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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61 participants were randomized, but only 55 participants completed baseline assessments
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility - Number of Enrolled Women Participating in All Sessions | Number of enrolled women participating in all sessions | Posted | Count of Participants | Participants | 6 weeks |
|
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Holly Thomas | University of Pittsburgh | 412-586-9836 | thomashn@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 1, 2022 | Aug 1, 2022 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 1, 2022 | Aug 1, 2022 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| general health education group | Behavioral | A general health and aging education group |
|
Sexual Interest and Desire Inventory (SIDI)
| 6 weeks and 12 weeks |
| Sexual Distress | Female Sexual Distress Scale - Revised (FSDS-R) | 6 weeks and 12 weeks |
| Quality of Life - SF 36 | Quality of life as measured by Short Form-36 (SF-36) | 6 weeks and 12 weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Female Sexual Function Index (FSFI) | The Female Sexual Function Index (FSFI) is a 19-item self-report inventory designed to assess female sexual function. It comprises six domains: desire [two items], arousal [four items], lubrication [four items], orgasm, satisfaction, pain [three items each]. The FSFI total score is the sum of the 6 domain/subscale scores. The minimum score is 2.0. The maximum score is 36.0. Higher scores indicate worse functioning. A total score 26.0 has been validated as a cutoff score for diagnosing Female Sexual Dysfunction. | Mean | Standard Deviation | units on a scale |
|
| Female Sexual Distress Scale - Revised (FSDS-R) | The Female Sexual Distress Scale-Revised (FSDS-R) was created and validated to assess distress associated with impaired sexual function. It contains 13 items. The total score, ranging from 0 to 48, provides a measure of sexual distress, in which the higher the score, the higher the level of sexual distress. | Mean | Standard Deviation | units on a scale |
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| 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 | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
|
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| Other Pre-specified | Comprehensive Sexual Desire | Sexual Interest and Desire Inventory (SIDI) | Not Posted | 6 weeks and 12 weeks | Participants |
| Other Pre-specified | Sexual Distress | Female Sexual Distress Scale - Revised (FSDS-R) | Not Posted | 6 weeks and 12 weeks | Participants |
| Other Pre-specified | Quality of Life - SF 36 | Quality of life as measured by Short Form-36 (SF-36) | Not Posted | 6 weeks and 12 weeks | Participants |
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | 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 | 0 | 30 | 0 | 30 | 0 | 30 |
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