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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hypoactive Sexual Desire Disorder, Sexual Dysfunction, Female Sexual Dysfunction

Intervention / Treatment
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* Behavioral: mindfulness-based multicomponent intervention
* Behavioral: general health education group


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mindfulness group<br>A multicomponent group-based intervention rooted in mindfulness, administered in 3 sessions over 6 weeks | Behavioral: mindfulness-based multicomponent intervention<br>* A group-based, multicomponent behavioral intervention rooted in mindfulness<br>|
| Active Comparator: educational group<br>A general midlife health and aging educational group, administered in 3 sessions over 6 weeks | Behavioral: general health education group<br>* A general health and aging education group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypoactive sexual desire disorder, female sexual dysfunction, low libido, female sexual interest-arousal disorder, low desire, sexual dysfunction