Hypoactive Sexual Desire DisorderNCT03232801
A Mindfulness-based Intervention for Older Women With Low Sexual Desire
A study testing mindfulness-based multicomponent intervention and general health education group in people with Hypoactive Sexual Desire Disorder and Sexual Dysfunction, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Hypoactive Sexual Desire Disorder, Sexual Dysfunction, Female Sexual Dysfunction
- What is being tested?
- mindfulness-based multicomponent intervention and general health education group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2020to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Being tested
- mindfulness-based multicomponent intervention, general health education group
- Keywords
- hypoactive sexual desire disorder, female sexual dysfunction, low libido, female sexual interest-arousal disorder, low desire, sexual dysfunction
- Medical subject headings
- Sexual Dysfunctions, Psychological, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based multicomponent interventionBehavioural
A group-based, multicomponent behavioral intervention rooted in mindfulness
general health education groupBehavioural
A general health and aging education group
| Study group | Role | What they receive |
|---|---|---|
| mindfulness group | Experimental | A multicomponent group-based intervention rooted in mindfulness, administered in 3 sessions over 6 weeks Receives: Behavioral: mindfulness-based multicomponent intervention |
| educational group | Active comparator | A general midlife health and aging educational group, administered in 3 sessions over 6 weeks Receives: Behavioral: general health education group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Number of Enrolled Women Participating in All Sessions
Number of enrolled women participating in all sessions
Measured: 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
Measured: 6 weeks
Secondary outcomes (1)
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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start8 Oct 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypoactive Sexual Desire DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Holly Thomas, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232801
- Sponsor's protocol ID
- PRO15060240
- Other IDs
- K23AG052628
- Status last verified
- Oct 2022
- First submitted
- 10 Mar 2017
- Last updated
- 13 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mindfulness-based Intervention for Older Women With Low Sexual Desire
- ClinicalTrials.gov ID
- NCT03232801
- Acronym / sponsor ID
- PRO15060240
- Keywords
- hypoactive sexual desire disorder, female sexual dysfunction, low libido, female sexual interest-arousal disorder, low desire, sexual dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Posted 13 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mindfulness group | Experimental | Behavioral: mindfulness-based multicomponent interventionA multicomponent group-based intervention rooted in mindfulness, administered in 3 sessions over 6 weeks |
| educational group | Active comparator | Behavioral: general health education groupA general midlife health and aging educational group, administered in 3 sessions over 6 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- active major depression
- active substance abuse
- current intimate partner violence
- partner with active major depression
- partner with active major substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness-based multicomponent interventionA group-based, multicomponent behavioral intervention rooted in mindfulness | Behavioural | mindfulness group |
| general health education groupA general health and aging education group | Behavioural | educational group |
Primary outcome
Feasibility - Number of Enrolled Women Participating in All Sessions
Time frame: 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
Time frame: 6 weeks
Number of women indicating "somewhat" or "very satisfied" on a 5-point Likert scale measure of intervention satisfaction
1 secondary outcome
Change in FSFI Desire Score
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness-based multicomponent intervention and general health education group in people with Hypoactive Sexual Desire Disorder and Sexual Dysfunction, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Number of Enrolled Women Participating in All Sessions (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.