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

NCT ID: NCT03232801

Last Updated: 2022-10-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-08

Study Completion Date

2021-09-01

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.

Conditions

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Hypoactive Sexual Desire Disorder Sexual Dysfunction Female Sexual Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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mindfulness group

A multicomponent group-based intervention rooted in mindfulness, administered in 3 sessions over 6 weeks

Group Type EXPERIMENTAL

mindfulness-based multicomponent intervention

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

general health education group

Intervention Type BEHAVIORAL

A general health and aging education group

Interventions

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mindfulness-based multicomponent intervention

A group-based, multicomponent behavioral intervention rooted in mindfulness

Intervention Type BEHAVIORAL

general health education group

A general health and aging education group

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Holly Thomas

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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K23AG052628

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO15060240

Identifier Type: -

Identifier Source: org_study_id

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