ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 37 for:    Sexual | Recruiting, Not yet recruiting, Available Studies | "sexual dysfunction" women

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03232801
Recruitment Status : Not yet recruiting
First Posted : July 28, 2017
Last Update Posted : July 31, 2018
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Holly Thomas, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Hypoactive Sexual Desire Disorder Sexual Dysfunction Female Sexual Dysfunction Behavioral: mindfulness-based multicomponent intervention Behavioral: general health education group Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: A Mindfulness-based Intervention for Older Women With Low Sexual Desire
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: mindfulness group
a multicomponent group-based intervention rooted in mindfulness, administered in 3 sessions over 6 weeks
Behavioral: mindfulness-based multicomponent intervention
A group-based, multicomponent behavioral intervention rooted in mindfulness

Active Comparator: educational group
a general midlife health and aging educational group, administered in 3 sessions over 6 weeks
Behavioral: general health education group
A general health and aging education group




Primary Outcome Measures :
  1. Feasibility: Proportion of enrolled women participating in all sessions [ Time Frame: 6 weeks ]
  2. Acceptability: Proportion of women indicating "somewhat" or "very satisfied" on a 5-point Likert scale measure of intervention satisfaction [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Desire [ Time Frame: 6 weeks and 12 weeks ]
    Change in Female Sexual Function Index (FSFI) desire score


Other Outcome Measures:
  1. Overall sexual function [ Time Frame: 6 weeks and 12 weeks ]
    Total FSFI score

  2. Comprehensive sexual desire [ Time Frame: 6 weeks and 12 weeks ]
    Sexual Interest and Desire Inventory (SIDI)

  3. Sexual distress [ Time Frame: 6 weeks and 12 weeks ]
    Female Sexual Distress Scale - Revised (FSDS-R)

  4. Quality of life [ Time Frame: 6 weeks and 12 weeks ]
    Short Form-36 (SF-36)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women participants only
Accepts Healthy Volunteers:   No
Criteria

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)

Responsible Party: Holly Thomas, Assistant Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03232801     History of Changes
Other Study ID Numbers: PRO15060240
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Holly Thomas, University of Pittsburgh:
hypoactive sexual desire disorder
female sexual dysfunction
low libido
female sexual interest-arousal disorder
low desire
sexual dysfunction

Additional relevant MeSH terms:
Hypokinesia
Sexual Dysfunctions, Psychological
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders