- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00175539
Group Psychoeducational Treatment for Women With Sexual Arousal Difficulties
The purpose of this study is to pilot test and determine the feasibility of a psychoeducational intervention (PED) we recently developed in a group format for women with acquired sexual arousal disorder (FSAD).
HYPOTHESES:
- 1 - Compared to baseline measures, the PED will result in significant improvement in self-report measures of: (a) subjective sexual arousal; (b) perception of genital arousal/genital sensitivity; (c) orgasmic experience; (d) sexual desire; (e) sexual distress; (f) relationship satisfaction; (g) depressive symptoms; and (h) quality of life.
- 2 - It is unknown what effect the PED will have on actual physiological sexual arousal.
- 3 - The group format will be a feasible and cost-effective method of delivering empirically supported treatment to women with sexual arousal difficulties and will contribute towards meeting the needs for sexual health care for women on the clinic wait-list at the BC Centre for Sexual Medicine.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sexual arousal difficulties are common among women, affecting approximately 22% of women between the ages of 18 and 59 (Laumann, Paik & Rosen, 1999). Although there are evidence-based psychological treatments available for women with orgasmic and pain disorders, there are currently no empirically-supported treatments for women with acquired Sexual Arousal Disorder (FSAD). Moreover, there have been numerous attempts to find evidence for a pharmacological agent effective at treating women's sexual arousal complaints; however, to date these studies have been inconclusive. Given the significant role that sexual health plays in quality of life, the fact that effective psychological treatments for women's sexual dysfunction are not widely available, and the fact that wait-lists to see health care professionals with expertise in the area of sexual dysfunction are often unwieldy, there is a need to establish brief, evidence-based approaches to treat women's acquired FSAD. Psychological therapy in a group format is a standard practice at the BC Centre for Sexual Medicine. However, in this study we would like to collect information from participants that would help us in determining the specific efficacy of the PED as well as identifying demographic or participant variables that might predict a positive response to the PED. Because we are using this information to determine the treatment's efficacy and because we will use this information as the basis for a publication, we deem this to be a research trial in which ethics review is necessary.
OBJECTIVES: We have recently developed and tested a new psychoeducational treatment (PED) for the treatment of FSAD due to early-stage gynecologic cancer treatment. Our data show this PED to significantly improve self-reported sexual desire, arousal, mood, relationship distress, and quality of life. We are currently testing the efficacy of this PED in a larger sample of cancer survivors with FSAD. The goal for this study is to test our PED in a group format for women who are currently seeking treatment at the BC Centre for Sexual Medicine for FSAD. By testing the efficacy of the PED administered in a group format, we hope to establish some preliminary data supporting the use of brief psychoeducational interventions for women. These pilot data will be used in a future larger-scale trial that involves randomization to group PED or a control condition in order to more definitively establish the PED efficacy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5M 1M9
- UBC Sexual Health Lab, Vancouver Hospital
-
Vancouver, British Columbia, Canada, V5Z 1C6
- BC Centre for Sexual Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women between the ages of 19 and 65 who are currently seeking treatment at the BC Centre for Sexual Medicine;
- Women who are determined to meet criteria for acquired Female Sexual Arousal Disorder (FSAD);
- Must be proficient in English and willing to take part in group sessions.
Exclusion Criteria:
Women who do not meet criteria for FSAD, as determined by the Co-Investigators, will not be informed about the study. In addition, women who might not be suitable for group therapy will be excluded.
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Upon completion of data analysis, establishment of the efficacy of Psychoeducational intervention (PED) in group format for the treatment women with Female Sexual Arousal Disorder will be determined.
Time Frame: following completion of data collection
|
following completion of data collection
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lori Brotto, University of British Columbia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C05-0400
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sexual Dysfunctions, Psychological
-
University of LuxembourgLinkoeping University; University of Lausanne; Luxembourg National Research Fund...CompletedSexual Dysfunction | Sexual Dysfunctions, PsychologicalLuxembourg
-
Lidia LarrañagaUnknownSexual Dysfunctions, Psychological
-
Sprout Pharmaceuticals, IncCompletedSexual Dysfunctions, PsychologicalUnited States
-
Sprout Pharmaceuticals, IncCompletedSexual Dysfunctions, PsychologicalUnited States, Canada
-
Daré Bioscience, Inc.Strategic Science & Technologies, LLCRecruiting
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedSexual Dysfunctions, Psychological | Sexual Arousal DisorderUnited States
-
Strategic Science & Technologies, LLCCompletedSexual Arousal DisorderUnited States
-
Palatin Technologies, IncKing Pharmaceuticals is now a wholly owned subsidiary of PfizerCompletedSexual Arousal DisorderUnited States
-
QualiLife PharmaceuticalsCompleted
-
Sprout Pharmaceuticals, IncTerminatedDepression | Sexual Dysfunctions, PsychologicalUnited States
Clinical Trials on psychoeducational intervention
-
Universidad de MonterreyFEMSA Foundation; Mexican Food BanksCompletedMalnutrition | Malnutrition, Child | Malnutrition in Children | Child Malnutrition | Child Overnutrition | Nutrition Disorders, ChildMexico
-
Emory UniversityNational Institute on Aging (NIA)Completed
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR)Completed
-
M.D. Anderson Cancer CenterRecruitingFatigue | Metastatic CancersUnited States
-
Copenhagen University Hospital, HvidovreRecruitingCOVID-19 | Anxiety | Mental Health | PsychoeducationDenmark
-
Rosa JimenezTerminatedSexually Transmitted Diseases, Viral | Sexually Transmitted Diseases | Sexually Transmitted Diseases, BacterialChile
-
University of New MexicoHyundai Hope On WheelsWithdrawn
-
Zhengzhou UniversityNot yet recruitingCongenital Heart DefectChina
-
Universidade do PortoFundação para a Ciência e a Tecnologia; Centro de Investigação em Tecnologias... and other collaboratorsCompletedCongenital Heart DefectsPortugal
-
Consorci Hospitalari de VicGovernment of CataloniaCompleted