Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175539
Status:
COMPLETED
Last Update Posted:
2017-06-01
First Post:
2005-09-12
Brief Title:
Group Psychoeducational Treatment for Women With Sexual Arousal Difficulties
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Group Psychoeducational Treatment for Women With Sexual Arousal Difficulties
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 arousalgenital 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
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 arousalgenital 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
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 womens 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 womens 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 womens 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 treatments 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None