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Group Psychoeducational Treatment for Women With Sexual Arousal Difficulties

Primary Purpose

Sexual Dysfunctions, Psychological

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
psychoeducational intervention
Sponsored by
University of British Columbia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Dysfunctions, Psychological focused on measuring sexual dysfunction, group treatment

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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. -

Sites / Locations

  • UBC Sexual Health Lab, Vancouver Hospital
  • BC Centre for Sexual Medicine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
May 30, 2017
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT00175539
Brief Title
Group Psychoeducational Treatment for Women With Sexual Arousal Difficulties
Official Title
Group Psychoeducational Treatment for Women With Sexual Arousal Difficulties
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunctions, Psychological
Keywords
sexual dysfunction, group treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
psychoeducational intervention
Intervention Description
three 1.5 hour long group psychoeducational sessions
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Brotto
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
UBC Sexual Health Lab, Vancouver Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5M 1M9
Country
Canada
Facility Name
BC Centre for Sexual Medicine
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1C6
Country
Canada

12. IPD Sharing Statement

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Group Psychoeducational Treatment for Women With Sexual Arousal Difficulties

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