Group Psychoeducational Treatment for Women With Sexual Arousal Difficulties, Phase II

Low Female Sexual Desire Clinical Trial

— Group PED  

Official title:

Group Psychoeducational Treatment for Women With Sexual Arousal Difficulties, Phase II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01706406
• Other study ID #: C05-0400-II
• Status: Completed
• Phase: N/A
• First received: October 29, 2010
• Last updated: May 30, 2017
• Start date: November 2007
• Est. completion date: June 2012

Study information

• Verified date: May 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to pilot test and determine the efficacy of a psychoeducational intervention (PED) we recently piloted 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.

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, and for healthy women with FSAD. 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 determine the efficacy of the group PED for currently seeking treatment at the BC Centre for Sexual Medicine for FSAD. By using a waitlist control group, we can determine if any improvement in sexual function is due to treatment or the passage of time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• between the ages of 19 and 65

• currently seeking treatment at the BC Centre for Sexual Medicine

• meet clinical criteria for acquired Female Sexual Arousal Disorder (FSAD);

• be proficient in English and willing to take part in group sessions.

Exclusion Criteria:

• does not meet clinical criteria for acquired Female Sexual Arousal Disorder (FSAD)

• not currently Seeking seeking treatment at the BC Centre for Sexual Medicine

Related Conditions & MeSH terms

• Low Female Sexual Arousal
• Low Female Sexual Desire

Intervention

Behavioral:
• Brief psychoeducational intervention for female sexual arousal disorder
four 1.5 hour long group psychoeducational sessions, spaced 2 weeks apart for a total of 8 weeks.

Locations

Country	Name	City	State
Canada	UBC Sexual Health Lab, Vancouver Hospital	Vancouver	British Columbia
Canada	BC Centre for Sexual Medicine	Vancouver,	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sexual Distress	Sexual distress will be measured with the Female Sexual Distress Scale (FSDS, Derogatis et al. 2002). The FSDS is a 12-item self-report questionnaire assessing for sexuality related personal distress.	Sexual distress will be assessed approximately one week pre-treatment, approximatley two weeks post-treatment and approximately 6-months post-treatment
Other	Mood	Mood will be measured with the Beck Depression Inventory (BDI; Beck & Beamesderfer, 1974), a widely-used self-report questionnaire designed to assess the severity of depressive symptoms.	Mood will be assessed approximately one week pre-treatment, approximatley two weeks post-treatment and approximately 6-months post-treatment
Primary	Change in physiological sexual arousal	Sexual arousal will be measured physiologically with a Vaginal Photoplethysmograph (VPP). The VPP measures vaginal pulse amplitude (VPA) which has been found to be a sensitive and specific measure of genital arousal (Laan & Everaerd, 1995).	Sexual arousal will be measured approximately one week pre-treatment and approxiately two weeks post-treatment
Primary	Long-term change in physiological sexual arousal	Sexual arousal will be measured physiologically with a Vaginal Photoplethysmograph (VPP). The VPP measures vaginal pulse amplitude (VPA) which has been found to be a sensitive and specific measure of genital arousal (Laan & Everaerd, 1995).	Sexual arousal will be assessed approximately one-week pre-treatment and approximately 6 months post treatment
Secondary	Subjective sexual arousal	The Female Sexual Function Inventory (FSFI; Rosen et al. 2000) questionnaire will be used to measure subjective sexual arousal. The FSFI a 19-item self-report questionnaire which assesses sexual function in women. It covers six sexual domains: lubrication, arousal, desire, pain, orgasm and satisfaction.	Subjective sexual arousal will be assessed approximately one week pre-treatment, approximately two-weeks post-treatment and approximately 6-months post treatment