An interventional study of Brief psychoeducational intervention for female sexual arousal disorder in Low Female Sexual Arousal and Low Female Sexual Desire, sponsored by University of British Columbia. Completed at 2 sites in Canada. Open to female participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-06-01.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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:
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.
University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
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Exclusion Criteria:
Women randomized into the "treatment" group will undergo pre-treatment testing (questionnaires and physiological assessment)within 14 days of beginning treatment
Behavioral: Brief psychoeducational intervention for female sexual arousal disorder
Women randomized to the "waitlist" group will undergo initial testing (questionnaires and physiological testing) and receive no treatment until the next scheduled group (4 months). They will undergo pretreatment testing and treatment on the same schedule as women in the "treatment" group.
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.
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).
Time frame: Sexual arousal will be measured approximately one week pre-treatment and approxiately two weeks post-treatment
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).
Time frame: Sexual arousal will be assessed approximately one-week pre-treatment and approximately 6 months post treatment
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.
Time frame: Subjective sexual arousal will be assessed approximately one week pre-treatment, approximately two-weeks post-treatment and approximately 6-months post treatment
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.
Time frame: Sexual distress will be assessed approximately one week pre-treatment, approximatley two weeks post-treatment and approximately 6-months post-treatment
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.
Time frame: Mood will be assessed approximately one week pre-treatment, approximatley two weeks post-treatment and approximately 6-months post-treatment
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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University of British Columbia