Group Psychoeducational Treatment for Women With Sexual Arousal Difficulties, Phase II
Group PED
1 other identifier
interventional
98
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2007
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Posted
Study publicly available on registry
October 15, 2012
CompletedJune 1, 2017
May 1, 2017
4.6 years
October 29, 2010
May 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
Subjective sexual arousal
Subjective sexual arousal will be assessed approximately one week pre-treatment, approximately two-weeks post-treatment and approximately 6-months post treatment
Other Outcomes (2)
Sexual Distress
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 assessed approximately one week pre-treatment, approximatley two weeks post-treatment and approximately 6-months post-treatment
Study Arms (2)
1 treatment
EXPERIMENTALWomen randomized into the "treatment" group will undergo pre-treatment testing (questionnaires and physiological assessment)within 14 days of beginning treatment
2 waitlist
OTHERWomen 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.
Interventions
four 1.5 hour long group psychoeducational sessions, spaced 2 weeks apart for a total of 8 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- does not meet clinical criteria for acquired Female Sexual Arousal Disorder (FSAD)
- not currently Seeking seeking treatment at the BC Centre for Sexual Medicine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
BC Centre for Sexual Medicine
Vancouver, British Columbia, V5Z 1C6, Canada
UBC Sexual Health Lab, Vancouver Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Lori A Brotto, PhD
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 29, 2010
First Posted
October 15, 2012
Study Start
November 1, 2007
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
June 1, 2017
Record last verified: 2017-05