NCT01706406

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. 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. 2.\- It is unknown what effect the PED will have on actual physiological sexual arousal.
  3. 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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 15, 2012

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2017

Enrollment Period

4.6 years

First QC Date

October 29, 2010

Last Update Submit

May 30, 2017

Conditions

Keywords

female sexual arousalfemale sexual desirepsychoeducational intervention

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

EXPERIMENTAL

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

2 waitlist

OTHER

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

Interventions

four 1.5 hour long group psychoeducational sessions, spaced 2 weeks apart for a total of 8 weeks.

1 treatment2 waitlist

Eligibility Criteria

Age19 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

UBC Sexual Health Lab, Vancouver Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Links

Study Officials

  • Lori A Brotto, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

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

Locations