NCT00175539

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2005

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2017

Enrollment Period

2.6 years

First QC Date

September 12, 2005

Last Update Submit

May 30, 2017

Conditions

Keywords

sexual dysfunctiongroup treatment

Outcome Measures

Primary Outcomes (1)

  • 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.

    following completion of data collection

Interventions

three 1.5 hour long group psychoeducational sessions

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UBC Sexual Health Lab, Vancouver Hospital

Vancouver, British Columbia, V5M 1M9, Canada

Location

BC Centre for Sexual Medicine

Vancouver, British Columbia, V5Z 1C6, Canada

Location

MeSH Terms

Conditions

Sexual Dysfunctions, PsychologicalSexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Mental DisordersGenital DiseasesUrogenital Diseases

Study Officials

  • Lori Brotto

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

November 1, 2005

Primary Completion

June 1, 2008

Study Completion

December 1, 2008

Last Updated

June 1, 2017

Record last verified: 2017-05

Locations