Low Female Sexual ArousalGroup PEDNCT01706406
Group Psychoeducational Treatment for Women With Sexual Arousal Difficulties, Phase II
A study testing Brief psychoeducational intervention for female sexual arousal disorder in people with Low Female Sexual Arousal and Low Female Sexual Desire, run by University of British Columbia at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women only
- Conditions the study is for
- Low Female Sexual Arousal, Low Female Sexual Desire
- What is being tested?
- Brief psychoeducational intervention for female sexual arousal disorder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2007to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- does not meet clinical criteria for acquired Female Sexual Arousal Disorder (FSAD)
- not currently Seeking seeking treatment at the BC Centre for Sexual Medicine
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
BC Centre for Sexual Medicine
Vancouver, British Columbia, V5Z 1C6
UBC Sexual Health Lab, Vancouver Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
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:
- - 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.
- - It is unknown what effect the PED will have on actual physiological sexual arousal.
- - 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.
Read the detailed 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.
- Being tested
- Brief psychoeducational intervention for female sexual arousal disorder
- Keywords
- female sexual arousal, female sexual desire, psychoeducational intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief psychoeducational intervention for female sexual arousal disorderBehavioural
four 1.5 hour long group psychoeducational sessions, spaced 2 weeks apart for a total of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 treatment | Experimental | Women randomized into the "treatment" group will undergo pre-treatment testing (questionnaires and physiological assessment)within 14 days of beginning treatment Receives: 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. Receives: Behavioral: Brief psychoeducational intervention for female sexual arousal disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Sexual arousal will be assessed approximately one-week pre-treatment and approximately 6 months post treatment
Secondary outcomes (1)
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.
Measured: Subjective sexual arousal will be assessed approximately one week pre-treatment, approximately two-weeks post-treatment and approximately 6-months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startNov 2007
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Female Sexual ArousalStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Brotto, University of British Columbia
- Investigators
- Lori A Brotto, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706406
- Sponsor's protocol ID
- C05-0400-II
- Acronym
- Group PED
- Status last verified
- May 2017
- First submitted
- 29 Oct 2010
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Psychoeducational Treatment for Women With Sexual Arousal Difficulties, Phase II
- ClinicalTrials.gov ID
- NCT01706406
- Acronym / sponsor ID
- Group PED / C05-0400-II
- Keywords
- female sexual arousal, female sexual desire, psychoeducational intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- - 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.
- - It is unknown what effect the PED will have on actual physiological sexual arousal.
- - 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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 treatment | Experimental | Behavioral: Brief psychoeducational intervention for female sexual arousal disorderWomen randomized into the "treatment" group will undergo pre-treatment testing (questionnaires and physiological assessment)within 14 days of beginning treatment |
| 2 waitlist | Other | Behavioral: Brief psychoeducational intervention for female sexual arousal disorderWomen 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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- does not meet clinical criteria for acquired Female Sexual Arousal Disorder (FSAD)
- not currently Seeking seeking treatment at the BC Centre for Sexual Medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief psychoeducational intervention for female sexual arousal disorderfour 1.5 hour long group psychoeducational sessions, spaced 2 weeks apart for a total of 8 weeks. | Behavioural | 1 treatment, 2 waitlist |
Primary outcome
Change in physiological sexual arousal
Time frame: Sexual arousal will be measured approximately one week pre-treatment and approxiately two weeks post-treatment
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).
Long-term change in physiological sexual arousal
Time frame: Sexual arousal will be assessed approximately one-week pre-treatment and approximately 6 months post treatment
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).
1 secondary outcome
Subjective sexual arousal
Time frame: Subjective sexual arousal will be assessed approximately one week pre-treatment, approximately two-weeks post-treatment and approximately 6-months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- UBC Sexual Health Lab websiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori A Brotto, PhD principal investigator
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief psychoeducational intervention for female sexual arousal disorder in people with Low Female Sexual Arousal and Low Female Sexual Desire, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physiological sexual arousal (time frame: Sexual arousal will be measured approximately one week pre-treatment and approxiately two weeks post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.