VulvodyniaNCT00607490
A Randomized Clinical Trial for Women With Vulvodynia
A study testing Cognitive-Behavioral Therapy and Supportive Psychotherapy in people with Vulvodynia, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Trial summary
This study will evaluate the relative effectiveness of cognitive-behavioral therapy and supportive psychotherapy for the treatment of women with vulvodynia. Read more about this study
- Who is it for?
- Ages 21 to 60 years, women only
- Conditions the study is for
- Vulvodynia
- What is being tested?
- Cognitive-Behavioral Therapy and Supportive Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2000to Mar 2005
- 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 21 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Independently diagnosed with vulvodynia by two study physicians
Who cannot join
- Any conditions known to better account for the vulvar pain
- Psychotic illness
- Actively suicidal
- Substance dependent
- Life-threatening illness
- Initiated psychotherapy, psychopharmacologic treatment or pain medication within one month prior to beginning the assessment phase of the study.
About this study
Official title: Cognitive-behavioral Therapy for Vulvodynia: a Clinical Trial
This study will evaluate the relative effectiveness of cognitive-behavioral therapy and supportive psychotherapy for the treatment of women with vulvodynia.
Read the detailed description
Many treatments used for women with vulvodynia are based solely upon expert opinion. This randomized trial aimed to test the relative efficacy of cognitive-behavioral therapy (CBT) and supportive psychotherapy (SPT) in women with vulvodynia. Of the 50 participants, 42 (84%) completed 10-week treatments and 47 (94%) completed one-year follow-up. Mixed effects modeling was used to make use of all available data. Participants had statistically significant decreases in pain severity (p's<.001) with 42% of the overall sample achieving clinical improvement. CBT, relative to SPT, resulted in significantly greater improvement in pain severity during physician examination (p=.014), and greater improvement in sexual function (p=.034), from pre- to post-treatment. Treatment effects were well maintained at one-year follow-up in both groups. Participants in the CBT condition reported significantly greater treatment improvement, satisfaction and credibility than participants in the SPT condition (p's<.05). Findings from the present study suggest that psychosocial treatments for vulvodynia are effective. CBT, a directed treatment approach that involves learning and practice of specific pain-relevant coping and self-management skills, yielded better outcomes and greater patient satisfaction than a less directive approach.
- Conditions
- Vulvodynia
- Being tested
- Cognitive-Behavioral Therapy, Supportive Psychotherapy
- Keywords
- Vulvodynia, Vulvar pain, Dyspareunia, Sexual dysfunction, Vestibulitis
- Medical subject headings
- Vulvodynia, Dyspareunia, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral TherapyBehavioural
Behavioral, cognitive, sex therapy and relaxation interventions administered to teach self-management skills for pain control.
Supportive PsychotherapyBehavioural
Patient-centered talk therapy to assist participants in expressing their thoughts and feelings.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-behavioral Therapy | Experimental | 10 weekly individual 60-minute sessions Receives: Behavioral: Cognitive-Behavioral Therapy |
| Supportive Psychotherapy | Active comparator | 10 weekly individual 60-minute sessions Receives: Behavioral: Supportive Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity
Measured: Measured at 1-year follow-up
Secondary outcomes (2)
Sexual Functioning
Measured: Measured at 1-year follow-up
Emotional Functioning
Measured: Measured at 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startSep 2000
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Robin M Masheb, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607490
- Sponsor's protocol ID
- R01HD038493
- Status last verified
- Jan 2008
- First submitted
- 22 Jan 2008
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-behavioral Therapy for Vulvodynia: a Clinical Trial
- ClinicalTrials.gov ID
- NCT00607490
- Acronym / sponsor ID
- R01HD038493
- Conditions
- Vulvodynia
- Keywords
- Vulvodynia, Vulvar pain, Dyspareunia, Sexual dysfunction, Vestibulitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Sep 2000
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 5 Feb 2008 (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.
This study will evaluate the relative effectiveness of cognitive-behavioral therapy and supportive psychotherapy for the treatment of women with vulvodynia.
Detailed description
Many treatments used for women with vulvodynia are based solely upon expert opinion. This randomized trial aimed to test the relative efficacy of cognitive-behavioral therapy (CBT) and supportive psychotherapy (SPT) in women with vulvodynia. Of the 50 participants, 42 (84%) completed 10-week treatments and 47 (94%) completed one-year follow-up. Mixed effects modeling was used to make use of all available data. Participants had statistically significant decreases in pain severity (p's<.001) with 42% of the overall sample achieving clinical improvement. CBT, relative to SPT, resulted in significantly greater improvement in pain severity during physician examination (p=.014), and greater improvement in sexual function (p=.034), from pre- to post-treatment. Treatment effects were well maintained at one-year follow-up in both groups. Participants in the CBT condition reported significantly greater treatment improvement, satisfaction and credibility than participants in the SPT condition (p's<.05). Findings from the present study suggest that psychosocial treatments for vulvodynia are effective. CBT, a directed treatment approach that involves learning and practice of specific pain-relevant coping and self-management skills, yielded better outcomes and greater patient satisfaction than a less directive approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavioral Therapy | Experimental | Behavioral: Cognitive-Behavioral Therapy10 weekly individual 60-minute sessions |
| Supportive Psychotherapy | Active comparator | Behavioral: Supportive Psychotherapy10 weekly individual 60-minute sessions |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Independently diagnosed with vulvodynia by two study physicians
Key exclusion criteria (6 listed)
- Any conditions known to better account for the vulvar pain
- Psychotic illness
- Actively suicidal
- Substance dependent
- Life-threatening illness
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 |
|---|---|---|
| Cognitive-Behavioral TherapyBehavioral, cognitive, sex therapy and relaxation interventions administered to teach self-management skills for pain control. | Behavioural | Cognitive-behavioral Therapy |
| Supportive PsychotherapyPatient-centered talk therapy to assist participants in expressing their thoughts and feelings. | Behavioural | Supportive Psychotherapy |
Primary outcome
Pain Severity
Time frame: Measured at 1-year follow-up
2 secondary outcomes
Sexual Functioning
Time frame: Measured at 1-year follow-up
Emotional Functioning
Time frame: Measured at 1-year follow-up
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 23 May 2016.
Related trials for Vulvodynia
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
Vulvodynia
Not yet recruiting
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Vestibulodynia, Vulvodynia
Active, not recruiting
Vestibulectomy Surgical Techniques Comparison Study
Vulvar Pain, Vulvodynia
Not yet recruiting
Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
Refractory Visceral Pelvic Pain, Refractory Genital Pain
Not yet recruitingPhase 2
A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia
Vulvodynia
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.
Robin M Masheb, Ph.D. principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Therapy and Supportive Psychotherapy in people with Vulvodynia, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
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 1 inclusion and 6 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 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain Severity (time frame: Measured at 1-year follow-up). 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 23 May 2016.