A randomized clinical trial for women with vulvodynia: cognitive-behavioral therapy vs. supportive psychotherapy.

Masheb R. M., Kerns R. D., Lozano C. et al.  A randomized clinical trial for women with vulvodynia: cognitive-behavioral therapy vs. supportive psychotherapy.  Pain.  2009; 141: 31-40.

Appraiser: Stephanie Bush, DPT

1/11/12

Clinical Bottom Line:

Psychosocial treatments for vulvodynia are effective and well-tolerated, and CBT, a directed treatment approach that involves specific pain-relevant coping and self-management skills, yields better outcomes in pain severity, sexual function, and patient satisfaction compared to a less directed approach.

Clinical Question:

Is cognitive-behavioral therapy effective in conjunction with the physical therapy management of a 47 year old female with vulvodynia and dyspareunia with depressive symptoms?

Summary of Study Methods:

·         The purpose of this study was to perform a randomized trial to test the efficacy of cognitive-behavioral therapy and supportive psychotherapy in women with vulvodynia. 

·         The participants in the study were 50 women with vulvodynia who were enrolled at the Yale School of Medicine from September 2000 to December 2004. 

·         The mean age of the participants was 43, average duration of symptoms of 8.5 years, and 66% had a history of psychiatric co-morbidities including major depressive and anxiety disorders as most frequently reported. 

·         Participants with known or suspected vulvodynia who had been experiencing symptoms of vulvar or vaginal itching, stinging, or burning and/or painful intercourse for at least six months, were 21 years or older, and not pregnant. 

·         Participants underwent interview screenings including social history, psychiatric and medical histories, status of vulvar symptoms, evaluations by two gynecologists including medical history, pelvic examination and bimanual examination, and laboratory findings. 

·         Exclusion criteria included psychotic, suicidal, substance abuse, had a life-threatening illness, had started any treatment one month prior to assessment, and other gynecological diagnoses contributing to symptoms.  

·         The 50 women who met all eligible criteria were randomized to treatment groups from a computer generated randomization schedule. 

·         Study gynecologists performing follow-up examinations were blind to treatment assignment but the participants and research therapists were not. 

·         Study gynecologists obtained pain ratings for vulvar vestibulitis via the speculum rating based on pain provoked at the introitus, cotton-swab rating based on point tenderness provoked by palpation at six sites within the vulvar vestibule and erythema rating based on presence and degree of redness of skin. 

·         Pain measures completed by the participants included the McGill Pain Questionnaire and Female Sexual Function Index. 

·         Emotional function measures included The Beck Depression Inventory and The Pain Anxiety Symptoms Scale.

·          A global treatment improvement was measured with item, “Up to what point do you feel your vulvar pain has improved following the treatment you received in this study?” 

·         Treatments were for a duration of 10 weeks for 60-minute individual sessions by a doctoral level research therapist. 

·         The CBT group involved three phases: orientation to self-management approach, skills acquisition, and skills practice. 

o    Behavior skills included gate-control, activity pacing and goal setting. 

o   Gate-control skills identified and eliminated behaviors that increased vulvar pain and identified ones that reduced pain. 

o   Activity pacing involved limiting activities that increased pain. 

o   Goal setting indentified observable behaviors and setting weekly goals to attain a desired duration and frequency. 

o   Cognitive skills included indentifying triggers for negative mood states and thoughts, challenging the negative thought, and then restructuring the negative thought. 

o   Relaxation skills were taught in a progression starting with diaphragmatic breathing, progressive muscle relaxation, and relaxation specific to the pelvic floor muscles.  

·         The SPT group was a non-direct talk therapy following a patient-centered approach.  

o   The therapist’s role in this group was to have unconditional positive regard, to engage in emphatic understanding and to mirror the patient’s feelings.

o   These therapists were instructed to not make interpretations, problem-solve, challenge cognitions or initiate goal-setting.

Study Results:

·         Of the 50 participants, 88% completed CBT and 80% completed SPT, and treatment completers attended at least 80% of the 10 sessions. 

·         At the end of treatment, participants reported significantly less pain on physician’s measures of pain severity including cotton swab and speculum ratings and the MPI and MPQ pain questionnaires; significant improvement from pre- to post- treatment on the FSFI indicating improved sexual function; significantly lower scores on the PASS and BDI indicating improved emotional function. 

·         CBT group compared to SPT demonstrated a more decline in pain severity on cotton swab palpation, greater improvement in FSFI, and self-reports in significantly better sexual function at the end of treatment.

·         Overall reduction on pain severity by 35.8% as measured by the MPI and 37.7% as measured by the MPQ (33% reduction has been shown to be clinically meaningful). 

·         Maintenance outcomes from post-treatment to 3 months, 6 months and one year follow-ups were performed. 

·         There was significant improvements in the pain severity subscale of the MPI and pain anxiety as measured by the PASS during the follow-up period. 

·         Participants in the CBT group reported significantly greater global improvement, treatment satisfaction, and viewed treatment as more credible compared to the SPT group. 

Discussion/Comments:

·         Participants in both treatment groups significantly improved all outcome measures including pain severity, sexual function and emotional function. 

·         The CBT group had greater improvements in pain severity on the cotton swab palpation test and overall sexual function and greater global treatment satisfaction compared to the SPT group. 

·         Outcome measures from post-treatment to one year followed remained the same or improved for self-report pain severity and pain anxiety measures. 

·         Limitations included the use of vaginal dilators was not used which is a common treatment for vaginismus and the study’s findings may not generalize to other behavioral, medical or nutritional treatments that have been used to treat vulvodynia. 

·         The results of this study indicate the psychosocial treatments are beneficial in treating patients with vulvodynia. 

·         CBT, in particular, is effective, well-tolerated, and demonstrates significant improvements in pain severity and patient satisfaction for those diagnosed with vulvodynia. 

·         Within physical therapy clinical practice, the measures of pain on cotton-swab palpation and FSFI are outcome measures that can be used within the clinic to monitor patient improvements and satisfaction with treatment.