Efficacy of Cognitive Behavior Therapy for Treatment of Chronic Pelvic Pain in Women
June 20, 2025 updated by: Bushra Akram, Islamia University of Bahawalpur
Efficacy of Cognitive Behavior Therapy, Pelvic Floor Therapy and Pharmacotherapy in the Treatment of Chronic Pelvic Pain in Women: A Comparative Study
The study will employ 4 treatment arms and 1 placebo arm to compare efficacy of CBT, PFT, Pharmacotherapy, Integrated CBT and PFT modalities in the management of chronic pelvic pain in women.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Women of reproductive age, Women with CPP having no pathological or anatomical causes, Women with Overactive Bladder Syndrome Women with Vulvodynia.
Exclusion Criteria:
Women experiencing per-menopause or menopause, Women with medical, or gynecological or hormonal abnormalities, Women with mental disorders, Women who use substances.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
The participants in placebo arm will receive sham drug.
|
|
Experimental: Cognitive Behavior Therapy for Chronic Pain (CBT-cp)
|
The participants in CBT-cp arm will receive weekly sessions of Cognitive Behavior Therapy for Chronic Pain.
|
|
Experimental: Pelvic Floor Therapy (PFT)
|
The participants in PFT arm will receive weekly sessions of pelvic floor therapy.
|
|
Experimental: Pharmacotherapy
|
The participants in Pharmacotherapy arm will receive prescription and non prescription pain medication.
|
|
Experimental: Integrated CBT-cp and PFT
|
The participants in integrated arm will receive weekly sessions of both CBT-cp and PFT.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ)
Time Frame: Up to 12 weeks
|
Up to 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 10, 2025
Primary Completion (Estimated)
December 30, 2025
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
June 20, 2025
First Submitted That Met QC Criteria
June 20, 2025
First Posted (Actual)
June 29, 2025
Study Record Updates
Last Update Posted (Actual)
June 29, 2025
Last Update Submitted That Met QC Criteria
June 20, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IslUB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.