Pelvic PainNCT06062043
Pelvic Pain Education and Skills Training for Women Veterans
A study testing Brief ACT with CPP Education Treatment in people with Pelvic Pain and Distress, Emotional, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The goals of this pilot randomized clinical trial are three-fold: 1) to test the feasibility of conducting a larger randomized trial using a brief Acceptance and Commitment Training (ACT) group intervention for women veterans with pelvic pain compared to usual care; 2) assess treatment acceptability by women veterans… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Pain, Distress, Emotional
- What is being tested?
- Brief ACT with CPP Education Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2024to 15 Jan 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Served in US Armed Forces
- Self-identify as female/woman
- Have a diagnosis of chronic pelvic pain (CPP)
- Endorse moderate to severe pain (worst pain score ≥ 4 on Numeric Rating Scale [NRS]) AND pain-related distress (score ≥ 80 on Pelvic Floor Distress Inventory [PFDI-20])
- Be stable on mood and pain medication for four weeks and not scheduled for medical tests or procedures that might influence pain-related outcomes (e.g., surgical interventions, nerve block treatments)
Who cannot join
- Cognitive impairment
- Uncontrolled bipolar or psychotic diagnosis
- Active suicidal or homicidal ideation
- Receiving concurrent psychotherapy or who have received Acceptance and Commitment Therapy (ACT) within the past year
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
About this study
Official title: Pelvic Pain Education and Skills Training for Women Veterans - Pilot Study
The goals of this pilot randomized clinical trial are three-fold: 1) to test the feasibility of conducting a larger randomized trial using a brief Acceptance and Commitment Training (ACT) group intervention for women veterans with pelvic pain compared to usual care; 2) assess treatment acceptability by women veterans, and 3) identify appropriate pain-related treatment outcomes for the larger randomized trial.
Participants will be randomly assigned to participate in either the ACT condition or treatment as usual condition, complete three surveys (before, after, and 3-months after first survey), and complete a phone interview (if assigned to the ACT condition).
Researchers will compare the ACT condition and treatment as usual condition to see if there are meaningful differences in health outcomes. Due to the small sample size and pilot nature of this study, significance testing will not be performed.
Read the detailed description
Chronic pelvic pain (CPP) is a debilitating pain condition that disproportionately affects women veterans (30% vs. 16% of nonveteran women vs. 3% of men). Pain intensity and disability are further exacerbated by psychosocial factors (such as depression, anxiety, posttraumatic distress) that may not be fully addressed through pharmacological and surgical interventions. Cognitive and behavioral therapies, such as Acceptance and Commitment Therapy (ACT), are identified as first-line nondrug treatments for pain conditions. Given the multifactorial nature of CPP, ACT may be of particular benefit to these patients as it provides a unified (transdiagnostic) approach to the treatment of co-occurring disorders, such as chronic pain, depression, and anxiety. Specifically, ACT targets core psychological and behavioral factors (e.g., avoidance) that underlie many psychiatric and medical conditions. Several meta-analyses show ACT is effective, even when compared to active interventions such as Cognitive-Behavioral Therapy.
In this pilot study, researchers will examine the feasibility and acceptability of conducting a larger randomized controlled trial to establish the efficacy of a brief ACT group treatment for women veterans experiencing pelvic pain. This pilot study builds on previous work adapting an empirically supported one-day ACT workshop to the specific needs of women veterans based on their feedback.
- Conditions
- Pelvic Pain, Distress, Emotional
- Being tested
- Brief ACT with CPP Education Treatment
- Keywords
- Acceptance and Commitment Therapy, Women Veterans, Primary Care, Pain management
- Medical subject headings
- Pelvic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief ACT with CPP Education TreatmentBehavioural
Also called Brief ACT for Pelvic Pain
The Brief ACT with CPP Education treatment provides women veterans with new ways of responding to difficult thoughts and emotions related to pain while also encouraging them to engage in meaningful life activities. The CPP educational component includes information about pathology, risk factors, health outcomes, and treatment that are specific to women's biological and reproductive functioning. Treatment content has been further tailored to reflect the cultural experiences of women veterans (including discussions on the interplay between military culture, perceived social norms, and gender role expectations).
| Study group | Role | What they receive |
|---|---|---|
| Brief ACT with CPP Education Group | Experimental | The Brief Acceptance and Commitment Training (ACT) with Chronic Pelvic Pain (CPP) education Group will attend weekly 90-minute sessions for up to six weeks to learn new ways to respond to their pain and engage in meaningful activities. Receives: Behavioral: Brief ACT with CPP Education Treatment |
| Enhanced Treatment as Usual | No intervention | The enhanced treatment as usual (TAU) condition will receive a letter with CPP-specific treatment resources and encouraged to consult with their VHA primary care clinicians for additional education and treatment options. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
Recruitment rates (number of women veterans enrolled/number who complete treatment)
Measured: Up to 1 year
Acceptability of intervention
Qualitative interview inquiring about how satisfactory women veterans found the intervention (such as likes, dislikes, and suggestions for improvement)
Measured: 3-month follow-up
Client Satisfaction Questionnaire (CSQ-8)
The 8 item CSQ-8 measures patient satisfaction with services rendered. Scores range from 8 to 32. Higher scores indicate greater satisfaction.
Measured: up to 8-weeks from baseline
Secondary outcomes (3)
Mean change score in Pelvic Floor Distress Inventory (PFDI-20)
The 20 item PFDI-20 measures emotional distress related to pelvic pain symptoms. Scores range from 0-300. Higher scores indicate greater pelvic pain-related distress.
Measured: Change at 3-month follow-up from baseline
Mean change score in Brief Pain Inventory (BPI-SF), Pain Interference Scale
The 7 item BPI-SF, Pain Interference Scale measures level of pain interference in daily activities. Items are averaged to compute a mean scale score that ranges from 0 to 10. Higher scores indicate greater interference with daily activities.
Measured: Change at 3-month follow-up from baseline
Mean change in Numeric Rating Scale (NRS)
This single item will measure worst pain severity in past 7 days. Scores range from 0-10. Higher scores indicate greater pain severity.
Measured: Change at 3-month follow-up from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start4 Mar 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Derrecka Boykin, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062043
- Sponsor's protocol ID
- H-53941
- Status last verified
- May 2025
- First submitted
- 12 Sep 2023
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Pain Education and Skills Training for Women Veterans - Pilot Study
- ClinicalTrials.gov ID
- NCT06062043
- Acronym / sponsor ID
- H-53941
- Conditions
- Pelvic Pain, Distress, Emotional
- Keywords
- Acceptance and Commitment Therapy, Women Veterans, Primary Care, Pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 2 Oct 2023 (actual)
- 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 goals of this pilot randomized clinical trial are three-fold: 1) to test the feasibility of conducting a larger randomized trial using a brief Acceptance and Commitment Training (ACT) group intervention for women veterans with pelvic pain compared to usual care; 2) assess treatment acceptability by women veterans, and 3) identify appropriate pain-related treatment outcomes for the larger randomized trial.
Participants will be randomly assigned to participate in either the ACT condition or treatment as usual condition, complete three surveys (before, after, and 3-months after first survey), and complete a phone interview (if assigned to the ACT condition).
Researchers will compare the ACT condition and treatment as usual condition to see if there are meaningful differences in health outcomes. Due to the small sample size and pilot nature of this study, significance testing will not be performed.
Detailed description
Chronic pelvic pain (CPP) is a debilitating pain condition that disproportionately affects women veterans (30% vs. 16% of nonveteran women vs. 3% of men). Pain intensity and disability are further exacerbated by psychosocial factors (such as depression, anxiety, posttraumatic distress) that may not be fully addressed through pharmacological and surgical interventions. Cognitive and behavioral therapies, such as Acceptance and Commitment Therapy (ACT), are identified as first-line nondrug treatments for pain conditions. Given the multifactorial nature of CPP, ACT may be of particular benefit to these patients as it provides a unified (transdiagnostic) approach to the treatment of co-occurring disorders, such as chronic pain, depression, and anxiety. Specifically, ACT targets core psychological and behavioral factors (e.g., avoidance) that underlie many psychiatric and medical conditions. Several meta-analyses show ACT is effective, even when compared to active interventions such as Cognitive-Behavioral Therapy.
In this pilot study, researchers will examine the feasibility and acceptability of conducting a larger randomized controlled trial to establish the efficacy of a brief ACT group treatment for women veterans experiencing pelvic pain. This pilot study builds on previous work adapting an empirically supported one-day ACT workshop to the specific needs of women veterans based on their feedback.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief ACT with CPP Education Group | Experimental | Behavioral: Brief ACT with CPP Education TreatmentThe Brief Acceptance and Commitment Training (ACT) with Chronic Pelvic Pain (CPP) education Group will attend weekly 90-minute sessions for up to six weeks to learn new ways to respond to their pain and engage in meaningful activities. |
| Enhanced Treatment as Usual | No intervention | –The enhanced treatment as usual (TAU) condition will receive a letter with CPP-specific treatment resources and encouraged to consult with their VHA primary care clinicians for additional education and treatment options. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Served in US Armed Forces
- Self-identify as female/woman
- Have a diagnosis of chronic pelvic pain (CPP)
- Endorse moderate to severe pain (worst pain score ≥ 4 on Numeric Rating Scale [NRS]) AND pain-related distress (score ≥ 80 on Pelvic Floor Distress Inventory [PFDI-20])
- Be stable on mood and pain medication for four weeks and not scheduled for medical tests or procedures that might influence pain-related outcomes (e.g., surgical interventions, nerve block treatments)
Key exclusion criteria (4 listed)
- Cognitive impairment
- Uncontrolled bipolar or psychotic diagnosis
- Active suicidal or homicidal ideation
- Receiving concurrent psychotherapy or who have received Acceptance and Commitment Therapy (ACT) within the past year
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 ACT with CPP Education TreatmentAlso: Brief ACT for Pelvic PainThe Brief ACT with CPP Education treatment provides women veterans with new ways of responding to difficult thoughts and emotions related to pain while also encouraging them to engage in meaningful life activities. The CPP educational component includes information about pathology, risk factors, health outcomes, and treatment that are specific to women's biological and reproductive functioning. Treatment content has been further tailored to reflect the cultural experiences of women veterans (including discussions on the interplay between military culture, perceived social norms, and gender role expectations). | Behavioural | Brief ACT with CPP Education Group |
Primary outcome
Feasibility of recruitment
Time frame: Up to 1 year
Recruitment rates (number of women veterans enrolled/number who complete treatment)
Acceptability of intervention
Time frame: 3-month follow-up
Qualitative interview inquiring about how satisfactory women veterans found the intervention (such as likes, dislikes, and suggestions for improvement)
Client Satisfaction Questionnaire (CSQ-8)
Time frame: up to 8-weeks from baseline
The 8 item CSQ-8 measures patient satisfaction with services rendered. Scores range from 8 to 32. Higher scores indicate greater satisfaction.
3 secondary outcomes
Mean change score in Pelvic Floor Distress Inventory (PFDI-20)
Time frame: Change at 3-month follow-up from baseline
Mean change score in Brief Pain Inventory (BPI-SF), Pain Interference Scale
Time frame: Change at 3-month follow-up from baseline
Mean change in Numeric Rating Scale (NRS)
Time frame: Change at 3-month follow-up from baseline
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 21 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief ACT with CPP Education Treatment in people with Pelvic Pain and Distress, Emotional, run by Baylor College of Medicine at 1 site in United States.
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 5 inclusion and 4 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 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Feasibility of recruitment (time frame: Up to 1 year). The study lists 3 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 21 May 2025.