Restoring Emotional, Sexual, and Physical Empowerment Through CBT & Trauma-sensitive Care: A Chronic Pelvic Pain Intervention
NCT ID: NCT02588885
Last Updated: 2021-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2015-10-31
2019-11-30
Brief Summary
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Detailed Description
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Unfortunately, frontline chronic pelvic pain treatments such as physical therapy and pain-specific psychological interventions fail to address sexual trauma. Standard physical therapy may actually trigger trauma related symptoms because it involves invasive techniques including internal digital palpation of pelvic floor muscles and the use of vaginal dilators. Neglecting trauma in chronic pelvic pain treatment could contribute to poor treatment outcomes, low adherence, and drop out. RESPECT's trauma-sensitive psychological intervention will teach women skills to cope with PTS, pain, sexual dysfunction, and discomfort during physical therapy. RESPECT's trauma-sensitive physical therapy intervention will more sensitively apply the invasive aspects of treatment and reinforce women's use of trauma-related coping skills learned in the psychological intervention. RESPECT is predicted to decrease chronic pelvic pain, PTS, dysfunctional sexual behavior, treatment avoidance.
Study Aims
1. Develop a multi-level trauma-sensitive (psychological and physical therapy) chronic pelvic pain intervention for inner-city women with histories of sexual abuse and PTS symptoms.
2. Examine the feasibility of RESPECT in treating this population.
3. Use a pilot open trial to examine the impact of RESPECT chronic pelvic pain, PTS, dysfunctional sexual behavior, treatment avoidance.
RESPECT's trauma-sensitive psychological intervention will 1) educate the patient about the relations between sexual abuse, PTS, and chronic pelvic pain 2) empower her by explaining that sexual abuse, chronic pelvic pain, and PTS are not her fault but she has the power to combat them 3) desensitize her to anxiety provoking components of the physical therapy intervention, and 4) teach her relaxation tools that she can use during physical therapy sessions, while practicing at-home physical therapy exercises, and to cope with pain more generally.
RESPECT's trauma-sensitive physical therapy intervention will 1) teach the patient techniques to address muscular tension that contributes to chronic pelvic pain 2) empower her by increasing her control over each phase of treatment (e.g., starting, stopping, expressing feelings and preferences) 3) comfort her by explaining that it is normal to experience discomfort during physical therapy treatment and 4) encourage her to use the trauma-related coping skills she learned in the psychotherapy component.
This initial project is intended to lead to a larger open trial that will examine not only treatment outcomes, but also the mechanisms of change (e.g., women's feeling of empowerment, decrease in PTS symptoms).
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Trauma-sensitive Care
Participants will attend 7, one-hour psychotherapy sessions, which will be concurrent with trauma-sensitive care at physical therapy appointments.
Trauma-sensitive Care
Psychological intervention
1. education
2. empowerment
3. desensitization
4. relaxation tools
Physical therapy intervention
1. techniques to address muscular tension
2. empowerment
3. comfort
4. encouragement of trauma-related coping skills
Interventions
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Trauma-sensitive Care
Psychological intervention
1. education
2. empowerment
3. desensitization
4. relaxation tools
Physical therapy intervention
1. techniques to address muscular tension
2. empowerment
3. comfort
4. encouragement of trauma-related coping skills
Eligibility Criteria
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Inclusion Criteria
* History of sexual abuse
* Premenopausal
* Chronic pelvic pain defined as pelvic pain with a duration of six months of at least a moderate severity
Exclusion Criteria
* Not currently receiving any current trauma-focused psychological treatment (i.e., prolonged exposure therapy, cognitive processing therapy, eye movement desensitization reprocessing)
* No current psychotic symptoms or current use of anti-psychotic medications
* No current suicidal ideation in the past month
* Not currently pregnant
18 Years
FEMALE
No
Sponsors
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Rush University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Vanessa Tirone, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center
Locations
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Rush UMC Outpatient Physical Therapy Clinic
Chicago, Illinois, United States
Countries
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References
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Other Identifiers
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15050501-IRB01
Identifier Type: -
Identifier Source: org_study_id