Restoring Emotional, Sexual, and Physical Empowerment Through CBT & Trauma-sensitive Care: A Chronic Pelvic Pain Intervention (RESPECT)

November 19, 2021 updated by: Rush University Medical Center
This project will develop and preliminarily examine RESPECT, a trauma-sensitive psychological and physical therapy intervention to treat chronic pelvic pain, posttraumatic stress symptoms (PTS), and dysfunctional sexual behavior among women with sexual abuse histories. Patients will be recruited after being referred to pelvic floor physical therapy for treatment of chronic pelvic pain. Participants will complete seven sessions of individual cognitive behavioral psychotherapy. Physical therapy will be provided by clinicians who have been trained in trauma-sensitive treatment techniques. Treatment acceptability and outcomes will be assessed at baseline, mid intervention, post-intervention and follow-up via self-report measures. The RESPECT protocol is expected to be feasible to implement among sexual abuse survivors and to be well liked by patients. RESPECT is expected to reduce chronic pelvic pain, PTS, dysfunctional sexual behavior, treatment avoidance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This project will develop and preliminarily examine RESPECT, a trauma-sensitive psychological and physical therapy intervention to treat chronic pelvic pain, posttraumatic stress symptoms (PTS), and dysfunctional sexual behavior among women with sexual abuse histories. Chronic pelvic pain disorders are highly prevalent in the U.S., affecting between 10-21% of premenopausal women at some time in their lives. Chronic pelvic pain is associated with dyspareunia, depression, anxiety, relationship distress, functional impairment and poor quality of life. History of sexual abuse is associated with development of chronic pelvic pain and with the severity of psychological distress and functional impairment among chronic pain patients.

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).

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush UMC Outpatient Physical Therapy Clinic

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Fluent in English
  • 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 menstruating for reasons other than birth control
  • 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trauma-sensitive Care
Participants will attend 7, one-hour psychotherapy sessions, which will be concurrent with trauma-sensitive care at physical therapy appointments.
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic pelvic pain
Time Frame: 4 months
Women will be asked to rate the severity of their pain during a variety of activities (e.g., pain at ovulation, pain while lifting) on a 10-point scale (0 = no pain, 10 = worst pain imaginable). Difference measured from pre to post intervention
4 months
Posttraumatic stress (PTS) - The 20-item PTSD Checklist for DSM-5 will be used to assess symptoms of Posttraumatic Stress Disorder. Items are rated on a 5-point Likert (scale with greater scores indicating more severe symptomatology
Time Frame: 4 months
Difference from pre to post intervention
4 months
Sexual History FOrm
Time Frame: 4 months
The SHF will be used to assess participants' sexual history. The Female Sexual Function Index will assess participant's sexual feelings and responses. Women are asked 37 questions. Difference measured from pre to post intervention
4 months
Treatment avoidance
Time Frame: 4 months
Women's pelvic floor functioning will be assessed by collecting data from patient's medical records which is typically recorded as part of routine clinical practice. Difference measured from pre to post intervention
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Investigators

  • Principal Investigator: Vanessa Tirone, Ph.D., Rush University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

October 1, 2015

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

September 24, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Actual)

December 2, 2021

Last Update Submitted That Met QC Criteria

November 19, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15050501-IRB01

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.

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