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

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ClinicalTrials.gov Identifier: NCT02588885
Recruitment Status : Unknown
Verified October 2015 by Rush University Medical Center.
Recruitment status was:  Recruiting
First Posted : October 28, 2015
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pelvic Pain Stress Disorders, Traumatic Behavioral: Trauma-sensitive Care Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Restoring Emotional, Sexual, and Physical Empowerment Through CBT & Trauma-sensitive Care: A Chronic Pelvic Pain Intervention
Study Start Date : October 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588885


Contacts
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Contact: Vanessa Tirone, Ph.D. vanessa_tirone@rush.edu
Contact: Jennifer Siedjak, B.A.

Locations
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United States, Illinois
Rush UMC Outpatient Physical Therapy Clinic Recruiting
Chicago, Illinois, United States, 60612
Contact: Diane Genaze    312-942-5661      
Contact: Charles Cranny    3125634199      
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Vanessa Tirone, Ph.D. Rush University Medical Center

Publications:

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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02588885    
Other Study ID Numbers: 15050501-IRB01
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015
Keywords provided by Rush University Medical Center:
physical therapy
psychotherapy
dysfunctional sexual behavior
pelvic pain
posttraumatic stress
PTSD
chronic pain
Additional relevant MeSH terms:
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Pelvic Pain
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Pain
Neurologic Manifestations
Signs and Symptoms