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

NCT02588885 | Completed

• 1 other identifier: 15050501-IRB01
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Pain; Stress Disorders, Traumatic

Keywords

physical therapy; psychotherapy; dysfunctional sexual behavior; pelvic pain; posttraumatic stress; PTSD; chronic pain

Outcome Measures

Primary Outcomes (4)

• Chronic pelvic pain

  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

  Difference from pre to post intervention

  4 months

• Sexual History FOrm

  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

  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

Study Arms (1)

Trauma-sensitive Care

EXPERIMENTAL

Participants will attend 7, one-hour psychotherapy sessions, which will be concurrent with trauma-sensitive care at physical therapy appointments.

Behavioral: Trauma-sensitive Care

Interventions

Trauma-sensitive Care BEHAVIORAL

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

Trauma-sensitive Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush UMC Outpatient Physical Therapy Clinic

Chicago, Illinois, 60612, United States

Location

Related Publications (24)

• Armour C, Tsai J, Durham TA, Charak R, Biehn TL, Elhai JD, Pietrzak RH. Dimensional structure of DSM-5 posttraumatic stress symptoms: support for a hybrid Anhedonia and Externalizing Behaviors model. J Psychiatr Res. 2015 Feb;61:106-13. doi: 10.1016/j.jpsychires.2014.10.012. Epub 2014 Nov 22.

  PMID: 25479765 BACKGROUND

• Chandler HK, Ciccone DS, Raphael KG. Localization of pain and self-reported rape in a female community sample. Pain Med. 2006 Jul-Aug;7(4):344-52. doi: 10.1111/j.1526-4637.2006.00185.x.

  PMID: 16898946 BACKGROUND

• Jamieson DJ, Steege JF. The prevalence of dysmenorrhea, dyspareunia, pelvic pain, and irritable bowel syndrome in primary care practices. Obstet Gynecol. 1996 Jan;87(1):55-8. doi: 10.1016/0029-7844(95)00360-6.

  PMID: 8532266 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA. 1999 Feb 10;281(6):537-44. doi: 10.1001/jama.281.6.537.

  PMID: 10022110 BACKGROUND

• Latthe P, Latthe M, Say L, Gulmezoglu M, Khan KS. WHO systematic review of prevalence of chronic pelvic pain: a neglected reproductive health morbidity. BMC Public Health. 2006 Jul 6;6:177. doi: 10.1186/1471-2458-6-177.

  PMID: 16824213 BACKGROUND

• Lang AJ, Stein MB. An abbreviated PTSD checklist for use as a screening instrument in primary care. Behav Res Ther. 2005 May;43(5):585-94. doi: 10.1016/j.brat.2004.04.005.

  PMID: 15865914 BACKGROUND

• Leclerc B, Bergeron S, Binik YM, Khalife S. History of sexual and physical abuse in women with dyspareunia: association with pain, psychosocial adjustment, and sexual functioning. J Sex Med. 2010 Feb;7(2 Pt 2):971-80. doi: 10.1111/j.1743-6109.2009.01581.x. Epub 2009 Nov 13.

  PMID: 19912492 BACKGROUND

• Mark H, Bitzker K, Klapp BF, Rauchfuss M. Gynaecological symptoms associated with physical and sexual violence. J Psychosom Obstet Gynaecol. 2008 Sep;29(3):164-72. doi: 10.1080/01674820701832770.

  PMID: 18821266 BACKGROUND

• Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.

  PMID: 1393159 BACKGROUND

• Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF. Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996 Mar;87(3):321-7. doi: 10.1016/0029-7844(95)00458-0.

  PMID: 8598948 BACKGROUND

• McWilliams LA, Kowal J, Wilson KG. Development and evaluation of short forms of the Pain Catastrophizing Scale and the Pain Self-efficacy Questionnaire. Eur J Pain. 2015 Oct;19(9):1342-9. doi: 10.1002/ejp.665. Epub 2015 Mar 11.

  PMID: 25766681 BACKGROUND

• Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.

  PMID: 16446108 BACKGROUND

• Nicholson LM, Schwirian PM, Klein EG, Skybo T, Murray-Johnson L, Eneli I, Boettner B, French GM, Groner JA. Recruitment and retention strategies in longitudinal clinical studies with low-income populations. Contemp Clin Trials. 2011 May;32(3):353-62. doi: 10.1016/j.cct.2011.01.007. Epub 2011 Jan 27.

  PMID: 21276876 BACKGROUND

• Osman A, Barrios FX, Kopper BA, Hauptmann W, Jones J, O'Neill E. Factor structure, reliability, and validity of the Pain Catastrophizing Scale. J Behav Med. 1997 Dec;20(6):589-605. doi: 10.1023/a:1025570508954.

  PMID: 9429990 BACKGROUND

• Postma R, Bicanic I, van der Vaart H, Laan E. Pelvic floor muscle problems mediate sexual problems in young adult rape victims. J Sex Med. 2013 Aug;10(8):1978-87. doi: 10.1111/jsm.12196. Epub 2013 May 16.

  PMID: 23679151 BACKGROUND

• Powers A, Fani N, Pallos A, Stevens J, Ressler KJ, Bradley B. Childhood abuse and the experience of pain in adulthood: the mediating effects of PTSD and emotion dysregulation on pain levels and pain-related functional impairment. Psychosomatics. 2014 Sep-Oct;55(5):491-9. doi: 10.1016/j.psym.2013.10.004. Epub 2013 Oct 23.

  PMID: 24360527 BACKGROUND

• Rapaport MH, Clary C, Fayyad R, Endicott J. Quality-of-life impairment in depressive and anxiety disorders. Am J Psychiatry. 2005 Jun;162(6):1171-8. doi: 10.1176/appi.ajp.162.6.1171.

  PMID: 15930066 BACKGROUND

• Reed BD, Haefner HK, Punch MR, Roth RS, Gorenflo DW, Gillespie BW. Psychosocial and sexual functioning in women with vulvodynia and chronic pelvic pain. A comparative evaluation. J Reprod Med. 2000 Aug;45(8):624-32.

  PMID: 10986680 BACKGROUND

• Tripoli TM, Sato H, Sartori MG, de Araujo FF, Girao MJ, Schor E. Evaluation of quality of life and sexual satisfaction in women suffering from chronic pelvic pain with or without endometriosis. J Sex Med. 2011 Feb;8(2):497-503. doi: 10.1111/j.1743-6109.2010.01976.x. Epub 2010 Aug 16.

  PMID: 20722779 BACKGROUND

• UyBico SJ, Pavel S, Gross CP. Recruiting vulnerable populations into research: a systematic review of recruitment interventions. J Gen Intern Med. 2007 Jun;22(6):852-63. doi: 10.1007/s11606-007-0126-3. Epub 2007 Mar 21.

  PMID: 17375358 BACKGROUND

• Van Damme S, Crombez G, Bijttebier P, Goubert L, Van Houdenhove B. A confirmatory factor analysis of the Pain Catastrophizing Scale: invariant factor structure across clinical and non-clinical populations. Pain. 2002 Apr;96(3):319-324. doi: 10.1016/S0304-3959(01)00463-8.

  PMID: 11973004 BACKGROUND

• Walker EA, Newman E, Koss M, Bernstein D. Does the study of victimization revictimize the victims? Gen Hosp Psychiatry. 1997 Nov;19(6):403-10. doi: 10.1016/s0163-8343(97)00061-3.

  PMID: 9438184 BACKGROUND

• Zondervan K, Barlow DH. Epidemiology of chronic pelvic pain. Baillieres Best Pract Res Clin Obstet Gynaecol. 2000 Jun;14(3):403-14. doi: 10.1053/beog.1999.0083.

  PMID: 10962634 BACKGROUND

MeSH Terms

Conditions

Pelvic Pain; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Vanessa Tirone, Ph.D.

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: October 28, 2015
• Study Start: October 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: December 2, 2021

Record last verified: 2021-11

Locations

US (1)