Chronic Pelvic Pain and Education Skills Training for Women Veterans

Depression, Anxiety Clinical Trial

Official title:

Chronic Pelvic Pain and Education Skills Training for Women Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05368155
• Other study ID #: H-51197
• Status: Completed
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: February 20, 2023

Study information

• Verified date: March 2023
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic pelvic pain (CPP) is a debilitating condition that disproportionately affects women Veterans (25% vs. 16% of civilian women). Predisposing factors include higher rates of strenuous physical activity during military service, duty-related injuries, psychiatric distress, and sexual trauma. CPP is associated with a high burden of illness, disability, and economic costs (estimated at $5.8 billion in annual health care expenditures).

Multimodal, interdisciplinary approaches are emphasized in the treatment of CPP. Psychological interventions are essential for optimizing pain self-management for CPP. Psychosocial factors are known to affect pain intensity and recovery. Women Veterans report higher rates of depression and anxiety with CPP, that leads to greater disability and poorer quality of life. Cognitive and behavioral therapies, such as Acceptance and Commitment Therapy (ACT), are effective options for pain self-management. Barriers to effective pain treatment are high attrition and non-adherence. Additionally, women Veterans prefer treatments that address their gender-specific needs. Gender-specific services remain limited in the Veterans Health Administration (VHA).

In line with VHA's priorities to expand women's health care, this study implements ACT in a brief intervention format to address a highly prevalent reproductive health issue among women Veterans. ACT is transdiagnostic and thus provides a unified approach to the treatment of co-occurring disorders, such as chronic pain, depression, and anxiety. Brief workshop formats increase treatment completion and patient engagement. This study seeks to adapt an existing 1-day ACT workshop for use in VHA integrated primary care (PCMHI) and specialty medical settings with women veterans experiencing CPP. Primary outcomes are feasibility and acceptability of the adapted intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 20, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being a Veteran

• Being female

• Having a diagnosis of chronic pelvic pain

• Endorsing severe pain (score = 7 on Brief Pain Inventory [BPI]) or moderate to severe pain plus clinically significant psychological distress (score = 3 on BPI and score = 10 on Patient Health Questionnaire-9 [PHQ-9] or Generalized Anxiety Disorder-7 [GAD-7])

Exclusion Criteria:

• Cognitive impairment

• An uncontrolled bipolar or psychotic diagnosis

• Active suicidal ideation

• Receiving concurrent psychotherapy or who have received ACT within the past year

Related Conditions & MeSH terms

• Depression, Anxiety
• Pelvic Pain

Intervention

Behavioral:
• Brief ACT for Pelvic Pain
The Brief ACT for Pelvic Pain treatment will include three weekly, 90-minute group sessions that teach Veterans new ways to respond to difficult thoughts and emotions related to pain (Acceptance and Mindfulness Training) and encourage behavioral (re)engagement in meaningful life activities (Behavioral Change Training). The overall goal is to cultivate psychological flexibility by helping Veterans learn to respond to life events in ways which do not exacerbate difficulties or restrict engagement in meaningful activities. Workshop content is integrated with education on pelvic pain (its diagnostic criteria, etiology, and associated health outcomes) to increase alignment of the treatment with patient needs.

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean change score in Chronic Pain Acceptance Questionnaire (CPAQ-Revised)	The 20-item CPAQ-revised is designed to measure acceptance of pain, which is thought to reduce unsuccessful attempts to avoid or control pain and thus focus on engaging in valued activities and pursuing meaningful goals. Scores range from 0-120 with higher scores reflecting greater pain acceptance.	Change at 2-month follow-up from baseline
Other	Mean change score in Chronic Pain Values Inventory (CPVI)	The 12-item CPVI measures which values are important to an individual and the degree of success they are having in following their values. Two average scores are created (mean success and mean discrepancy ratings) that range from 0-5. Higher mean scores reflect greater success or greater discrepancy between importance of value and success in achieving it.	Change at 2-month follow-up from baseline
Primary	Feasibility of recruitment	Recruitment rates (number enrolled/number who complete treatment)	Up to 1 year
Primary	Acceptability of intervention	Open-ended question about how satisfactory veterans find the intervention (including likes, dislikes, and recommendations for improving the intervention)	2-month follow-up
Secondary	Mean change score in Patient Health Questionnaire (PHQ-9)	The 9-item PHQ-9 measures severity of depressive symptoms. Scores range from 0-36 with higher scores reflecting greater symptom severity.	Change at 2-month follow-up from baseline
Secondary	Mean change score in Generalized Anxiety Disorder Scale (GAD-7)	The 7-item GAD-7 measures severity of anxiety symptoms. Scores range from 0-28 with higher scores reflecting greater symptom severity.	Change at 2-month follow-up from baseline
Secondary	Mean change score in McGill Pain Questionnaire	The McGill Pain Questionnaire assesses pain intensity and type. Scores range from 0-100 with higher scores reflecting greater pain severity.	Change at 2-month follow-up from baseline
Secondary	Mean change in Short Form Veteran Health Survey (VR-12)	The VR-12 is a short-form measures self-reported health and functioning. Higher scaled scores indicate greater functional impairment.	Change at 2-month follow-up from baseline