Depression, Anxiety, Pelvic Pain
Conditions
Keywords
Acceptance and Commitment Therapy, Women Veterans, Primary Care
Brief 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.
Interventions
BEHAVIORALBrief 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.
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of recruitment | Up to 1 year | Recruitment rates (number enrolled/number who complete treatment) |
| Acceptability of intervention | 2-month follow-up | Open-ended question about how satisfactory veterans find the intervention (including likes, dislikes, and recommendations for improving the intervention) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change score in McGill Pain Questionnaire | Change at 2-month follow-up from baseline | The McGill Pain Questionnaire assesses pain intensity and type. Scores range from 0-100 with higher scores reflecting greater pain severity. |
| Mean change in Short Form Veteran Health Survey (VR-12) | Change at 2-month follow-up from baseline | The VR-12 is a short-form measures self-reported health and functioning. Higher scaled scores indicate greater functional impairment. |
| Mean change score in Patient Health Questionnaire (PHQ-9) | Change at 2-month follow-up from baseline | The 9-item PHQ-9 measures severity of depressive symptoms. Scores range from 0-36 with higher scores reflecting greater symptom severity. |
| Mean change score in Generalized Anxiety Disorder Scale (GAD-7) | Change at 2-month follow-up from baseline | The 7-item GAD-7 measures severity of anxiety symptoms. Scores range from 0-28 with higher scores reflecting greater symptom severity. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean change score in Chronic Pain Acceptance Questionnaire (CPAQ-Revised) | Change at 2-month follow-up from baseline | 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. |
| Mean change score in Chronic Pain Values Inventory (CPVI) | Change at 2-month follow-up from baseline | 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. |
Countries
United States
Outcome results
None listed