Life-Stress Interview for Women With Chronic Urogenital Pain Conditions

Study Overview
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Brief Summary
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The goal of this study is to test the efficacy, feasibility, and acceptability of providing an experiential assessment interview that targets health, and emotional and stressful experiences in a tertiary care setting specializing in women's urology.

Detailed Description
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In this randomized, controlled trial, the investigators will compare an interview condition to a wait-list control condition. The investigators hypothesize that helping individuals identify the links between their stress, emotions, and physical symptoms will likely increase their awareness and endorsement of the link between stress and physical symptoms, including a willingness to engage in stress management techniques. It is also expected that helping raise an individual's awareness about their symptoms, followed by an experience and expression of unexpressed emotion is likely to influence their physical and psychological well-being.

Official Title
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Life-Stress Interview for Women With Chronic Urogenital Pain Conditions

Conditions
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Chronic Urogenital Pain

Intervention / Treatment
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* Behavioral: Life-Stress Interview


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must have a chronic urogenital pain condition Exclusion Criteria: non-English speaking unable to read psychosis dementia mental impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Life-Stress Interview<br>The Life-Stress Interview is an experiential assessment technique | Behavioral: Life-Stress Interview<br>* A life-stress interview which aims to help patients: a) disclose their stressful experiences and emotional conflicts, which might be contributing to their symptoms, b) learn about associations between their stress and physical symptoms; and c) learn about the potential value of experiencing and expressing their emotions related to these stressful situations<br>|
| No Intervention: Wait-list Control<br>Wait-list Control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Interpretation Questionnaire (SIQ) |  | Change from baseline symptom attribution at 6-weeks | 
| Brief Pain Inventory (BPI) |  | Change from baseline pain at 6-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-15 (PHQ-15) |  | Change from baseline in symptom severity at 6 weeks | 
| Brief Symptom Inventory (BSI) |  | Change from baseline symptoms at 6-weeks | 
| Satisfaction With Life Scale (SWLS) |  | Change from baseline life satisfaction at 6-weeks | 
| Pelvic Floor Distress Inventory -20 (PFDI-20) |  | Change from baseline pelvic symptoms at 6-weeks | 
| Global Assessment Response (GRA) |  | Change from baseline overall symptoms at 6-weeks | 
| Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) |  | Change from baseline pain at 6-weeks | 
| Emotional Approach Coping (EAC) |  | Change from baseline emotional approach coping at 6-weeks | 
| Emotional Processing Scale-25 (EPS-25) |  | Change from baseline emotional processing at 6-weeks | 
| Inventory of Interpersonal Problems-32 (IIP-32) |  | Change from baseline interpersonal problems at 6-weeks | 
| Pain Catastrophizing Scale |  | Change from baseline pain catastrophizing at 6-weeks | 
| Change Assessment Questionnaire |  | Change from baseline stage of change at 6-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pelvic Pain, Interstitial Cystitis, Vulvodynia, Dyspareunia, Pelvic Floor Dysfunction, Emotional Processing