Life-Stress Interview for Women With Chronic Urogenital Pain Conditions

Not Applicable

Completed

• Conditions: Chronic Urogenital Pain
• Interventions: Behavioral: Life-Stress Interview

• Registration Number: NCT02286115
• Lead Sponsor: William Beaumont Hospitals

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-11-05
• Study First Submitted QC: 2014-11-05
• Study First Posted: 2014-11-07
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-13
• Last Update Posted: 2016-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Participants must have a chronic urogenital pain condition

Exclusion Criteria

• non-English speaking
• unable to read
• psychosis
• dementia
• mental impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Life-Stress Interview	Life-Stress Interview	The Life-Stress Interview is an experiential assessment technique

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Women's Urology Center; 🇺🇸 Royal Oak, Michigan, United States