Overview

This trial is active, not recruiting.

Condition chronic urogenital pain
Treatment life-stress interview
Sponsor William Beaumont Hospitals
Collaborator Wayne State University
Start date September 2014
End date December 2015
Trial size 70 participants
Trial identifier NCT02286115, HIC.2014-151

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. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The Life-Stress Interview is an experiential assessment technique
life-stress interview
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
(No Intervention)

Primary Outcomes

Measure
Symptom Interpretation Questionnaire (SIQ)
time frame: Change from baseline symptom attribution at 6-weeks
Brief Pain Inventory (BPI)
time frame: Change from baseline pain at 6-weeks

Secondary Outcomes

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

Eligibility Criteria

Female participants from 18 years up to 80 years old.

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

Additional Information

Principal investigator Jennifer Carty, M.A.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by William Beaumont Hospitals.