Life-Stress Interview for Women With Chronic Urogenital Pain Conditions

December 13, 2016 updated by: William Beaumont Hospitals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Women's Urology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Participants must have a chronic urogenital pain condition

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Wait-list Control
Experimental: Life-Stress Interview
The Life-Stress Interview is an experiential assessment technique
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Brief Symptom Inventory (BSI)
Time Frame: Change from baseline symptoms at 6-weeks
Change from baseline symptoms at 6-weeks
Patient Health Questionnaire-15 (PHQ-15)
Time Frame: Change from baseline in symptom severity at 6 weeks
Change from baseline in symptom severity at 6 weeks
Satisfaction With Life Scale (SWLS)
Time Frame: Change from baseline life satisfaction at 6-weeks
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
Change from baseline pelvic symptoms at 6-weeks
Global Assessment Response (GRA)
Time Frame: Change from baseline overall symptoms at 6-weeks
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
Change from baseline pain at 6-weeks
Emotional Approach Coping (EAC)
Time Frame: Change from baseline emotional approach coping at 6-weeks
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
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
Change from baseline interpersonal problems at 6-weeks
Pain Catastrophizing Scale
Time Frame: Change from baseline pain catastrophizing at 6-weeks
Change from baseline pain catastrophizing at 6-weeks
Change Assessment Questionnaire
Time Frame: Change from baseline stage of change at 6-weeks
Change from baseline stage of change at 6-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Beaumont Hospitals

Collaborators

Wayne State University

Investigators

  • Principal Investigator: Jennifer Carty, M.A., Beaumont Health Systems and Wayne State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

November 5, 2014

First Submitted That Met QC Criteria

November 5, 2014

First Posted (Estimate)

November 7, 2014

Study Record Updates

Last Update Posted (Estimate)

December 14, 2016

Last Update Submitted That Met QC Criteria

December 13, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIC.2014-151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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