Life-Stress Interview for Women With Chronic Urogenital Pain Conditions

Sponsor

William Beaumont Hospitals (Other)

Overall Status

Completed

CT.gov ID

NCT02286115

Collaborator

Wayne State University (Other)

Enrollment

Location

Arms

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Urogenital Pain	Behavioral: Life-Stress Interview	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Life-Stress Interview for Women With Chronic Urogenital Pain Conditions

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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
No Intervention: Wait-list Control Wait-list Control

Arm

Intervention/Treatment

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

No Intervention: Wait-list Control

Wait-list Control

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants must have a chronic urogenital pain condition

Exclusion Criteria:

non-English speaking
unable to read
psychosis
dementia
mental impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women's Urology Center	Royal Oak	Michigan	United States	48073

Sponsors and Collaborators

William Beaumont Hospitals
Wayne State University

Investigators

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