Back to results

Life-Stress Interview for Women With Chronic Urogenital Pain Conditions

Primary Purpose

Chronic Urogenital Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Life-Stress Interview

About this trial

This is an interventional treatment trial for Chronic Urogenital Pain focused on measuring Chronic Pelvic Pain, Interstitial Cystitis, Vulvodynia, Dyspareunia, Pelvic Floor Dysfunction, Emotional Processing

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Participants must have a chronic urogenital pain condition

Exclusion Criteria:

non-English speaking
unable to read
psychosis
dementia
mental impairment

Sites / Locations

Women's Urology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Life-Stress Interview

Wait-list Control

Arm Description

The Life-Stress Interview is an experiential assessment technique

Wait-list Control

Outcomes

Primary Outcome Measures

Symptom Interpretation Questionnaire (SIQ)

Brief Pain Inventory (BPI)

Secondary Outcome Measures

Patient Health Questionnaire-15 (PHQ-15)

Brief Symptom Inventory (BSI)

Satisfaction With Life Scale (SWLS)

Pelvic Floor Distress Inventory -20 (PFDI-20)

Global Assessment Response (GRA)

Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)

Emotional Approach Coping (EAC)

Emotional Processing Scale-25 (EPS-25)

Inventory of Interpersonal Problems-32 (IIP-32)

Pain Catastrophizing Scale

Change Assessment Questionnaire

Full Information

NCT ID

NCT02286115

First Posted

November 5, 2014

Last Updated

December 13, 2016

Sponsor

William Beaumont Hospitals

Collaborators

Wayne State University

1. Study Identification

Unique Protocol Identification Number

NCT02286115

Brief Title

Life-Stress Interview for Women With Chronic Urogenital Pain Conditions

Official Title

Life-Stress Interview for Women With Chronic Urogenital Pain Conditions

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

William Beaumont Hospitals

Collaborators

Wayne State University

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Urogenital Pain

Keywords

Chronic Pelvic Pain, Interstitial Cystitis, Vulvodynia, Dyspareunia, Pelvic Floor Dysfunction, Emotional Processing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Life-Stress Interview

Arm Type

Experimental

Arm Description

The Life-Stress Interview is an experiential assessment technique

Arm Title

Wait-list Control

Arm Type

No Intervention

Arm Description

Wait-list Control

Intervention Type

Behavioral

Intervention Name(s)

Life-Stress Interview

Intervention Description

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

Primary Outcome Measure Information:

Title

Symptom Interpretation Questionnaire (SIQ)

Time Frame

Change from baseline symptom attribution at 6-weeks

Title

Brief Pain Inventory (BPI)

Time Frame

Change from baseline pain at 6-weeks

Secondary Outcome Measure Information:

Title

Patient Health Questionnaire-15 (PHQ-15)

Time Frame

Change from baseline in symptom severity at 6 weeks

Title

Brief Symptom Inventory (BSI)

Time Frame

Change from baseline symptoms at 6-weeks

Title

Satisfaction With Life Scale (SWLS)

Time Frame

Change from baseline life satisfaction at 6-weeks

Title

Pelvic Floor Distress Inventory -20 (PFDI-20)

Time Frame

Change from baseline pelvic symptoms at 6-weeks

Title

Global Assessment Response (GRA)

Time Frame

Change from baseline overall symptoms at 6-weeks

Title

Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)

Time Frame

Change from baseline pain at 6-weeks

Title

Emotional Approach Coping (EAC)

Time Frame

Change from baseline emotional approach coping at 6-weeks

Title

Emotional Processing Scale-25 (EPS-25)

Time Frame

Change from baseline emotional processing at 6-weeks

Title

Inventory of Interpersonal Problems-32 (IIP-32)

Time Frame

Change from baseline interpersonal problems at 6-weeks

Title

Pain Catastrophizing Scale

Time Frame

Change from baseline pain catastrophizing at 6-weeks

Title

Change Assessment Questionnaire

Time Frame

Change from baseline stage of change at 6-weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer Carty, M.A.

Organizational Affiliation

Beaumont Health Systems and Wayne State University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mark A Lumley, PhD

Organizational Affiliation

Wayne State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Women's Urology Center

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32734597

Citation

Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.

Results Reference

derived

Learn more about this trial

Life-Stress Interview for Women With Chronic Urogenital Pain Conditions

We'll reach out to this number within 24 hrs