Life-Stress Interview for Women With Chronic Urogenital Pain Conditions

Chronic Urogenital Pain Clinical Trial

Official title:

Life-Stress Interview for Women With Chronic Urogenital Pain Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02286115
• Other study ID #: HIC.2014-151
• Status: Completed
• Phase: N/A
• First received: November 5, 2014
• Last updated: December 13, 2016
• Start date: September 2014
• Est. completion date: January 2016

Study information

• Verified date: December 2016
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Participants must have a chronic urogenital pain condition

Exclusion Criteria:

• non-English speaking

• unable to read

• psychosis

• dementia

• mental impairment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Urogenital Pain
• Stress, Psychological

Intervention

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

Locations

Country	Name	City	State
United States	Women's Urology Center	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
William Beaumont Hospitals	Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom Interpretation Questionnaire (SIQ)		Change from baseline symptom attribution at 6-weeks	No
Primary	Brief Pain Inventory (BPI)		Change from baseline pain at 6-weeks	No
Secondary	Patient Health Questionnaire-15 (PHQ-15)		Change from baseline in symptom severity at 6 weeks	No
Secondary	Brief Symptom Inventory (BSI)		Change from baseline symptoms at 6-weeks	No
Secondary	Satisfaction With Life Scale (SWLS)		Change from baseline life satisfaction at 6-weeks	No
Secondary	Pelvic Floor Distress Inventory -20 (PFDI-20)		Change from baseline pelvic symptoms at 6-weeks	No
Secondary	Global Assessment Response (GRA)		Change from baseline overall symptoms at 6-weeks	No
Secondary	Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)		Change from baseline pain at 6-weeks	No
Secondary	Emotional Approach Coping (EAC)		Change from baseline emotional approach coping at 6-weeks	No
Secondary	Emotional Processing Scale-25 (EPS-25)		Change from baseline emotional processing at 6-weeks	No
Secondary	Inventory of Interpersonal Problems-32 (IIP-32)		Change from baseline interpersonal problems at 6-weeks	No
Secondary	Pain Catastrophizing Scale		Change from baseline pain catastrophizing at 6-weeks	No
Secondary	Change Assessment Questionnaire		Change from baseline stage of change at 6-weeks	No