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Completed

NCT Number: NCT02286115

Life-Stress Interview for Women With Chronic Urogenital Pain Conditions

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.

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Key information

Conditions

Chronic Urogenital Pain Cystitis Cystitis, Interstitial Dyspareunia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Vulvar Diseases Vulvodynia

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women's Urology Center

Royal Oak, Michigan, 48073, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have a chronic urogenital pain condition

Exclusion criteria

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

Treatment and study plan

Life-Stress Interview

Behavioral

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 outcomes

  1. Symptom Interpretation Questionnaire (SIQ)

    Time frame: Change from baseline symptom attribution at 6-weeks

  2. Brief Pain Inventory (BPI)

    Time frame: Change from baseline pain at 6-weeks

Secondary outcomes

  1. Patient Health Questionnaire-15 (PHQ-15)

    Time frame: Change from baseline in symptom severity at 6 weeks

  2. Brief Symptom Inventory (BSI)

    Time frame: Change from baseline symptoms at 6-weeks

  3. Satisfaction With Life Scale (SWLS)

    Time frame: Change from baseline life satisfaction at 6-weeks

  4. Pelvic Floor Distress Inventory -20 (PFDI-20)

    Time frame: Change from baseline pelvic symptoms at 6-weeks

  5. Global Assessment Response (GRA)

    Time frame: Change from baseline overall symptoms at 6-weeks

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

    Time frame: Change from baseline pain at 6-weeks

  7. Emotional Approach Coping (EAC)

    Time frame: Change from baseline emotional approach coping at 6-weeks

  8. Emotional Processing Scale-25 (EPS-25)

    Time frame: Change from baseline emotional processing at 6-weeks

  9. Inventory of Interpersonal Problems-32 (IIP-32)

    Time frame: Change from baseline interpersonal problems at 6-weeks

  10. Pain Catastrophizing Scale

    Time frame: Change from baseline pain catastrophizing at 6-weeks

  11. Change Assessment Questionnaire

    Time frame: Change from baseline stage of change at 6-weeks

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Collaborators

  • Wayne State University

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Nov 7, 2014
Registry last updated
Dec 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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