Clinical trial NCT02286115: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Urogenital Pain
Keywords: Chronic Pelvic Pain
Interstitial Cystitis
Vulvodynia
Dyspareunia
Pelvic Floor Dysfunction
Emotional Processing
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: Wayne State University
First posted: 2014-11-07
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Participants must have a chronic urogenital pain condition

Exclusion Criteria:

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

Primary outcomes:
measure: Symptom Interpretation Questionnaire (SIQ)
timeFrame: Change from baseline symptom attribution at 6-weeks
measure: Brief Pain Inventory (BPI)
timeFrame: Change from baseline pain at 6-weeks
Secondary outcomes:
measure: Patient Health Questionnaire-15 (PHQ-15)
timeFrame: Change from baseline in symptom severity at 6 weeks
measure: Brief Symptom Inventory (BSI)
timeFrame: Change from baseline symptoms at 6-weeks
measure: Satisfaction With Life Scale (SWLS)
timeFrame: Change from baseline life satisfaction at 6-weeks
measure: Pelvic Floor Distress Inventory -20 (PFDI-20)
timeFrame: Change from baseline pelvic symptoms at 6-weeks
measure: Global Assessment Response (GRA)
timeFrame: Change from baseline overall symptoms at 6-weeks
measure: Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
timeFrame: Change from baseline pain at 6-weeks
measure: Emotional Approach Coping (EAC)
timeFrame: Change from baseline emotional approach coping at 6-weeks
measure: Emotional Processing Scale-25 (EPS-25)
timeFrame: Change from baseline emotional processing at 6-weeks
measure: Inventory of Interpersonal Problems-32 (IIP-32)
timeFrame: Change from baseline interpersonal problems at 6-weeks
measure: Pain Catastrophizing Scale
timeFrame: Change from baseline pain catastrophizing at 6-weeks
measure: Change Assessment Questionnaire
timeFrame: Change from baseline stage of change at 6-weeks
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Women's Urology Center
state: Michigan
Study officials:
affiliation: Beaumont Health Systems and Wayne State University
name: Jennifer Carty, M.A.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Mark A Lumley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.