Chronic Urogenital PainNCT02286115
Life-Stress Interview for Women With Chronic Urogenital Pain Conditions
A study testing Life-Stress Interview in people with Chronic Urogenital Pain, run by Corewell Health East at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Chronic Urogenital Pain
- What is being tested?
- Life-Stress Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have a chronic urogenital pain condition
Who cannot join
- non-English speaking
- unable to read
- psychosis
- dementia
- mental impairment
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Urogenital Pain
- Being tested
- Life-Stress Interview
- Keywords
- Chronic Pelvic Pain, Interstitial Cystitis, Vulvodynia, Dyspareunia, Pelvic Floor Dysfunction, Emotional Processing
- Medical subject headings
- Cystitis, Interstitial, Vulvodynia, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life-Stress InterviewBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Life-Stress Interview | Experimental | The Life-Stress Interview is an experiential assessment technique Receives: Behavioral: Life-Stress Interview |
| Wait-list Control | No intervention | Wait-list Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Interpretation Questionnaire (SIQ)
Measured: Change from baseline symptom attribution at 6-weeks
Brief Pain Inventory (BPI)
Measured: Change from baseline pain at 6-weeks
Secondary outcomes (11)
Patient Health Questionnaire-15 (PHQ-15)
Measured: Change from baseline in symptom severity at 6 weeks
Brief Symptom Inventory (BSI)
Measured: Change from baseline symptoms at 6-weeks
Satisfaction With Life Scale (SWLS)
Measured: Change from baseline life satisfaction at 6-weeks
Pelvic Floor Distress Inventory -20 (PFDI-20)
Measured: Change from baseline pelvic symptoms at 6-weeks
Global Assessment Response (GRA)
Measured: Change from baseline overall symptoms at 6-weeks
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
Measured: Change from baseline pain at 6-weeks
Emotional Approach Coping (EAC)
Measured: Change from baseline emotional approach coping at 6-weeks
Emotional Processing Scale-25 (EPS-25)
Measured: Change from baseline emotional processing at 6-weeks
Inventory of Interpersonal Problems-32 (IIP-32)
Measured: Change from baseline interpersonal problems at 6-weeks
Pain Catastrophizing Scale
Measured: Change from baseline pain catastrophizing at 6-weeks
Change Assessment Questionnaire
Measured: Change from baseline stage of change at 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Urogenital PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Collaborators
- Wayne State University
- Responsible party
- Sponsor
- Investigators
- Jennifer Carty, M.A., Principal investigator, Beaumont Health Systems and Wayne State UniversityMark A Lumley, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286115
- Sponsor's protocol ID
- HIC.2014-151
- Status last verified
- Dec 2016
- First submitted
- 5 Nov 2014
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32734597
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life-Stress Interview for Women With Chronic Urogenital Pain Conditions
- ClinicalTrials.gov ID
- NCT02286115
- Acronym / sponsor ID
- HIC.2014-151
- Conditions
- Chronic Urogenital Pain
- Keywords
- Chronic Pelvic Pain, Interstitial Cystitis, Vulvodynia, Dyspareunia, Pelvic Floor Dysfunction, Emotional Processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Collaborators
- Wayne State University
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 7 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Life-Stress Interview | Experimental | Behavioral: Life-Stress InterviewThe Life-Stress Interview is an experiential assessment technique |
| Wait-list Control | No intervention | –Wait-list Control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must have a chronic urogenital pain condition
Key exclusion criteria (5 listed)
- non-English speaking
- unable to read
- psychosis
- dementia
- mental impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life-Stress InterviewA 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 | Behavioural | Life-Stress Interview |
Primary outcome
Symptom Interpretation Questionnaire (SIQ)
Time frame: Change from baseline symptom attribution at 6-weeks
Brief Pain Inventory (BPI)
Time frame: Change from baseline pain at 6-weeks
11 secondary outcomes
Patient Health Questionnaire-15 (PHQ-15)
Time frame: Change from baseline in symptom severity at 6 weeks
Brief Symptom Inventory (BSI)
Time frame: Change from baseline symptoms at 6-weeks
Satisfaction With Life Scale (SWLS)
Time frame: Change from baseline life satisfaction at 6-weeks
Pelvic Floor Distress Inventory -20 (PFDI-20)
Time frame: Change from baseline pelvic symptoms at 6-weeks
Global Assessment Response (GRA)
Time frame: Change from baseline overall symptoms at 6-weeks
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
Time frame: Change from baseline pain at 6-weeks
Emotional Approach Coping (EAC)
Time frame: Change from baseline emotional approach coping at 6-weeks
Emotional Processing Scale-25 (EPS-25)
Time frame: Change from baseline emotional processing at 6-weeks
Inventory of Interpersonal Problems-32 (IIP-32)
Time frame: Change from baseline interpersonal problems at 6-weeks
Pain Catastrophizing Scale
Time frame: Change from baseline pain catastrophizing at 6-weeks
Change Assessment Questionnaire
Time frame: Change from baseline stage of change at 6-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Derived from this study: PubMed 32734597Imamura 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Carty, M.A. principal investigator
Beaumont Health Systems and Wayne State University
Mark A Lumley, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life-Stress Interview in people with Chronic Urogenital Pain, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Interpretation Questionnaire (SIQ) (time frame: Change from baseline symptom attribution at 6-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02286115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2016.