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NCT03623880 · ClinicalTrials.gov registry record · NA
Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT03623880 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 38 participants.
The verdict
NCT03623880, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study Summary
The purpose of this proposal is to test a novel behavioral treatment - Unified Protocol Cognitive-Behavior Therapy (UP-CBT)1 - to enhance quality of life in women with pelvic floor disorders. Emotional distress is treatable using behavioral procedures, and effective treatment would increase women's emotional health and help to reduce urinary symptoms (e.g., incontinence, frequent urination). Women with pelvic floor disorders are often seen in the urogynecology clinic, which makes this setting ideal for offering additional interventions that may improve their quality of life. Unfortunately, many women with pelvic floor disorders may not receive effective behavioral treatment, such as cognitive behavior therapy, because urogynecologists and other medical professionals may not be aware of providers in their community who offer this treatment. The investigators will enhance treatment options by 1) providing evidence for an all-purpose cognitive-behavioral intervention (i.e., UP-CBT), 2) offering treatment in the urogynecology clinic, maximizing convenience, and 3) improving clinical outcomes for these patients. Specific Aims: 1. To demonstrate that UP-CBT is an effective form of therapy for women with lower urinary tract symptoms. 2. To use baseline characteristics in moderation analyses to determine which women will be most likely to have a good response to therapy. 3. To use mediation analyses to test a possible causal chain of events - Does treatment lead to lower anxiety, which in turn leads to fewer urinary symptoms?
Interventions
- BEHAVIORAL Supportive Therapy
- BEHAVIORAL Unified Protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2018-09-03 |
| Est. Completion | 2020-12-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03623880
The ClinicalTrials.gov registry entry for NCT03623880 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Supportive Therapy is the first listed.
NCT03623880 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03623880 about?
NCT03623880 is a clinical study titled "Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders". The purpose of this proposal is to test a novel behavioral treatment - Unified Protocol Cognitive-Behavior Therapy (UP-CBT)1 - to enhance quality of life in women with pelvic floor disorders. Emotional distress is treatable using behavioral procedures, and effective treatment would increase women's ...
What is the current status of trial NCT03623880?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2018-09-03. Estimated completion is 2020-12-10.
What interventions are being tested in trial NCT03623880?
The interventions under investigation include: Supportive Therapy (BEHAVIORAL), Unified Protocol (BEHAVIORAL).
Who is sponsoring clinical trial NCT03623880?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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