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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months; administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Awards & highlights
Summary
This trial is testing whether a cognitive-behavioral therapy intervention can improve quality of life for women with pelvic floor disorders.
Eligible Conditions
- Anxiety
- Pelvic Floor Dysfunction
- Urinary Urgency
- Urinary Incontinence
- Nocturia
- Urinary Frequency/Urgency
- Lower Urinary Tract Symptoms
- Urinary Hesitancy
- Urinary Straining
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months; administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months; administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anxiety
Fetal Distress
Secondary outcome measures
Fetal Distress
PROMIS Pain Intensity
Patient Global Impression of Improvement (PGI-I)
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Unified ProtocolExperimental Treatment1 Intervention
This is a type of CBT for emotional distress.
Group II: Supportive TherapyActive Control1 Intervention
This is a commonly-used form of all-purpose psychotherapy, often used as a comparator in CBT clinical trials.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Unified Protocol
2020
N/A
~410
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,608 Previous Clinical Trials
927,279 Total Patients Enrolled
20 Trials studying Anxiety
14,535 Patients Enrolled for Anxiety
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