An interventional study of Unified Protocol and Supportive Therapy in Pelvic Floor Disorders, Anxiety and Urinary Urgency, sponsored by Northwestern University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-30.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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:
212 studies on the registry are indexed under Pelvic Floor Disorders; 46 are open to participants now.
This study's enrollment of 38 is below the median of 63 across 148 interventional studies indexed under Pelvic Floor Disorders.
Browse Pelvic Floor Disorders studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a type of CBT for emotional distress.
Behavioral: Unified Protocol
This is a commonly-used form of all-purpose psychotherapy, often used as a comparator in CBT clinical trials.
Behavioral: Supportive Therapy
The unified protocol is a form of cognitive behavior therapy focused on helping the person reduce emotional distress through cognitive changes and behavioral skills. Exercises included confronting emotional-driven behaviors and mindfulness activities.
Supportive therapy seeks to improve self-esteem, aid the patient with problem solving, and provide structured support using empathetic listening.
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Anxiety 4a T Score
Self-report measure of anxiety symptoms. Min T Score = 40.3; Max T Score = 81.6. Raw scores are summed, then converted to T Scores from a lookup table. Higher T scores represent a worse outcome (i.e., greater number of anxiety symptoms).
Time frame: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Urinary Distress Inventory (UDI-6)
Self-report measure of urinary symptoms and bother. Scores are scale scores: mean value of items answered multiplied by 25; min scale score = 0; max scale score = 100. This scale score can be combined with the scale scores of the Pelvic Organ Prolapse Distress Inventory (POPDI-6) and Colorectal-Anal Distress Inventory (CRAD-8) to form the Pelvic Floor Distress Inventory (PFDI-20) summary score: add three scale scores together (range 0 to 300). Higher score indicates worse outcome (i.e., greater urinary symptoms and bother).
Time frame: 3 months; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6)
Self-report measure of pelvic symptoms and bother. Sores are scale scores: mean value of items answered multiplied by 25; min scale score = 0; max scale score = 100. This scale score can be combined with the scale scores of the UDI-6 and CRAD-8 to form the PFDI-20 summary score: add three scale scores together (range 0 to 300). Higher score indicates worse outcome (i.e., greater pelvic symptoms and bother).
Time frame: 3 months; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Colorectal-Anal distress Inventory 8 (CRAD-8)
Self-report measure of colorectal-anal symptoms and bother. Sores are scale scores: mean value of items answered multiplied by 25; min scale score = 0; max scale score = 100. This scale score can be combined with the scale scores of the POPDI-6 and UDI-6 to form the PFDI-20 summary score: add three scale scores together (range 0 to 300). Higher score indicates worse outcome (i.e., greater colorectal-anal symptoms and bother).
Time frame: 3 months; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Depression 4a T Score
Self-report measure of depression symptoms. Min T Score = 41.0; Max T Score = 79.4. Raw scores are summed, then converted to T Scores from a lookup table. Higher T scores represent a worse outcome (i.e., greater number of depressive symptoms).
Time frame: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Physical Function 4a T Score
Self-report measure of physical function. Min T Score = 22.9; Max T Score = 56.9. Raw scores are summed, then converted to T Scores from a lookup table. Lower T scores represent a worse outcome (i.e., worse physical functioning).
Time frame: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Fatigue 4a T Score
Self-report measure of fatigue. Min T Score = 33.7; Max T Score = 75.8. Raw scores are summed, then converted to T Scores from a lookup table. Higher T scores represent a worse outcome (i.e., greater fatigue).
Time frame: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Sleep Disturbance 4a T Score
Self-report measure of sleep quality and disturbance. Min T Score = 32.0; Max T Score = 73.3. Raw scores are summed, then converted to T Scores from a lookup table. Higher T scores represent a worse outcome (i.e., greater sleep disturbance).
Time frame: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Ability to Participate in Social Roles and Activities 4a T Score
Self-report measure of social role function. Min T Score = 27.5; Max T Score = 64.2. Raw scores are summed, then converted to T Scores from a lookup table. Lower T scores represent a worse outcome (i.e., greater difficulty participating in social roles/activities).
Time frame: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Pain Interference 4a T Score
Self-report measure of pain interference with daily activities. Min T Score = 41.6; Max T Score = 75.6. Raw scores are summed, then converted to T Scores from a lookup table. Higher T scores represent a worse outcome (i.e., greater pain interference).
Time frame: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
PROMIS Pain Intensity
Self-report measure of average pain intensity. One item 0-10 numeric rating scale. Min score = 0, Max score = 10. Higher score represents worse outcome (i.e., greater pain intensity)
Time frame: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient Global Impression of Improvement (PGI-I)
Single item self-report measure of patient perception of improvement in their urinary symptoms compared to before treatment. Rating scale from 1 (very much better) to 7 (very much worse). Lower score represents better outcome (i.e., more improvement).
Time frame: This item assess how the patient is "right now" compared to beginning treatment; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2018 to primary completion in Dec 2020, 27 months.
Of 101 non-industry interventional studies with no phase under Pelvic Floor Disorders, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's 27 months is above that.
Counting every sponsor, half of 107 studies reached it within 16 months; a quarter within 7 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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